65-9569-0

20 Test Kit

For Emergency Use Authorization (EUA) Only

FOR IN VITRO DIAGNOSTIC USE ONLY
R x Only
R x Only

DPP® COVID-19 IgM/IgG System

For Detection of SARS-CoV-2 IgM and IgG Antibodies in Fingerstick Whole Blood, Venous Whole
Blood, Serum and Plasma
Read this Product Insert completely before using the product. Follow the instructions carefully
when performing the test as not doing so may result in inaccurate test results.

STORAGE: Store at 2 to 30°C (36 to 86°F)

NAME AND INTENDED USE

The Chembio DPP® COVID-19 IgM/IgG System is a single-use rapid immunochromatographic test
for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G
(IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma
(lithium heparin or EDTA) samples from patients suspected of COVID-19 infection by a healthcare
provider. The DPP COVID-19 IgM/IgG System is an aid in the diagnosis of patients with suspected
SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory
tests. Results from the DPP COVID-19 IgM/IgG System should not be used as the sole basis for
diagnosis. Testing is limited to laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests.

Results are for the detection of SARS-CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally
detectable in blood several days after initial infection, although levels over the course of infection
are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following
infection. Positive results for both IgG and IgM could occur after infection and can be indicative of
acute or recent infection. Laboratories within the United States and its territories are required to
report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for
patient management decisions. Results must be combined with clinical observations, patient
history, and epidemiological information. IgM antibodies may not be detected in the first few days
of infection; the sensitivity of the DPP COVID-19 IgM/IgG System early after infection is unknown.

False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing
antibodies or other possible causes.

At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.

The DPP COVID-19 IgM/IgG System is only for use under the Food and Drug Administration’s
Emergency Use Authorization. For prescription use only. For in vitro diagnostic use only.

SUMMARY AND EXPLANATION

Coronaviruses are a large family of viruses that are common in people and many different species of
animals. There are seven known types of human coronavirus (HCoV) that cause human respiratory
diseases: HCoV-229E, HCoV- NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV and the novel
“coronavirus disease 2019” (abbreviated “COVID-19”). COVID-19, discovered in 2019 in Wuhan, China,
is caused by infection with the virus “SARS- CoV-2”. Reported illnesses have ranged from very mild
Page 1 of 13 10-6962-0 Rev 2 April 2020
(including some with no reported symptoms) to severe. Symptoms of COVID-19 are fever, fatigue, dry
cough, and other symptoms which can rapidly develop into severe pneumonia, respiratory failure,
septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. which can be life-
threatening.

BIOLOGICAL PRINCIPLES OF THE TEST

The DPP COVID-19 IgM/IgG System includes the DPP COVID-19 IgM/IgG Test Devices and the DPP Micro
Reader or DPP Micro Reader 2 for use with the DPP COVID-19 IgM/IgG System. The device employs
Chembio’s patented DPP (Dual Path Platform) technology and consists of a sample path that distributes
sample onto two assay paths (strips), which include antibody detection test and process control areas
in each readout window of the test cassette (Figure 1).

Figure 1: DPP® COVID-19 IgM/IgG Test Device

The top test strip is for the detection of IgM antibodies to SARS CoV- 2 and the bottom test strip is for
the detection of IgG antibodies to SARS CoV-2. To initiate the test, a 10 µL specimen is diluted with buffer
and applied to the SAMPLE+BUFFER well located in the middle of the sample transfer strip of the DPP
COVID-19 IgM/IgG Test Device. The sample flows in both directions along the sample path membrane
and is delivered to the Top and Bottom test (T1 and T2) and process control (C) areas. SARS CoV-2
antibodies, if present in the sample, bind to the immobilized Nucleocapsid Protein (NP) antigen on the
test areas, while non-specific antibodies bind to the Protein A in the control areas. Five minutes after
adding the sample/buffer mix, 9 drops (~250 µL) DPP IgM/IgG Buffer is added to the BUFFER Well. The
buffer flows onto both test strips, hydrates the two dried antibody- binding colored conjugates, which
migrate to the two test areas. If the sample contains SARS CoV-2 antibodies, the conjugate binds to the
antibodies (IgM or IgG or both if present) captured in the test areas. If only one of the two species of
antibodies is present (IgM or IgG), the conjugate will be captured only at the location of the IgM (top
strip) or IgG (bottom strip) test line.
At the time of reading the results, the DPP Micro Reader or DPP Micro Reader 2 MUST BE USED to
obtain the test results and reports a reactive, nonreactive, or invalid result for the IgM and IgG test lines.
The results must not be visually interpreted.
MATERIALS PROVIDED
Each kit contains the items to perform 20 tests:
• 20 Individually Pouched DPP COVID-19 IgM/IgG Test Devices, each containing a Desiccant
Pouch
• 20 Disposable 10 µL Sample Loops
• 20 Sample Vials/Tubes
Page 2 of 13 10-6962-0 Rev 2 April 2020
 • 20 Transfer Pipets (100 µL)
• 20 Bandages
• 20 Sterile Safety Lancets
• 1 DPP IgM/IgG Buffer
• 9.5 mL, a phosphate buffer containing sodium chloride, EDTA, NP-40, Tween 20, and chicken
serum, urea, antimicrobials and sodium azide as preservative
• 1 Product Insert for the DPP COVID-19 IgM/IgG System
• 1 Fact Sheet for Health Care Providers
• 20 Fact Sheets for Patients

ACCESSORIES AVAILABLE AND REQUIRED

DPP Micro Reader Kit for use with DPP COVID-19 IgM/IgG System Catalog Number 70-1069-0 or 70-
1070-0.

MATERIALS REQUIRED BUT NOT PROVIDED

• Clock, watch, or other timing device
• Pipettor capable of delivering 10-100 µL of sample may be used in lieu of the disposable 10 µL
Sample Loop or 100 µL Transfer Pipets supplied with the Kit (for venous whole blood, serum
or plasma specimens)
• Disposable gloves, Biohazard disposal container, Collection devices (for venous whole blood,
serum, plasma)
• Sterile gauze and antiseptic wipes (for fingerstick whole blood specimens)

WARNINGS
For IN VITRO Diagnostic Use under Emergency Use Authorization only.
1. Use of this product is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high
complexity tests.
2. Read the Product Insert completely before using this assay. Follow the instructions carefully as
not doing so may result in inaccurate test results.
3. Use of this test kit with sample types other than those specifically approved for use with this
device may result in inaccurate test results.
4. This test should be performed at 18 to 30oC (64 to 86oF). If stored refrigerated, ensure that
the pouch and buffer are brought to operating temperature before performing testing.

PRECAUTIONS
SAFETY PRECAUTIONS
1. Specimens may be infectious. Use Universal Precautions when performing this assay.
2. Use routine laboratory precautions. Do not eat, drink or smoke in the area where samples and
kit reagents are handled. Avoid any contact between hands, eyes or mouth during sample
collection and testing.
3. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when
handling patient samples. Wash hands thoroughly after handling specimens and kit reagents.
4. Dispose of all samples and materials used in the test procedure in a biohazard waste container.
Lancets should be placed in a puncture-resistant container prior to disposal. Proper handling
and disposal methods should be established according to local regulations.

HANDLING PRECAUTIONS
1. If Desiccant Packet is missing, DO NOT USE. Discard test device and use a new test device.
2. Do not use any test device if the pouch has been perforated.
3. Each test device is for single use only.
4. Do not use the test beyond the expiration date printed on the pouch. Always check expiration
date prior to testing.
Page 3 of 13 10-6962-0 Rev 2 April 2020
 5. Do not mix reagents from different lot numbers of kits.
6. Ensure finger is completely dry before performing fingerstick.
7. Perform test procedure and read results in a well-lit area.

STORAGE AND STABILITY

The DPP COVID-19 IgM/IgG Test Devices should be stored in unopened pouches at 2 to 30°C (36 to
86°F). Do not freeze. Do not open pouch until you are ready to perform a test. When stored as
indicated, test devices are stable until the expiration date marked on the pouch. The DPP IgM/IgG
Buffer should be stored at 2 to 30°C (36 to 86°F) in its original container.

SPECIMEN COLLECTION
The DPP COVID-19 IgM/IgG System must be performed on fingerstick whole blood, venous whole
blood, serum, or plasma samples (lithium heparin or EDTA).

FINGERSTICK WHOLE BLOOD

Please refer to Test Procedure for collection instructions.
After mixing the fingerstick whole blood specimen with the DPP IgM/IgG Buffer, as described in the
Test Procedure, the sample should be tested immediately.

VENOUS WHOLE BLOOD:

• Draw blood following laboratory procedure for obtaining venous whole blood samples.
• Collect samples in tubes containing anticoagulant (Lithium Heparin or EDTA).
• Collect specimen in a clean container following standard laboratory procedures.
• Be sure the tube of blood is well mixed before sampling.
• If tested the same day, venous whole blood may be kept at room temperature. Venous whole
blood may be stored for up to 3 days between 2 and 8°C (36 to 46°F) before testing.
• DO NOT FREEZE WHOLE BLOOD! Allow refrigerated sample to reach room temperature and
mix gently before testing.

SERUM OR PLASMA:
• Draw blood following laboratory procedure for obtaining serum or plasma samples.
• Collect samples in tubes that do not contain any anticoagulant (serum), or in a tube
containing anticoagulant (plasma).
• Be sure that the tube of serum or plasma is well mixed before sampling.
• Serum and plasma specimens may be tested immediately after collection. If specimens are
not tested immediately, refrigerate them at 2 to 8°C (36 to 46°F) following collection. These
specimens should be tested within 3 days of collection. If specimens are not tested within 3
days of collection, serum or plasma specimens should be frozen at -20°C (-4°F) or colder.

SPECIMEN SHIPPING
If venous whole blood, serum, or plasma specimens are to be shipped, they should be packed in
compliance with regulations covering the transportation of etiologic agents. Venous whole blood,
serum and plasma specimens should be shipped refrigerated with cold packs or wet ice. Fingerstick
specimens must be tested immediately after collection.

TEST PROCEDURE
All components for the DPP COVID-19 IgM/IgG System are ready to use as supplied. Follow
directions as indicated. If the sample and / or kit components have been refrigerated, remove them
from the refrigerator and allow them to come to a temperature of 18 to 30° C (64 to 86°F) prior to
testing.

Page 4 of 13 10-6962-0 Rev 2 April 2020

 Blue Green
1. Remove the DPP COVID-19 IgM/IgG Test Colored
Line
Colored
Line
Test Window:
Device from its pouch and place it on a flat IgM Detection
surface (it is not necessary to remove
the Desiccant Packet from the pouch). Note: If
Desiccant Packet is missing, DO NOT USE, discard
Test Device and use a new Test Device. Write
Patient
ID here
Label the Test Device with patient ID or
identification number.
There are 2 colored lines in each of the Test
Windows. For IgM one is blue and the other is
green. For IgG, one is yellow and the other is
green.
If any of the colored lines are absent from one Test Window: Yellow Green
or both windows, DO NOT USE, discard Test IgG Detection Colored
Line
Colored
Line
Device and use a new Test Device.

2. Transfer 5 drops (~150 µl) of the DPP IgM/IgG

Buffer (Blue cap) into the supplied Sample Vial.

For fingerstick whole blood samples, proceed to

3.a.
For venous whole blood, serum or plasma, proceed
to 3.b.

5X

FINGERSTICK WHOLE BLOOD VENOUS WHOLE BLOOD, SERUM

COLLECTION OR PLASMA COLLECTION

3a. Prepare to perform the fingerstick 3a. For whole blood, serum or plasma
collection procedure. Clean the finger of samples, use a laboratory pipette to draw
the person being tested with an antiseptic 10 µL of the sample from the sample
wipe. Allow the finger to dry thoroughly or collection tube.
wipe dry with a sterile gauze pad.
Using a sterile lancet, puncture the skin just
off the center of the finger and wipe away
the first drop of blood with sterile gauze.
Avoid squeezing the fingertip to accelerate
bleeding as this may dilute the blood with
excess tissue fluid.
Collect the sample from the second drop,
laying the disposable sample loop
provided against the drop of blood until
the sample loop is full as shown below.

Page 5 of 13 10-6962-0 Rev 2 April 2020

 FINGERSTICK WHOLE BLOOD WHOLE BLOOD, SERUM OR
TRANSFER PLASMA TRANSFER

3b Immerse the end of the 3b Immerse the end of

loop filled with blood into the laboratory pipette
the buffer in the sample tip containing the
vial; mix the contents well 10 µL into the buffer in
with the loop; remove and the sample vial; mix the
discard the empty loop in contents well.
the biohazardous waste
container.

3c Fill the transfer pipette up

to the black line (100 µL)
ensuring there are no air
bubbles in the pipette.

With the transfer pipette,

transfer 100 µL of the 3c With the calibrated pipette, Transfer
sample/buffer mixture the 100 µl of sample/buffer mixture
from the sample vial into into Well 1 (Sample+Buffer).
Well 1 (Sample+Buffer).

4. Wait 5 minutes. The blue (IgM) and yellow (IgG) colored lines should have disappeared from the
rectangular TEST and CONTROL windows. The green colored line may or may not disappear.

If the BLUE and YELLOW colored lines do not disappear, DO NOT USE, discard Test Device and use
a new Test Device.

5. Invert the DPP IgM/IgG Buffer bottle (Blue Cap) and hold it VERTICALLY (not at
an angle) over Well 2 (Buffer).
9X
Add 9 drops of Buffer (~250 µl) slowly, dropwise, into Well 2 (Buffer).

A reddish color should begin to flow across both strips within 2-3 minutes.
Otherwise, stop and repeat the test with a new test device.

6. Read the test results using the DPP Micro Reader or DPP Micro Reader 2 between 10 and 15
minutes from the addition of the DPP IgM/IgG Buffer to Well 2 (Buffer) following the
instructions outlined in the DPP Micro Reader or DPP Micro Reader 2 Manual.

NOTE: Discard the used Sample Loop, Test Device, and any other test materials into a
biohazard waste container.
Page 6 of 13 10-6962-0 Rev 2 April 2020
INTERPRETATION OF TEST RESULTS

DO NOT ATTEMPT TO INTERPRET RESULTS OF THE DPP COVID-19 IgM/IgG SYSTEM VISUALLY.
ALWAYS USE THE DPP MICRO READER (OR DPP MICRO READER II) FOR USE WITH THE DPP COVID-
19 IgM/IgG SYSTEM TO OBTAIN RESULTS.

MANUALLY RECORD RESULTS IMMEDIATELY UPON DISPLAY BY THE READER. THE DPP MICRO
READER AND DPP MICRO READER II WILL AUTOMATICALLY SHUT OFF WITHIN 50 SECONDS AND 90
SECONDS, RESPECTIVELY, OF INACTIVITY. RESULTS CANNOT BE RECALLED.

Read the Product Insert accompanying the DPP Micro Reader (or DPP Micro Reader II) completely
before using the product.

IgM and IgG NON-REACTIVE

A NON-REACTIVE Test Result for both IgM and IgG means that antibodies to SARS- CoV-2 were not
detected in the specimen.

The Test Result is interpreted as NON-REACTIVE (i.e. negative). However, a negative result does not
exclude possible infection with COVID-19, particularly in those who have been in contact with the
virus, and should not be used as the sole basis for treatment, patient management decisions, or to
rule out active infection

IgM REACTIVE (R) and IgG NON-REACTIVE (NR)

A REACTIVE IgM test result (i.e., presumed SARS-CoV-2 IgM positive) from the DPP® COVID-19
IgM/IgG System indicates that IgM antibodies to SARS-CoV-2 were detected in the specimen.

If only IgM antibodies were detected, the result is consistent with an active or recent SARS-CoV-2
virus infection.

IgM NON-REACTIVE (NR) and IgG REACTIVE (R)

A REACTIVE IgG test result (i.e., presumed SARS-CoV-2 IgG positive) in the IgG test window means
that IgG antibodies to SARS-CoV-2 were detected in the specimen.

If only IgG antibodies were detected, the result is consistent with a recent or previous infection.

IgM and IgG REACTIVE (R)

A REACTIVE IgM and a REACTIVE IgG test result means that IgM and IgG antibodies to SARS-CoV-2
have been detected in the specimen. The result suggests a current or recent SARS-CoV-2 virus
infection.

INVALID
If the reader returns an INVALID result for IgM OR for IgG, the entire test results are INVALID. An INVALID
test cannot be interpreted. It is recommended that the specimen be re-tested with a new test device.

If the problem persists, please contact Customer Support: +001 631 924 1135 or 1-844-Chembio

Please also refer to the Fact Sheet for Health Care Providers for More Information

Page 7 of 13 10-6962-0 Rev 2 April 2020

QUALITY CONTROL
Built-in Process Control Feature
The DPP COVID-19 IgM/IgG System uses an algorithm including assay-specific cut-off values that
verifies and gives confirmation of sample addition and proper test procedure. Results will be
displayed if the test procedure has been correctly performed. If the test procedure has not been
performed correctly, the results will be displayed on the DPP Micro Reader as Invalid and new test
must be performed. See Test Interpretation Section provided in the DPP Micro Reader or DPP Micro
Reader II Manual. If the problem persists, please contact Chembio Customer Support at +001 631
924 1135 or 1-844-CHEMBIO.

Good laboratory practice suggests that positive and negative controls are run routinely to ensure
that test reagents are working and that the test is correctly performed. External positive and
negative controls should be used in accordance with local, state, federal accrediting organizations,
or your lab’s standard Quality Control procedures, as applicable.

LIMITATIONS OF THE PROCEDURE

• A positive result may not indicate previous SARS-CoV-2 infection. Consider other information,
including clinical history and local disease prevalence, in assessing the need for a second but
different serology test to confirm an immune response.
• False positive results due to cross-reactivity with antibodies to other coronaviruses, (e.g.,
HKU1, 229E, NL63, OC43) can occur.
• The DPP COVID-19 IgM/IgG System must ONLY be used with capillary (fingerstick) whole blood,
venous whole blood, serum or plasma (lithium heparin or EDTA). Using other types of samples
may not yield accurate results. For serum samples, collect blood without anticoagulant.
• The DPP COVID-19 IgM/IgG System must be used in accordance with the instructions in this
product insert to obtain accurate results.
• Reading test results earlier than 10 minutes or later than 15 minutes after the addition of
Buffer to Well 2 may yield erroneous results.
• The results obtained with this test should only be interpreted in conjunction with clinical
findings, and the results from other laboratory tests and evaluations.
• This test should not be used for the screening of donated blood.
• The DPP COVID-19 IgM/IgG System is limited to the qualitative detection of antibodies specific
for the SARS-CoV-2 virus. The intensity of the test line does not necessarily correlate to SARS-
CoV-2 antibody titer in the specimen.
• A negative or non-reactive result can occur if the quantity of antibodies for the SARS-CoV-2
virus present in the specimen is below the detection limit of the assay, or the virus has
undergone minor amino acid mutation(s) in the epitope recognized by the antibody utilized in
the test.
• If symptoms persist and the result from the DPP COVID-19 IgM/IgG System is negative or non-
reactive, it is recommended to re-sample the patient a few days later or test with an alternative
test device.

CONDITIONS OF AUTHORIZATION FOR THE LABORATORY

The DPP COVID-19 IgM/IgG System Letter of Authorization, along with the authorized Fact Sheet
for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are
available on the FDA website: https://www.fda.gov/medical-devices/emergency-situations-
medical-devices/emergency-use-authorizations#covid19ivd. However, to assist clinical
laboratories using the DPP COVID-19 IgM/IgG System (“your product” in the conditions below),
the relevant Conditions of Authorization are listed below:

• Authorized laboratories1 using your product will include with result reports of your product, all
authorized Fact Sheets. Under exigent circumstances, other appropriate methods for
Page 8 of 13 10-6962-0 Rev 2 April 2020
 disseminating these Fact Sheets may be used, which may include mass media.
• Authorized laboratories using your product will use your product as outlined in the Instructions
for Use. Deviations from the authorized procedures, including the authorized instruments,
authorized, authorized clinical specimen types, authorized control materials, authorized other
ancillary reagents and authorized materials required to use your product are not permitted.
• Authorized laboratories that receive your product will notify the relevant public health
authorities of their intent to run your product prior to initiating testing.
• Authorized laboratories using your product will have a process in place for reporting test
results to healthcare providers and relevant public health authorities, as appropriate.
• Authorized laboratories will collect information on the performance of your product and report
to DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and Chembio
Diagnostics, Inc. ([email protected]) any suspected occurrence of false positive
or false negative results and significant deviations from the established performance
characteristics of your product of which they become aware.
• All laboratory personnel using your product must be appropriately trained in
immunochromatographic techniques and use appropriate laboratory and personal protective
equipment when handling this kit, and use your product in accordance with the authorized
labeling. All laboratory personnel using the assay must also be trained in and be familiar with
the interpretation of results of the product.
• Chembio Diagnostics, Inc., authorized distributors, and authorized laboratories using your
product will ensure that any records associated with this EUA are maintained until otherwise
notified by FDA. Such records will be made available to FDA for inspection upon request.
1 The
letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests” as “authorized laboratories.”

PERFORMANCE CHARACTERISTICS
POSITIVE AGREEMENT
Endemic, Symptomatic Subjects
Positive agreement was evaluated using plasma or venous whole blood samples collected from
symptomatic subjects. All subjects were confirmed positive for 2019 Novel Coronavirus by RT-
PCR. The positive population consisted of the following subjects.
• Living in New York during the 2020 COVID-19 pandemic.
• Living in East Asia during the 2020 COVID-19 pandemic.

Table 1: Positive Agreement of the DPP COVID-19 IgM/IgG System According to Days Post Onset of
Symptoms: Endemic Symptomatic Subjects
DPP COVID-19 IgM/IgG System
Days from
2019-nCoV Result as compared to PCR
Symptom Onset Number of
RT-PCR
to Blood Samples
Result IgM (+) IgG (+) IgM (+) and/or IgG (+)
Collection*
≤6 days 4 Pos 1/4=25% 4/4=100% 4/4=100%
7-10 days 10 Pos 7/10=70% 6/10=60% 8/10=80%
11-14 days 4 Pos 3/4=75% 4/4=100% 4/4=100%
15-18 days 11 Pos 11/11=100% 11/11=100% 11/11=100%
19-21 days 2 Pos 2/2=100% 2/2=100% 2/2=100%
24/31=77.4% 27/31=87.1% 29/31=93.5%
Total 31 N/A
95% CI: 60.2% - 88.6% 95% CI: 71.1% - 94.9% 95% CI: 79.3% - 98.2%
*Development of an antibody response to SARS-COVID-2 can take up to 14 or more days post symptom onset1.

1
Juanjuan Zhao et. al, Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019, Clinical Infectious Diseases, ,
ciaa344, https://doi.org/10.1093/cid/ciaa344
Page 9 of 13 10-6962-0 Rev 2 April 2020
Seroconversion
The DPP COVID-19 IgM/IgG System was evaluated using serial plasma (lithium heparin) samples
collected from symptomatic subjects. All subjects were confirmed positive for 2019 Novel
Coronavirus by an FDA EUA RT-PCR. The positive population consisted of 9 subjects from the United
States (New York), from whom 22 specimens were drawn. Plasma samples were collected and
tested 1-22 days after onset of symptoms and within 1 to 16 days after the respiratory specimen
was collected for PCR. Test evaluation results are presented in Table 2.
Table 2: Testing Seroconversion Samples from USA using the DPP COVID-19 IgM/IgG System. Results
are presented as Reflectance Units where ≥25 is reactive and < 25 is nonreactive
nCoV- Days Between DPP COVID-19 IgM/IgG System
Patient ID # 2 PCR Symptom Onset & IgG IgM (+) and/or
IgM (+)
Result Blood Collection (+) IgG (+)
022-01 POS 2 7 2 NR
022-02 N/A 11 129 364 R
027-01 POS 15 4 3 NR
027-02 N/A 20 72 260 R
033-01 POS 9 12 3 NR
033-02 N/A 14 172 87 R
057-01 POS 1 4 6 NR
057-02 N/A 5 57 297 R
081-01 POS 10 13 10 NR
081-02 N/A 14 110 107 R
081-03 POS 17 158 360 R
093-01 POS 15 12 7 NR
093-02 N/A 19 7 10 NR
093-03 N/A 22 163 387 R
114-01 POS 9 8 5 NR
114-02 N/A 13 26 131 R
118-01 POS 9 10 10 NR
118-02 N/A 13 36 136 R
118-03 N/A 15 158 363 R
119-01 POS 12 6 5 NR
119-02 N/A 16 11 5 NR
119-03 N/A 19 107 192 R
R = Reactive, NR = Nonreactive; N/A= Not Applicable

NEGATIVE AGREEMENT
Endemic, Symptomatic Subjects
Negative agreement of the DPP COVID-19 IgM/IgG System was evaluated using 41 samples
collected from symptomatic subjects; two (2) subjects were residing in East Asia (venous whole
blood samples were collected) and thirty-nine (39) subjects were residing in New York (plasma
samples were collected). Samples were collected during the 2020 COVID-19 pandemic and all were
confirmed negative for 2019 Novel Coronavirus by RT-PCR. Results are shown in Table 3a below.

Table 3a: Negative Agreement of the DPP COVID-19 IgM/IgG System: Endemic, Symptomatic Subjects
2019-nCOV DPP COVID-19 IgM/IgG System
Number of results as compared to PCR
Origin RT-PCR
Samples
Result IgM (-) IgG (-) IgM (-) and IgG (-)
2 East Asia Neg 2/2 = 100% 2/2 = 100% 2/2=100%
39 NY, USA Neg 38/39 = 97.4% 36/39=92.3% 35/39=89.7%
40/41 = 97.6% 38/41=92.7% 37/41=90.2%
TOTAL = 41 N/A N/A
95% CI: 87.4% - 99.6% 95% CI: 80.6% - 97.5% 95% CI: 77.5% - 96.1%
Page 10 of 13 10-6962-0 Rev 2 April 2020
Endemic, Asymptomatic Subjects
The specificity of the DPP COVID-19 IgM/IgG System was also evaluated using 49 presumed negative
EDTA venous whole blood specimens collected from asymptomatic individuals from the United
States. The samples were commercially sourced from a blood donation center and collected during
the 2020 COVID-19 pandemic. The resulting negative agreement of the DPP® COVID-19 IgM/IgG
System compared to the expected result was 100% (49/49 = 100%) for IgM and 95.9% (47/49 =
95.9%) for IgG. Results are shown in Table 3b below.

Table 3b: Negative Agreement of the DPP COVID-19 IgM/IgG System for Presumed Negative Samples:
Endemic, Asymptomatic Subjects
DPP COVID-19 IgM/IgG System
Number of
results as compared to expected
Samples
IgM (-) IgG (-) IgM (-) and IgG (-)
49/49=100% 47/49=95.9% 47/49=95.9%
49
95% CI: 92.7% - 100.0% 95% CI: 86.3% - 98.9% 95% CI: 86.3% - 98.9%

Non-Endemic Subjects, Asymptomatic Subjects

The specificity of the DPP COVID-19 IgM/IgG System was evaluated using 25 presumed negative
plasma specimens collected from asymptomatic individuals from the United States. The samples were
commercially sourced from a blood donation center and collected in 2016 before the COVID-19
outbreak. The resulting negative agreement of the DPP COVID-19 IgM/ IgG System compared to the
expected result was 100% (25/25 = 100%) for IgM and 100% (25/25 = 100%) for IgG and as shown in
Table 4.

In addition, the specificity of the DPP COVID-19 IgM/IgG System was evaluated using 32 presumed
negative plasma specimens and 68 presumed negative serum specimens collected from asymptomatic
individuals residing in Brazil. The samples were collected prior to March 2019 before the COVID-19
outbreak. The resulting negative agreement of the DPP COVID-19 IgM/IgG System compared to the
expected result was 97% (97/100 = 97%) for IgM and 96% (96/100 = 96%) for IgG and as shown in Table
4.

Table 4: Negative Agreement of the DPP COVID-19 IgM/IgG System: Non-Endemic,

Asymptomatic Subjects
Number of DPP COVID-19 IgM/IgG System
Samples Origin Matrix results as compared to expected
IgM (-) IgG (-) IgM (-) and IgG (-)
25 USA Plasma 25/25 = 100% 25/25 = 100% 25/25 = 100%
32 Plasma 32/32 = 100% 30/32 = 93.4% 30/32 = 93.4%
68 Brazil Serum 65/68 = 95.6% 66/68 = 97.1% 63/68 = 92.6%
122/125 = 97.6% 121/125 = 96.8% 118/125 = 94.4%
Total = 125 N/A N/A
95% CI: 93.2% - 99.2% 95% CI: 92.1% – 98.7% 95% CI: 88.9% – 97.3%

FINGERSTICK SAMPLE
The performance of the DPP COVID-19 IgM/IgG System was evaluated using fresh, fingerstick
samples prospectively-collected from 11 individuals, 7 of whom were presenting with symptoms.
All samples were collected from hospital workers in the United States (New York), an area endemic
for COVID-19 during the 2019 Novel Coronavirus outbreak. Samples had confirmed results with an
FDA-authorized RT-PCR. Test evaluation results are presented in Table 5.

Page 11 of 13 10-6962-0 Rev 2 April 2020

Table 5: Performance of DPP COVID-19 IgM/IgG System with Fingerstick Samples with Confirmed
nCoV-2 PCR results: Endemic, Hospital Workers
Days DPP COVID-19 IgM/IgG System
nCOV-2 Between Result as compared to PCR
Number
RT-PCR Symptom
of
Result Onset and IgM (+) and/or IgG
Samples IgM (+) IgG (+)
Blood (+)
Collection
6 Positive 14-172 3/6=50% 6/6=100% 6/6=100%
IgM (-) IgG (-) IgM (-) and IgG (-)
5 Negative 7-171 5/5=100% 5/5=100% 5/5=100%

Total Agreement
8/11=72.7% 11/11=100% 11/11=100%
Total=11 N/A N/A
95% CI: 43.4% – 90.3% 95% CI: 74.1% - 100.0% 95% CI: 74.1% - 100.0%
1 For 2 samples the day of symptom onset is unknown
2 For 4 samples the day of symptom onset is unknown

MATRIX COMPARISION
The performance of the DPP COVID-19 IgM/IgG System was evaluated using prospectively-
collected matched EDTA venous whole blood, EDTA plasma and capillary (fingerstick) whole blood
samples from a total of 15 individuals, 6 of whom were presenting with symptoms. All samples
were collected from hospital workers in the United States (New York), an area endemic for COVID-
19 during the 2019 Novel Coronavirus outbreak. Five (5) of the samples from those presenting
with symptoms had PCR-positive confirmed results with an FDA-authorized RT-PCR and are also
discussed in Table 5 above. The results of the plasma and fingerstick samples are compared to the
matched venous whole blood result for each subject. Test evaluation results are presented in Table
6.

Table 6: DPP COVID-19 IgM/IgG System: Matched venous whole blood, plasma and fingerstick
specimens: Endemic, Hospital Workers
DPP COVID-19 IgM/IgG System
Venous
Whole Blood Plasma Fingerstick
(n)
IgM (+) only 3 3/3=100% 3/3=100%
IgG (+) only 1 7 7/7=100% 7/7=100%
IgG (+) and IgM (+)2 5 5/5=100% 43/5=80%
15 15/15=100% 14/15=93.3%
Total
95% CI: 79.6% - 100.0% 95% CI: 70.2% - 98.8%
1 nCoV-2 PCR+ results were available for 2 IgG (+) only subjects. The fingerstick results are also presented in
Table 5 above.
2
nCoV-2 PCR+ results were available for and 3 IgM (+) and IgG (+) subjects. The fingerstick results are also
presented in Table 5 above.
3 One specimen was IgM negative. A PCR result was not available for the subject with the discordant (IgM(-))

fingerstick result.

Cross Reactivity
The DPP COVID-19 IgM/IgG System did not cross react with samples positive for: antibody to
Dengue virus, Chikungunya virus, Zika virus, or Yellow fever virus (post-immunization); human
coronaviruses (NL63 and OC43), antigen to Flu A, Flu B; heterophile antibodies for mononucleosis.
Cross reactivity was observed on the DPP COVID-19 IgM/IgG System with one specimen positive for
Page 12 of 13 10-6962-0 Rev 2 April 2020
 Human Coronavirus 229E and one specimen (of five) positive for human coronavirus HKU1.

Table 7: Cross Reactivity of the DPP COVID-19 IgM/IgG Assay System

DPP COVID-19 IgM/IgG System
Number of
Organisms/Conditions
Samples IgM IgG
POS NEG %CR POS NEG %CR
Anti-Dengue virus
5 0 5 0% 0 5 0%
(IgM and IgG)
Anti-Chikungunya virus
5 0 5 0% 0 5 0%
(IgM and IgG)
Anti-Zika virus (IgM) 5 0 5 0% 0 5 0%
Yellow fever virus post-
5 0 5 0% 0 5 0%
immunization
Human coronavirus
5 0 5 0% 1 4 20%
HKU11
Human coronavirus 229E 1 0 1 0% 1 0 100%
Human coronavirus NL63 2 0 1 0% 0 2 0%
Human coronavirus
1 0 1 0% 0 1 0%
OC43
Influenza A 5 0 5 0% 0 5 0%
Influenza B 5 0 5 0% 0 5 0%
Mononucleosis 5 0 5 0% 0 5 0%
1
The sample that was IgG-antibody reactive on the DPP COVID-19 IgM/IgG System, was confirmed
positive for COVID-19 by a FDA-authorized RT-PCR; a second sample that was found IgM and IgG-
antibody non-reactive on the DPP System was also confirmed positive for COVID-19 by the same
FDA-authorized RT-PCR.

DILUTION OF POSITIVE SAMPLES

Two (2) plasma samples were prospectively-collected from symptomatic patients confirmed positive
by nCoV-2 RT-PCR. Samples were serially-diluted and tested on the DPP COVID-19 IgM/IgG System.
IgM and IgG data are presented in the Table 8 below. This information can also be seen in graph
format, in Figures 1 and 2.

Table 8: Testing of serially-diluted plasma samples on the DPP COVID-19 IgM/IgG System. Results
are presented as Reflectance Units where ≥25 is reactive and <25 is nonreactive.
DPP COVID-19 IgM/IgG System – Sample 1 DPP COVID-19 IgM/IgG System – Sample 2
Dilution IgM IgG IgM IgG
Result Result Result Result
1:15 36 290 128 310
1:30 16 197 223 348
1:60 11 66 140 302
1:120 16 66 62 237
1:240 16 32 49 218
1:580 24 15 49 85
1:1160 12 23 14 54
1:2320 17 9 19 74
1:4640 NT NT 8 21
1:9280 NT NT 11 11
= R, for Reactive; NT= Not Tested
Page 13 of 13 10-6962-0 Rev 2 April 2020
Figure 1: Dilution of IgM-Antibody Positive Figure 2: Dilution of IgG-Antibody Positive
Samples Samples

Page 14 of 13 10-6962-0 Rev 2 April 2020

Ordering Information
Catalog
Product
Number
DPP® COVID-19 IgM/IgG System 65-9569-0
DPP® Micro Reader Kit for Use with DPP COVID-19 IgM/IgG System 70-1069-0

DPP® Micro Reader II Kit for Use with DPP COVID-19 IgM/IgG System 70-1070-0

For Product Information, Literature

and/or SDS please email:
[email protected]

Manufactured by:
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
3661 HORSEBLOCK ROAD
MEDFORD, NY 11763
USA
Tel: +001 631 924 1135

Email: [email protected]
Web Site: www.chembio.com

© Copyright 2020, Chembio Diagnostic Systems,

Inc. The Chembio logo and DPP are trademarks of
Chembio Diagnostic Systems, Inc. ® Indicates a
Chembio trademark registered in the USA.
10-6962-0 Rev 2 April 2020
 For In Vitro Diagnostic Use Only
For Use Under Emergency Use Authorization (EUA) Only
For Prescription Use Only

DPP® Micro Reader 70-1069-0

For Use with the DPP COVID-19 IgM/IgG System

Read this Product Insert completely before using the product.

STORAGE: Store between -20 to 80°C (-4 to 176°F)

NAME AND INTENDED USE

The DPP® Micro Reader is for use with DPP COVID-19 IgM/IgG System.

SUMMARY AND EXPLANATION

The DPP® Micro Reader is a reflectance reader used to obtain test results from DPP® COVID-19 IgM/ IgG
System test devices. The DPP Micro Reader minimizes human errors due to subjective visual reading of
IgM and IgG results; therefore, the DPP COVID-19 IgM/ IgG System was made specifically to be read
with the DPP Micro Reader or the DPP Micro Reader II (refer to the Product Insert for the DPP Micro
Reader II).

PRINCIPLES OF THE PROCEDURE

The DPP Micro Reader is a portable, battery-powered instrument that captures an image of the test
strip surface, verifies the presence and intensity of the control line and measures the line intensity at
each of the test line positions; it interprets the results using a scoring algorithm, and reports a
REACTIVE, NON-REACTIVE or INVALID result after approximately 3 seconds. A 14-segment liquid
crystal display (LCD) on the top of the instrument shows the status of the instrument and displays the
test results to the operator.

The DPP Micro Reader is maintenance free and not configurable by the user and is operated by a
single, multi-function button.

MATERIALS PROVIDED
DPP Micro Reader Kit for use with DPP COVID-19 IgM/IgG System (Catalog 70-1069-0) Each kit
contains:
• 1 DPP Micro Reader (includes 3 batteries)
• 1 Holder for use with DPP Test Device
• 1 Microfiber cloth
• 1 Adapter Cable (5V/1000mA)
• 1 RFID Card for use with DPP COVID-19 IgM/IgG System
• 1 User Manual
WARNINGS
For IN VITRO diagnostic use
The DPP COVID-19 IgM/IgG Assay System test results must be read using the DPP Micro
Reader. The DPP COVID-19 IgM/IgG Assay System test results and must not be visually
interpreted.
• The DPP Micro Reader is calibrated and checked before shipping under strict quality
control measures in order to guarantee a high degree of quality. Do not attempt to
open, re-configure or re-calibrate the DPP Micro Reader.
• The correct RFID cards are required for running the DPP COVID-19 IgM/IgG System tests.
Each RFID card is specific to the assay type being conducted and will transfer test specific
information to the reader before each measurement. Using an RFID card intended for a
different test type than the one performed can result in incorrect test results.
• The DPP Micro Reader requires three (3) CR2032 (3 V/230 mAh) batteries to operate.
Alternatively, it can be powered through the adaptor cable connected to an external
power source.
• Do not use the DPP Micro Reader in direct sunlight or exposed to bright light while reading
results.
• The DPP Micro Reader is designed for use on a clean, flat, horizontal, surface.
• Always ensure that the DPP Micro Reader is positioned correctly in the DPP test device
holder, as described in Operation of the Micro Reader below. Incorrect positioning may
lead to incorrect results.
• The DPP Micro Reader should be operated at 18 to 30°C (64 to 86°F) and between 20% and
85% humidity. Ensure that the DPP Micro Reader is brought to operating temperature before
use.
• Protect the DPP Micro Reader from liquids. Any liquid entering the DPP Micro
Reader may damage it permanently.
• Please follow the instructions in the product insert provided with the test kit regarding the
disposal of DPP test devices containing hazardous or infectious material.
• The DPP Micro Reader itself contains no biological hazards. However, contamination during
use with biological hazards is possible. For cleaning and maintenance, refer to section
CLEANING AND MAINTENANCE.

STORAGE AND STABILITY

The DPP Micro Reader should be stored at temperatures between -20 and 80°C (-4 to 176°F) and
between 20% and 85 % humidity. It should be operated at temperatures between 18 and 30°C (64 to
86°F) and between 20% and 85% humidity.

BATTERY LIFE
Under continuous use, one set of batteries will last for approximately 250- 300 reads (exact number
may vary depending on battery quality, temperature, and length of storage between uses). The status
of the batteries is being monitored and shown on the reader display every time the reader is turned
ON. Verify that the battery symbol is not blinking nor has any bars left. Replace the batteries when
the battery symbol starts to blink. The batteries cannot be recharged and have to be disposed
according to local regulations. Always have a spare set of three batteries. Please see section on
BATTERY INSTALLATION below. Alternatively, the DPP Micro Reader can be powered using the USB
power cable connected to a power source.

Page 2 of 8 10-6966-0 Rev 2 April 2020

BATTERY INSTALLATION

To replace batteries, use three (3) CR2032 (3V/230mAh)

Lithium-ion Coin Cell batteries

Battery
compartment

OPERATION OF THE DPP MICRO READER

1. Ensure that the reader and components are clean. Remove any dust or debris from
bottom camera window. Insert DPP Micro Reader into the supplied holder as shown.

DPP Micro Reader DPP Test Device Holder DPP Micro Reader with Holder

a. Connect the DPP Micro Reader to the supplied holder. Insert the base of the reader so that the
“slanted” edge meets the corresponding “slanted” corner in the holder cavity. The reader should
lay flat in the holder and the button and battery compartment should face the user. The label on
the reader should face the “Chembio" logo on the test device holder, as shown in this figure.
CORRECT INCORRECT
NOT seated
Label properly

“Slanted”
Corner

“Chembio”
Logo
“Slanted” Edge

b. At the time indicated for reading the test results, place the
reader and holder on the TOP IgM Test Window of the device
and push the button. “ON” will appear in the display window.

Page 3 of 8 10-6966-0 Rev 2 April 2020

 IgM TEST PROCEDURE IgG TEST PROCEDURE
Ensure that the DPP Micro Reader is seated in Move the reader to the BOTTOM IgG Test
the IgM test window before proceeding. Press Window. Ensure that the DPP Micro Reader is
the black button. “ON” will appear on the display seated in the IgG test window before
and a beep will sound. proceeding. Press the black button. “ON” will
appear on the display and a beep will sound.

Press the button again; the display will read Press the button again; the display will read
“RFID”. Place the DPP COVID-19 IgM/IgG RFID “RFID”. Place the DPP COVID-19 IgM/IgG RFID
card on top of the reader and a beep will card on top of the reader and a beep will sound.
sound.

Remove the card from the top of the reader Remove the card from the top of the reader
and “TEST” will appear in the display window. and “TEST” will appear in the display window.

Press the button and “RUN” will appear in the Press the button and “RUN” will appear in the
display window. display window.

After approximately 3 seconds, R or NR After approximately 3 seconds, R or NR letters

letters and a numerical value for the IgM and a numerical value for the IgG results will
results will be displayed; IMMEDIATELY be displayed; record the IgG results;
RECORD THE IgM TEST RESULT (refer to IMMEDIATELY RECORD THE IgG TEST RESULT
INTERPRETATION OF TEST RESULTS). (refer to INTERPRETATION OF TEST RESULTS).

WARNING: The reader will turn off automatically after approximately 50 seconds of
inactivity. PREVIOUS TEST RESULTS CANNOT BE RECALLED.
There is no active function to shut off the DPP Micro Reader or to recall the last test
results.

Page 4 of 8 10-6966-0 Rev 2 April 2020

INTERPRETATION OF TEST RESULTS
DO NOT ATTEMPT TO INTERPRET RESULTS OF THE DPP COVID-19 IgM/IgG SYSTEM VISUALLY.
ALWAYS USE THE DPP MICRO READER FOR USE WITH THE DPP COVID-19 IgM/IgG SYSTEM TO
OBTAIN RESULTS. CONSULT DPP MICRO READER USER MANUAL.
THE FOLLOWING WILL
SCROLL ACROSS THE
READER DISPLAY
IgM and IgG NON-REACTIVE
If the numerical results displayed for BOTH IgM and IgG are less than
25, the specimen test result is interpreted as NON-REACTIVE for both IgM 24/NR
IgM and IgG.

A NON-REACTIVE Test Result means SARS-CoV-2 specific antibodies

were not detected in the specimen.
IgG 24/NR
The Test Result is interpreted as NON-REACTIVE (i.e. negative).
However, a negative result does not exclude possible infection with
COVID-19, particularly in those who have been in contact with the virus,
and should not be used as the sole basis for treatment, patient
management decisions, or to rule out active infection.

Please also refer to the Fact Sheet for Health Care Providers for More
Information.

IgM REACTIVE (R) and IgG NON-REACTIVE (NR)

If the numerical result displayed for IgM is greater than or equal to 25,
the specimen test result indicates a REACTIVE SARS-CoV-2 IgM Antibody
Test Result. IgM 25/R

A REACTIVE IgM test result (i.e presumptive SARS-CoV-2 IgM positive)

from the DPP® COVID-19 IgM/IgG System indicates that IgM antibodies
to SARS-CoV-2 were detected in the specimen. IgG 24/NR

If only IgM antibodies were detected, the result is consistent with an

active or recent SARS-CoV-2 virus infection.

Please also refer to the Fact Sheet for Health Care Providers for More Information.

IgM NON-REACTIVE (NR) and IgG REACTIVE (R)

If the numerical result displayed for IgG is greater than or equal to 25, the
specimen test result indicates a REACTIVE SARS-CoV-2 IgG Antibody Test
Result. IgM 24/NR

A REACTIVE IgG test result (i.e. presumptive SARS-CoV-2 IgG positive) in

the IgG test window means that IgG antibodies to SARS-CoV-2 were
detected in the specimen. IgG 25/R

If only IgG antibodies were detected, the result is consistent with a recent
or previous infection.

Please also refer to the Fact Sheet for Health Care Providers for More Information.

Page 5 of 8 10-6966-0 Rev 2 April 2020

INTERPRETATION OF TEST RESULTS, continued

IgM and IgG REACTIVE (R)

If the numerical result displayed for both IgM and IgG is greater than or
equal to 25, the specimen test result indicates a REACTIVE SARS-CoV-2 IgM 25/R
IgM and IgG Antibody Test Result.

A REACTIVE IgM and a REACTIVE IgG test result means that IgM and IgG
antibodies to SARS-CoV-2 have been detected in the specimen. The IgG 25/R
result is IgM and IgG reactive, suggesting current or recent SARS-CoV-2
virus infection.

Please also refer to the Fact Sheet for Health Care Providers for More Information.

INVALID
If the reader returns an INVALID result for IgM OR for IgG, the entire test
INV
results are INVALID. An INVALID test cannot be interpreted. It is
recommended that the specimen be re-tested with a new test device.

If the problem persists, please contact Customer Support: +001-631-924-1135 or 1-844-CHEMBIO.

TURNING OFF THE READER

There is no active function to shut off the DPP Micro Reader; it will turn off automatically after
approximately 50 seconds of inactivity.

CLEANING AND MAINTENANCE

The outer case and display may be cleaned with the enclosed microfiber cloth lightly moistened with 70%
isopropyl alcohol (IPA), 10% bleach solution, or mild soap solution. Do not introduce cleaning solution or
any liquid into the unit. Do not use a saturated towel, which may leak liquid into the case or display
seams. Ensure that the DPP Micro Reader is dry and the surface is free of fluid prior to returning to use. It
is recommended to clean the reader daily.

Before each use, make sure that the window under the reader is clean of finger marks, dust and
lint, which may interfere with the results. It can be wiped with the provided dry microfiber cloth, or
the microfiber cloth lightly moistened with 70% isopropyl alcohol (IPA).

SERVICING AND RE-ORDERING

There are no user serviceable components in the unit with the exception of the replaceable batteries.
For technical issues or questions, and to order a new reader, please contact Chembio Diagnostic
Systems, Inc.
Customer Service Department
Call: 1-844-CHEMBIO or +001 631 924 1135
Email: [email protected]

DISPOSAL
As the DPP Micro Reader may be contaminated by infectious material, it should be disinfected
according to the CLEANING AND MAINTENANCE section above before disposal. Remove the batteries
before disposing of the expired device and dispose of the batteries in accordance with local regulations.

Page 6 of 8 10-6966-0 Rev 2 April 2020

MESSAGES
Messages displayed by the DPP Micro Reader are described in the table below. For assay-specific
messages, see the appropriate product insert.

Messag Type Meaning Action Recommended

e
ON Status Reader is ready for use None
The RFID sticker is attached to the reader to allow the
RFID Status Reader is ready for RFID reader to obtain assay information. Press the button
card and the reader will show TEST
Reader is ready to run a
TEST Status DPP test device Press the button and the reader will show RUN

RUN Status Reader is reading test None

results
INV Status Test results cannot be Re-test the specimen with a new test device
interpreted.
Reader has recorded date Press the button one more time, the reader will show
OK Status and time information ON and is now ready for use
(1) Press the button briefly (<1 second), the display
will show ON.
(2) Verify that the correct RFID card is being used.
The device could not read
(3) Make sure the RFID card is on top of the reader
ERR Error the information from the
after you press the button when the RFID word is in
RFID card
the display.
If the error occurs again, please contact Chembio
Diagnostic Systems, Inc..
An expiration date appears Check the expiration date of the reader, RFID card
DATE Error to be exceeded and the test device in use

SPECIFICATIONS
Dimensions: L x W x H: Approx. 1.6 x 1.6 x 1.6 in. (41 x 41 x 40 mm)
Weight: Approx. 1.4 oz (40 g)
Operation: One button operation
Display: 14-segment LCD
Storage capacity: None
Device measurement period: Approx. 3 seconds
Power supply: 3 batteries CR2032 (3 V/230 mAh)
Or Micro-Reader power cord/USB cable
Interface: 4 pole – 0.1 in (2.5 mm) jack plug for power supply (instead of
battery)
Configuration: Specific configuration program; RFID technology
Measuring field: Min. 0.2 in. (4 mm) width; Max. 0.7 in. (18 mm) length
Lighting: Wavelength 525 nm
Signaling device: Buzzer
Operating conditions: Between 18 and 30°C (64 to 86°F);
between +20 % and +85 % humidity
Storage conditions: Between -20 to 80°C (-4 to 176°F)
between +20 % and 85 % humidity
Degree of protection: IP 20
Lifetime: 3,000 reads

Page 7 of 8 10-6966-0 Rev 2 April 2020

Ordering Information

Product Catalog Number

DPP® COVID-19 IgM/IgG System 65-9569-0
DPP® Micro Reader Kit for Use with DPP® COVID-19
70-1069-0
IgM/IgG System

For Product Information, Literature and/or

SDS please email: [email protected]

Manufactured by:
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
3661 HORSEBLOCK ROAD
MEDFORD, NY 11763 USA
Tel: +001 631 924 1135

Email: [email protected]
Web Site: www.chembio.com

© Copyright 2020, Chembio Diagnostic Systems,

Inc. The Chembio logo and DPP are trademarks of
Chembio Diagnostic Systems, Inc. ® Indicates a
Chembio trademark registered in the USA.

10-6966-0 Rev 2 April 2020

 For In Vitro Diagnostic Use Only
For Use Under Emergency Use Authorization (EUA) Only
For Prescription Use Only

DPP® Micro Reader II 70-1070-0

For Use with the DPP COVID-19 IgM/IgG System

Read this Product Insert completely before using the product.

STORAGE: Store between -20 to 80°C (-4 to 176°F)

NAME AND INTENDED USE

The DPP® Micro Reader II is for use with the DPP COVID-19 IgM/IgG System test cassettes.

SUMMARY AND EXPLANATION

The DPP Micro Reader II is a reflectance reader used to obtain test results from DPP COVID-19 IgM/IgG
System test cassettes. The DPP Micro Reader II minimizes human errors due to subjective visual
interpretation; therefore, the DPP COVID-19 IgM/ IgG System was made specifically to be read with the
DPP Micro Reader II (or DPP Micro Reader).

PRINCIPLES OF THE PROCEDURE

The DPP Micro Reader II is a portable, battery-powered instrument that captures an image of the test
strip surface, verifies the presence and intensity of the control line and measures the line intensity at
each of the test line positions; it interprets the results using a test-specific algorithm, and reports a
REACTIVE, NON-REACTIVE or INVALID result in about ten seconds. A liquid crystal display (LCD) on the
top of the instrument shows the status of the instrument and displays the test results to the operator.

The DPP Micro Reader II is maintenance-free, is not configurable by the user and is operated with a
single, multi-function button.

MATERIALS PROVIDED
DPP Micro Reader II Kit for use with DPP COVID-19 IgM/IgG System (Catalog 70-1070-0) Each kit
contains:
• 1 DPP Micro Reader II
• 3 AA batteries (1.5 V)
• 1 Battery Holder
• 1 RFID card specific for use with the DPP COVID-19 IgM/IgG System
• 1 Micro-USB Cable
• 1 Cleaning brush (for use on the glass of the camera unit under the bottom cover)
• 1 User Manual
WARNINGS AND PRECAUTIONS
For IN VITRO Diagnostic Use
• DPP COVID-19 IgM/IgG System test results must be read using the DPP Micro Reader II (or
DPP Micro Reader) and cannot be visually interpreted.
• The DPP Micro Reader II is calibrated and checked before shipping under strict quality
control measures in order to guarantee a high degree of quality. Do not attempt to open, re-
configure or re-calibrate the DPP Micro Reader II.
• The correct RFID cards are required for running the DPP COVID-19 IgM/IgG System tests.
Each RFID card is specific to the assay type being conducted and will transfer test specific
information to the reader before each measurement. Using an RFID card intended for a
different test type than the one performed can result in incorrect test results.
• The DPP Micro Reader II requires three (3) AA (1.5 V) batteries to operate. Alternatively, it
can be powered through the Micro-USB Cable connected to an external power source.
• Do not use the DPP Micro Reader II in direct sunlight or exposed to bright light while reading
results.
• The DPP Micro Reader II is designed for use on a clean, flat, horizontal surface.
• The DPP Micro Reader II should be operated at 18 to 30°C (64 to 86°F) and between 20%
and 85% humidity. Ensure that the DPP Micro Reader II is brought to operating temperature
before use.
• Protect the DPP Micro Reader II from liquids. Any liquid entering the DPP Micro Reader II
may damage it permanently.
• Please follow the instructions in the product insert provided with the test kit regarding the
disposal of DPP devices containing hazardous or infectious material.
• The DPP Micro Reader II itself contains no biological hazards. However, contamination
during use with biological hazards is possible. For cleaning and maintenance, refer to section
CLEANING AND MAINTENANCE.

Page 2 of 8 10-6963-0 Rev 2 April 2020

STORAGE AND STABILITY
The DPP Micro Reader II should be stored at temperatures between -20 and 80°C (-4 to 176°F) and
between 20% and 85 % humidity. It should be operated at temperatures between 18 and 30°C (64 to
86°F) and between 20% and 85% humidity.

BATTERY LIFE
The DPP Micro Reader II is powered by 3 AA (1.5 V) batteries. Whereas the batteries should allow to
read well over 1,000 tests, always have a spare set of three batteries available. Please see section on
BATTERY INSTALLATION below. Alternatively, the DPP Micro Reader II can be powered using the Micro-
USB cable and USB power source, like a computer USB outlet connection.

UNPACKING AND SET-UP

1. Before using the DPP Micro Reader II, visually inspect the contents for damage. If damage is
apparent, contact Chembio Diagnostic Systems, Inc at +001 631 924 1135 or 1-844-CHEMBIO.
2. Remove the reader from its protective wrapping. It is recommended that the packaging materials
be retained for later use.
3. Ensure that the reader and components are clean. Remove any dust or debris with a smooth,
dry cloth.

BATTERIES INSTALLATION AND REPLACEMENT

The reader requires three (3) AA (1.5 V) batteries. Follow the directions below for battery installation
and replacement. Replace the batteries if the battery symbol is blinking. To replace the batteries, turn
the reader upside down and open the maintenance and battery hatch. Remove the battery holder
from the DPP Micro Reader II. Replace the spent batteries with three fresh AA batteries, properly
orienting them to match their poles with the polarity signs inside the holder. Once the batteries have
been replaced, insert the holder back into the DPP Micro Reader II: the battery holder only fits one
way: with the round corners pointing towards the back of the device, and a crease in the holder fitting
with a fin inside the holder cavity. The holder will make an audible “click” when inserted correctly
into place. Once the battery holder is installed, replace the hatch. See Figure 1 formore clarification.

NOTE: In order to maintain Date and Time settings during battery replacement, it is recommended
to replace the batteries within 5 minutes from removal. If the date and time is present on the display
at the time the batteries are removed for replacement, the date and time settings will not be affected.
If incorrect date and time settings are observed after battery replacement, refer to the following
instructions in the section on SETTING THE DATE AND TIME to correct the Date and Time settings.

If you have any questions, please contact Chembio Customer Support at:
+001 631 924 1135 or 1-844-CHEMBIO.

Figure 1: Battery installation and replacement in the DPP Micro Reader II

1 2 3 4

Page 3 of 8 10-6963-0 Rev 2 April 2020

SETTING THE DATE AND TIME

1 To set the date and time, if the instrument is off, briefly press the operating button (less than
one second) or insert a DPP test. The display turn will turn on.

Display

Operating
button

Cassette compartment
Main Screen when turned “on”.

2 Hold the button down for >1 second. The 3 Use the single operating button to scroll
menu “option” will appear on the screen. down to “Setup” in 3 short presses (<1
second).

2020-31-03 02:49 PM 2020-31-03 02:49 PM

Selection menu Selection menu
Back to main Back to main
Show results Show results
Setup Setup

4 Hold the button down for >1 second to enter 5 Hold the button down for >1 second to enter
“Set-up” mode. Use the single operating “Set clock and date” mode. Using short
button to scroll down to “Set clock and date” presses (<1 second), set the clock and date.
in 2 short presses (<1 second).
2020-31-03 02:49 PM 2020-31-03 02:49 PM
Setup Set Clock and date
Back to main Back to main
Device Information HH : MM 24 hr 14:09
Set clock and date Year / Month Day 2020-31-03
Select Language Date format YDM
LCD configuration
Device configuration Set clock/date --> back to main

5 After seting the clock and date, hold the button down for >1 second to go “back to main”
screen.

Page 4 of 8 10-6963-0 Rev 2 April 2020

 PROCEDURE: READING DPP IgM/IgG SYSTEM TESTS ON THE DPP MICRO READER II
1 Ensure that the reader and components are clean (use supplied cleaning brush). The DPP Micro
Reader II is designed for use on a straight, horizontal, and non-metallic surface.

Display

Operating
button
White
Arrow Micro-USB
connection
RFID card
Cassette holder
compartment

2 For one-step reading of the test results: insert the RFID card in the holder on the back of the
instrument.

3a Insert the cassette fully in the front opening. The 3b The following will be
IgM and IgG Test Windows and Well 1 (Sample + displayed on the screen:
Buffer) should be completely embedded in the
preparing…
DPP Micro Reader II. Only Well 2 (Buffer) should
remain visible. The white arrow on the starting evaluation
instrument should line up with the area for
writing the patient ID. capturing
The instrument will turn on automatically when
the cartridge is fully and correctly inserted. It will calculating
then read the RFID card, display the test name and
information, start the reading sequence and
display the test results.
4 When the read is complete, the test results will appear on the display for each line.
See INTERPRETATION OF TEST RESULTS

If the line in the IgM and/or IgG CONTROL (C) area is too weak or absent, the DPP Micro Reader II will
display “INV”, indicating that the test is INVALID.

An invalid result indicates a problem with running the test, either related to the specimen, the device,
or the procedure followed. An invalid test cannot be interpreted;
it is recommended that the specimen be retested with a new device.

Record the IgM and IgG test result according to the

laboratory policy (refer to INTERPRETATION OF TEST RESULTS)
as the DPP Micro Reader II does NOT record
or store results for future reference.
The results will remain visible for 90 seconds
or until another cassette is inserted.
The reader will automatically shut off after
90 seconds if another cassette in not inserted.
Page 5 of 8 10-6963-0 Rev 2 April 2020
INTERPRETATION OF TEST RESULTS

DO NOT ATTEMPT TO INTERPRET RESULTS OF THE DPP COVID-19 IgM/IgG SYSTEM VISUALLY.
ALWAYS USE THE DPP MICRO READER II (OR DPP MICRO READER) FOR USE WITH THE DPP COVID-
19 IgM/IgG SYSTEM TO OBTAIN RESULTS. USING AN RFID CARD INTENDED FOR A DIFFERENT TEST
TYPE THAN THE ONE PERFORMED CAN RESULT IN INCORRECT TEST RESULTS.

IgM and IgG NON-REACTIVE

If the numerical results displayed for BOTH IgM and IgG are less than 25, the specimen test result is
interpreted as NON-REACTIVE for both IgM and IgG.

A NON-REACTIVE Test Result means that antibodies to SARS- CoV-2 were not detected in the
specimen.

The Test Result is interpreted as NON-REACTIVE (i.e. negative). However, a negative result does not
exclude possible infection with COVID-19, particularly in those who have been in contact with the
virus, and should not be used as the sole basis for treatment, patient management decisions, or to
rule out active infection

Please also refer to the Fact Sheet for Health Care Providers for More Information

IgM REACTIVE (R) and IgG NON-REACTIVE (NR)

If the numerical result displayed for IgM is greater than or equal to 25, the specimen test result
indicates a REACTIVE SARS-CoV-2 IgM Antibody Test Result.

A REACTIVE IgM test result (i.e., presumptive SARS-CoV-2 IgM positive) from the DPP® COVID-19
IgM/IgG System indicates that IgM antibodies to SARS-CoV-2 were detected in the specimen.

If only IgM antibodies were detected, the result is consistent with an active or recent SARS-CoV-2
virus infection.

Please also refer to the Fact Sheet for Health Care Providers for More Information

IgM NON-REACTIVE (NR) and IgG REACTIVE (R)

If the numerical result displayed for IgG is greater than or equal to 25, the specimen test result
indicates a REACTIVE SARS-CoV-2 IgG Antibody Test Result.

A REACTIVE IgG test result (i.e., presumptive SARS-CoV-2 IgG positive) in the IgG test window means
that IgG antibodies to SARS-CoV-2 were detected in the specimen.

If only IgG antibodies were detected, the result is consistent with a recent or previous infection.

Please also refer to the Fact Sheet for Health Care Providers for More Information

IgM and IgG REACTIVE (R)

If the numerical result displayed for both IgM and IgG is greater than or equal to 25, the specimen
test result indicates a REACTIVE SARS-CoV-2 IgM and IgG Antibody Test Result

A REACTIVE IgM and a REACTIVE IgG test result means that IgM and IgG antibodies to SARS-CoV-2
have been detected in the specimen. The result suggests a current or recent SARS-CoV-2 virus
infection.
Please also refer to the Fact Sheet for Health Care Providers for More Information
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INTERPRETATION OF TEST RESULTS, continued

INVALID
If the reader returns an INVALID result for IgM OR for IgG, the entire test results are INVALID. An INVALID
test cannot be interpreted. It is recommended that the specimen be re-tested with a new test device.

If the problem persists, please contact Customer Support: +001 631 924 1135 or 1-844-Chembio

TURNING OFF THE READER

There is no active function to shut off the DPP Micro Reader II; it will turn off automatically after
approximately 90 seconds of inactivity.

CLEANING AND MAINTENANCE

The outer case and display may be cleaned with the enclosed microfiber cloth lightly moistened with 70%
isopropyl alcohol (IPA) or mild soap solution. Do not introduce cleaning solution or any liquid into the unit.
Do not use a saturated towel, which may leak liquid into the case or display seams. Ensure that the DPP
Micro Reader II is dry and the surface is free of fluid prior to returning to use. It is recommended to clean
the reader daily.

If the inside of the DPP Micro Reader II becomes contaminated by a DPP test, a cotton swab with IPA
or 10% bleach solution may be used to clean hard to reach surfaces. Be sure that the windows
(accessed through the hatch on the bottom of the reader) are clear of dust and lint, and use provided
brush to clean if required.

SERVICING AND RE-ORDERING

The reader does not need calibration, there are no user serviceable components in the unit with
the exception of the replaceable batteries. For technical issues or questions, and to order a new
reader, please contact Chembio Diagnostic Systems, Inc.

Customer Service Department

Call: 1-844-CHEMBIO or +001 631 924 1135
Email: [email protected]

DISPOSAL
As the DPP Micro Reader II may be contaminated by infectious material, it should be disinfected
according to the CLEANING AND MAINTENANCE section above before disposal. Remove the batteries
before disposing of the expired device and dispose of the batteries in accordance with local regulations.

SPECIFICATIONS
Description: Reader for quantifying lateral flow assays from Chembio
Test format: Test cassette DPP
Measurement: Device for quantification, semi-quantification or qualification of test-
line intensity – also adaptable for multiple test-line measurements
Dimensions: L x W x H: Approx. 3.9 x 3.9 x 4.2 in. (100 x 98 x 106 mm)
Weight: 9.4 oz (267.6 g); with batteries inserted: 11.9 oz (337 g)
Operation: One button operation
Display: 240x160 pixel, monochrome LCD
Storage capacity: 7000 test results
Device measurement period: Approx. 90 seconds
Power supply: 3 AA batteries (1.5 V), or DPP Micro Reader II-Micro-USB cable
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Ordering Information
Product Catalog Number
DPP® COVID-19 IgM/IgG System 65-9569-0
DPP® Micro Reader II Kit for Use with DPP® COVID-19
70-1070-0
IgM/IgG System

For Product Information, Literature

and/or SDS please email:
[email protected]

Manufactured by:
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
3661 HORSEBLOCK ROAD
MEDFORD, NY 11763
USA
Tel: +001 631 924 1135

Email: [email protected]
Web Site: www.chembio.com

© Copyright 2020, Chembio Diagnostic Systems,

Inc. The Chembio logo and DPP are trademarks of
Chembio Diagnostic Systems, Inc. ® Indicates a
Chembio trademark registered in the USA.

10-6963-0 Rev 2 April 2020