Document No.

: INS-HC_E-EN
Revision date : July 17, 2020 (Rev. 03)
 The sample diluent pre-dispensed in a tube contains
phosphate buffered saline (PBS). The sample diluent is

  packed in a box.

WARNINGS AND PRECAUTIONS 

β-HCG Plus   


For in vitro diagnostic use only.
Follow the instructions and procedures described in this
‘Instruction for use’.
 Use only fresh samples and avoid direct sunlight.
 Lot numbers of all the test components (cartridge,
INTENDED USE  detector tube, detector diluent and sample diluent and ID
ichroma™ β-HCG Plus is a fluorescence Immunoassay (FIA) chip) must match each other.
 Do not interchange the test components between
for the quantitative determination of β-HCG in human whole
different lots or use the test components after the
blood/serum/plasma.  It is useful as an aid in management
and monitoring of beta human chorionic gonadotropin (β- expiration date, either of which might yield incorrect test
result(s).
hCG) level in human
For in vitro diagnostic use only.  Do not reuse cartridges or detector tube. A cartridge
should be used for testing one sample only. A detector
INTRODUCTION  tube should be used for processing of one sample only.
 The cartridge should remain sealed in its original pouch
Beta human chorionic gonadotropin (β-hCG) is a
until just before use. Do not use the cartridge, if pouch is
glycoprotein hormone secreted by the developing placenta
damaged or has already been opened.
shortly after implantation. β-hCG can be detected in the
 Frozen sample should be thawed only once. For shipping,
urine and serum of pregnant women as early as 6 to 15 days
samples must be packed in accordance with local
after conception. The concentration of hCG increases to 50
regulations. Sample with severe hemolysis and/or
mIU/mL one week post implantation and reaches to about
hyperlipidemia must not be used.
100 mIU/mL at the time of the first missed menstrual period
 Allow the cartridge, detector tube, detector diluent,
and the peak at 100,000-200,000 mIU/mL at the first
sample diluent and sample to be at room temperature for
trimester.
approximately 30 minutes before use.
PRINCIPLE   The instrument for  ichroma™  β-HCG  Plus tests may
generate slight vibration during use.
The test uses a sandwich immunodetection method; the
 Used cartridges, detector tubes, detector diluent, sample
detector antibodies in buffer bind to antigens in the sample,
diluents and pipette tips should be handled carefully and
forming antigen-antibody complexes, and migrate onto the
discarded by an appropriate method in accordance with
nitrocellulose matrix to be captured by the other
relevant local regulations.
immobilized-antibody on test strip.
 An exposure to larger quantities of sodium azide may
More antigens in the sample will form more antigen-
cause certain health issues like convulsions, low blood
antibody complexes which lead to stronger fluorescence
pressure and heart rate, loss of consciousness, lung injury
signal by detector antibodies, which is processed by
and respiratory failure.
instrument for ichroma™ tests to show β-hCG concentration
 ichroma™  β-HCG  Plus will provide accurate and reliable
in the sample.
results subject to the below conditions.
COMPONENTS  - ichroma™  β-HCG  Plus should be used only in
conjunction with the instrument for ichroma™ tests.
ichroma™  β-HCG Plus consists of ‘cartridges’, ‘detector
- Have to use recommended anticoagulant sample.
tubes’, ‘detector diluent’, ‘sample diluents’, ‘ID chip’ an
Recommended anticoagulant
‘Instruction for use’.
 The cartridge contains the membrane called a test strip
K2 EDTA, K3 EDTA, Sodium Heparin
which has streptavidin at the test line, and chicken IgY at
STORAGE AND STABILITY 
the control line. All cartridges are individually sealed in an
aluminum foil pouch containing a desiccant in a box. Storage condition
 The detector tube has 2 granules containing anti human Storage
Component Shelf life Note
β-HCG-fluorescence conjugate, anti-chicken IgY- Temperature
fluorescence conjugate, bovine serum albumin (BSA) as a Cartridge 4 - 30 °C 20 months Disposable
stabilizer and sodium azide as a preservative in phosphate Detector tube 2 - 8 °C  20 months Disposable
buffered saline (PBS). All detector tubes are packed in a 20 months Unopened
pouch. All detector tubes are packed in a box. Detector diluent 2 - 8 °C
12 months Opened
 The detector diluent contains bovine serum albumin (BSA) Sample diluent 2 - 8 °C 24 months Disposable
as a stabilizer, detergent, sodium azide as a preservative in  After the cartridge pouch is opened, the test should be
phosphate buffered saline (PBS), and its is pre-dispensed performed immediately.
in a vial. The detector diluent is packed in a box.

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Document No. : INS-HC_E-EN
Revision date : July 17, 2020 (Rev. 03)

LIMITATION OF THE TEST SYSTEM   However, the whole blood sample should not be kept in a

freezer in any case.
 The test may yield false positive result(s) due to the cross-  Once the sample was frozen, it should be thawed one time
reactions and/or non-specific adhesion of certain sample and only for test, because repeated freezing and thawing
components to the capture/detector antibodies. can result in the changed test values.
 The test may yield false negative result(s) due to non-
responsiveness of the antigen to the antibodies which is TEST SETUP 
most common if the epitope is masked by some unknown
 Check the contents of ichroma™  β-HCG  Plus: Sealed
components, so therefore not being able to be detected
cartridges, detector tubes, detector diluent, sample
or captured by the antibodies. The instability or
diluents, ID chip and an instruction for use.
degradation of the antigen with time and/or temperature
 Ensure that the lot number of the cartridge matches that
may also cause the false negative result as it makes
of the detector tube, detector diluent, sample diluent as
antigen unrecognizable by the antibodies.
well as an ID chip.
 Other factors may interfere with the test and cause
 If the sealed cartridge, detector tube, detector diluent and
erroneous results, such as technical/procedural errors,
sample diluent have been stored in a refrigerator, place
degradation of the test components/reagents or presence
them on a clean and flat surface at room temperature for
of interfering substances in the test samples.
at least 30 minutes before testing.
 Any clinical diagnosis based on the test result must be
 Turn on the instrument for ichroma™ test.
supported by a comprehensive judgment of the
(Please refer to the ‘Instrument for ichroma™ tests
concerned physician including clinical symptoms and
Operation Manual’ for complete information and
other relevant test results.
operating instructions.)
MATERIALS SUPPLIED 
TEST PROCEDURE 
REF CFPC-66
 ichroma™ II 
Components of ichroma™ β-HCG Plus <Multi mode> 
 Cartridge Box: 1) Transfer 150 µL of detector diluent using a pipette to a
- Cartridge 25 detector tube containing granules. When the granule
- ID chip 1 form is completely dissolved in the tube, it becomes
- Instruction for Use 1 detection buffer. The detection buffer must be used
 Buffer Box immediately within 1 minute.
 For ichroma™ II 2) Transfer sample 10 µL (Human whole blood/serum/
- Detector tube (Capped with plastic lid) 25 plasma/control) using a pipette to a detector tube.
- Detector diluent 1 3) Close the lid of the detector tube and mix the sample
 For ichroma™-50 thoroughly by shaking it about 20 times. The sample
- Detector tube (Sealed with aluminum foil) 25 mixture must be used immediately within 1 minute.
- Detector diluent 1 4) Pipette out 75 µL of a sample mixture and load it into
 Sample Diluent Box: the sample well on the cartridge.
- Sample diluent 25 5) Leave the sample-loaded cartridge at room temperature
for 12 minutes before inserting the device into the
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND  holder.
Following items can be purchased separately from Scan the sample-loaded cartridge immediately when
ichroma™ β-HCG Plus. the incubation time is over. If not, it will cause inaccurate
Please contact our sales division for more information. test result.
 Instrument for ichroma™ tests 6) To scan the sample-loaded cartridge, insert it into the
- ichroma™ II REF FPRR021 cartridge holder of the instrument for ichroma™ tests.
- ichroma™-50 REF FPRR022 Ensure proper orientation of the cartridge before
 Boditech Hormone Control REF CFPO-95 
pushing it all the way inside the cartridge holder. An
  arrow is marked on the cartridge especially for this
SAMPLE COLLECTION AND PROCESSING  purpose.
 
7) Tap the ‘START’ button on the instrument for ichroma™
The sample type for ichroma™ β-HCG Plus is human whole
blood/serum/plasma. tests to start the scanning process.
8) The instrument for ichroma™ tests will start scanning
 It is recommended to test the sample within 24 hours after
collection. the sample-loaded cartridge immediately.
9) Read the test result on the display screen of the 
 The serum or plasma should be separated from the clot by
centrifugation within 3 hours after the collection of whole instrument for ichroma™ tests.
blood. If longer storage is required, e.g. if the test could <Single mode> 
not be performed within 24 hours, serum or plasma 1) Transfer 150 µL of detector diluent using a pipette to a
should be immediately frozen below -20 °C. The freezing detector tube containing granules. When the granule
storage of sample up to 3 months does not affect the form is completely dissolved in the tube, it becomes
quality of results. detection buffer. The detection buffer must be used

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Document No. : INS-HC_E-EN
Revision date : July 17, 2020 (Rev. 03)

immediately within 1 minute. 9) When the selected cartridge slot is activated, set the
2) Transfer sample 10 µL (Human whole blood/serum/ number of test cartridge by tapping.
plasma/control) using a pipette to a detector tube. 10)Tap the button located in the upper side of the No. of
3) Close the lid of the detector tube and mix the sample reagent region to select ID chip what you want to use.
thoroughly by shaking it about 20 times. The sample 11)When the selected slot is activated, set the number of
mixture must be used immediately within 1 minute. detector by tapping.
4) Pipette out 75 µL of a sample mixture and load it into 12)Set the number of pipette tips by tapping.
13)Tap the ‘START’ button on the left upper of the main
the sample well on the cartridge.
5) Insert the sample-loaded cartridge into the holder of the screen to start test.
instrument for ichroma™ tests. Ensure proper
< Using sample diluent >
orientation of the cartridge before pushing it all the way When the concentration of a sample is higher than
inside the cartridge holder. An arrow is marked on the 5,000 mIU/mL, it can be diluted with a sample diluent
cartridge especially for this purpose. provided.
6) Tap the ‘START’ button on the instrument for ichroma™ 1) Transfer sample 10 μL (Human whole blood/serum/
tests. plasma/control) using a pipette to a sample diluent.
7) Cartridge goes inside the Instrument for ichroma™ tests 2) After using sample diluent, please follow the test
and will automatically start scanning the sample-loaded methods from ① to ⑬
cartridge after 12 minutes. (Please refer to the ichroma™-50 operation manual for
8) Read the test result on the display screen of the  complete information and operation instructions.)
instrument for ichroma™ tests.
INTERPRETATION OF TEST RESULT 
< Using sample diluent >  The instrument for ichroma™ tests calculates the test
When the concentration of a sample is higher than result automatically and displays β-HCG concentration of
5,000 mIU/mL, it can be diluted with a sample diluent the test sample in terms of mIU/mL.
provided.  Cut-off (reference value): 5 mIU/mL
1) Transfer 150 µL of detector diluent using a pipette to a  Total ß-HCG level during pregnant stage
detector tube containing granules. When the granule pregnant women Total βhCG level [mIU/mL]
form is completely dissolved in the tube, it becomes (weeks since LMP*) range
detection buffer. The detection buffer must be used
3 5 - 50
immediately within 1 minute.
4 5 - 426
2) Transfer sample 10 μL (Human whole blood/serum/
plasma/control) using a pipette to a sample diluent. 5 18 - 7,340
3) Transfer diluted sample 10 μL using a transfer pipette to 6 1,080 – 56,500
a detector tube. 7-8 7,650 – 229,000
4) After adding diluted sample to a detector tube, please 9 - 12 25,700 – 288,000
follow the test methods as below in each test mode. 13 - 16 13,300 – 254,000
<Single mode> From ③ to ⑧ 17 - 24 4,060 – 165,400
<Multi mode> From ③ to ⑨ 25 - 40 3,640 – 117,000
(Please refer to the ichroma™ II operation manual for ※ LMP is the last menstrual periods date from the first day
complete information and operation instructions.) of your last period
※ The hCG levels different for each person, so the result
 ichroma™-50  should be consulted by a doctor about the pregnancy
1) Insert the tip array in the tip station. cycle.
2) Insert the detector array in the reagent station and cover ※ To confirm the exact pregnancy, retest 2-3 days after the
the reagent station. first measurement.
3) Open the detector diluent and insert the detector  Working range : 2 - 5,000 mIU/mL
diluent in the diluent station.  In case of the test is performed with sample dilution
4) Open the cover of the magazine station and pull and lift procedure, please follow the below equation to obtain
the cartridge magazine. correct result.
5) Insert the cartridges in the cartridge magazine [Final Sample Concentration = Reported Concentration x 50]
individually.
6) Insert the cartridge loaded cartridge magazine into the
magazine station and close the cover of the magazine
station.
7) Insert the sample tube into the blood collection tube
rack and load the blood collection tube rack into the
sampling station (loading part).
8) Tap the button located in the upper side of the No. of
test cartridge region to select ID chip what you want to
use.
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Document No. : INS-HC_E-EN
Revision date : July 17, 2020 (Rev. 03)

QUALITY CONTROL   Precision
- Between Lot
 Quality control tests are a part of the good testing practice One person tested three different lots of ichroma™ β-
to confirm the expected results and validity of the assay HCG Plus, ten times at each concentration of the control
and should be performed at regular intervals. standard.
 The control tests should be performed immediately after - Between person
opening a new test lot to ensure the test performance is - Three different persons tested ichroma™  β-HCG  Plus, 
not altered. ten times at each concentration of the control standard.
 Quality control tests should also be performed whenever - Between day
there is any question concerning the validity of the test One person tested ichroma™  β-HCG  Plus  during five
results. days, five times at each concentration of the control
 Control materials are not provided with ichroma™ β-HCG  standard.
Plus. For more information regarding obtaining the control - Between site
materials, contact Boditech Med Inc.’s Sales Division for One person tested ichroma™  β-HCG  Plus  at three
assistance. different sites, five times at each concentration of the
(Please refer to the instruction for use of control material.) control standard.
Whole blood type
PERFORMANCE CHARACTERISTICS 
Conc. between Lot between person
 Analytical sensitivity  (mIU/mL) AVG CV (%) AVG CV (%)
Sample Type Whole Blood Serum/Plasma 5 4.89 4.78 5.04 4.55
Limit of Blank 800 785.94 3.44 792.89 4.99
0.2 mIU/mL 0. 1 mIU/mL
(LOB) 2500 2454.94 4.14 2485.2 5.45
Limit of Detection Conc. between day between site
0.5 mIU/mL 0.4 mIU/mL
(LOD) (mIU/mL) AVG CV (%) AVG CV (%)
Limit of Quantitation 5 5.01 4.34 5 4.5
2 mIU/mL 1.8 mIU/mL
(LOQ) 800 785.88 4.43 779.38 2.47
 

 Analytical specificity  2500 2453.95 4.88 2487.85 5.32

- Cross-reactivity Serum/Plasma type
Biomolecules such as below the ones in the table were Conc. between Lot between person
added to the test sample(s) at concentrations much (mIU/mL) AVG CV (%) AVG CV (%)
higher than their normal physiological levels in the 5 5 3.71 4.98 4.81
blood. ichroma™ β-HCG Plus test results did not show 800 801.26 5.18 814.94 4.03
any significant cross-reactivity with these biomolecules. 2500 2462.38 4.99 2541.03 4.65
Cross-reactivity material Cross reactivity (%) Conc. between day between site
TSH (500uIU/mL) < 0.8 (mIU/mL) AVG CV (%) AVG CV (%)
FSH (1,000mIU/mL) < 0.03 5 5.04 3.36 4.96 5.03
LH (1,000mIU/mL) < 0.5 800 778.18 3.99 796.16 3.27
2500 2515.84 4.45 2507.54 4.13
- Interference  
Interference materials such as below the ones in the  Accuracy 
table were added to the test sample(s) the same as the The accuracy was confirmed by 3 different lots testing ten
below concentrations. ichroma™  β-HCG  Plus  test times each different concentration.
results did not show any significant interference with Whole blood type
these materials. β-HCG Lot 1 Lot 2
Interference material Interference (%) [mIU/mL] AVG Recovery AVG Recovery
D-glucose (60mM/L) < 2.5 2000 1972.44 99% 1984.84 99%
L-Ascorbic acid (0.2mM/L) < 3.0 1000 973.37 97% 1008.38 101%
Bilirubin (0.4mM/L) < 2.5 500 499.39 100% 493.16 99%
Hemoglobin (2g/L) < 3.5 50 49.8 100% 50.17 100%
Cholesterol (13mM/L) < 2.5 5 4.97 99% 5.01 100%
Triglyceride (10mg/mL) < 4.0 β-HCG Lot 3
[mIU/mL] AVG Recovery
2000 1980.65 99%
1000 996.52 100%
500 501.57 100%
50 49.03 98%
5 5.11 102%

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Document No. : INS-HC_E-EN
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Serum/Plasma type Note: Please refer to the table below to identify various
β-HCG Lot 1 Lot 2 symbols 
[mIU/mL] AVG Recovery AVG Recovery
2000 1945.16 97% 1999.98 100%
1000 996.93 100% 1012.67 101%
500 496.26 99% 499.81 100%
50 49.35 99% 49.21 98%
5 4.98 100% 4.99 100%
β-HCG Lot 3
[mIU/mL] AVG Recovery
2000 1945.48 97%
1000 1002.8 100%
500 512.99 103%
50 49.18 98%
5 4.99 100%
 Comparability
β-HCG concentrations of 100 serum samples were
quantified independently with ichroma™ β-HCG Plus and
Beckman Coulter Access II System as per prescribed test
procedures. Test results were compared and their
comparability was investigated with linear regression and
coefficient of correlation (R). Linear regression and
coefficient of correlation between the two tests were Y =
0.9401X + 16.591 and R = 0.9881 respectively.
For technical assistance; please contact:
Boditech Med Inc.’s Technical Services
Tel: +(82) -33-243-1400
E-mail: [email protected]

  Boditech Med Incorporated 
43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398
Republic of Korea
Tel: +(82) -33-243-1400
Fax: +(82) -33-243-9373
www.boditech.co.kr

Obelis s.a 
REFERENCES  Bd. Général Wahis 53,1030 Brussels, BELGIUM
1. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopic Tel: +(32) -2-732-59-54
production of human chorionic gonadotropin by Fax: +(32) -2-732-60-03
neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45. E-Mail: [email protected]
2. Steier JA, P Bergsjo, OL Myking “Human chorionic
gonadotropin in maternal plasma after induced abortion,
spontaneous abortion and removed ectopic pregnancy”,
Obstet. Gynecol. 1984; 64(3): 391-394.
3. Lenton EA, LM Neal, R Sulaiman “Plasma concentration of
human chorionic gonadotropin from the time of
implantation until the second week of pregnancy”, Fertil.
Steril. 1982; 37(6): 773-778.
4. Batzer FR. “Hormonal evaluation of early pregnancy”,
Fertil. Steril. 1980; 34(1): 1-13
 

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