30 405-01 13695 D - en - 2015/07 VIDAS® HCG (HCG)

The VIDAS→ HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative
enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG)
concentration in human serum or plasma to aid in the early detection of pregnancy.
PRINCIPLE OF THE PROCEDURE
The VIDAS→ HCG (HCG) assay is an enzyme-linked
SUMMARY AND EXPLANATION OF THE TEST The fluorescent immunoassay (ELFA) that is performed in an
human Chorionic Gonadotropin (hCG) is a glycoprotein automated instrument. All assay steps and assay
with a molecular weight of 40,000 daltons. Two temperature are controlled by the instrument. A pipette
polypeptide subunits, alpha and beta, form hCG. The hCG tip-like disposable device, the Solid Phase Receptacle
alpha subunit, composed of 92 amino acids, contains the (SPR→), serves as a solid phase for the assay as well as a
amino acid sequence identical to that of the other three pipetting device. The SPR is coated at the time of
glycoprotein hormones: LH, FSH, and TSH. The beta manufacture with mouse monoclonal anti-hCG antibodies.
subunit, composed of 145 amino acids and 5 The VIDAS HCG (HCG) assay configuration prevents
oligosaccharidic groups, contains a unique amino acid nonspecific reactions with the SPR. Reagents for the
sequence which gives biological and immunological assay are located in the sealed Reagent Strips. The
specificity to hCG. sample is transferred into the well containing anti-hCG
The appearance of hCG in serum is evident shortly after antibody conjugated with alkaline phosphatase. The
conception. The level of hCG in serum will steadily sample/conjugate mixture is cycled in and out of the SPR
increase and reach a maximum during the first three and the hCG will bind to antibodies coated on the SPR
months of pregnancy. The level then decreases until the and to the conjugate forming a “sandwich”. Wash steps
th
16 week of pregnancy where it stabilizes until pregnancy remove unbound conjugate.
term. The physiologic function of hCG in pregnancy is to A fluorescent substrate, 4-methylumbelliferyl phosphate,
maintain the gestational body and to foster progesterone is cycled through the SPR. Enzyme remaining on the SPR
and estrogen production during the first three months of wall will catalyze the conversion of the substrate to the
pregnancy. HCG also aids in the differentiation of the fetal fluorescent product 4-methylumbelliferone. The intensity
genital tractus and protects the mother’s immune system of fluorescence is measured by the optical scanner in the
from external attacks. instrument ; it is proportional to the hCG concentration
Quantitative measurement of hCG in serum is widely used present in the sample.
in the early detection and confirmation of pregnancy. When the VIDAS HCG (HCG) assay is completed, the
results are analyzed automatically by the instrument and a
report is printed for each sample.

KIT COMPOSITION (60 tests):

60 HCG Reagent STR Ready to use.

Strips

60 HCG SPRs SPR→ Ready to use. SPRs coated with mouse monoclonal anti-hCG antibodies.
(2 x 30)

HCG Control C1 Reconstitute with 2 mL distilled water. Wait 5 to 10 minutes. Mix. Stable after
(lyophilized) reconstitution for 14 days at 2-8°C or until expiration date on kit at -25 ± 6°C. Five
(1 x 2 mL) freeze/thaw cycles are possible. Human serum* with human hCG and 0.1g/L
sodium merthiolate.
MLE data indicate the confidence interval in mIU/mL ("Control C1 Dose Value
Range").

HCG Calibrator S1 Reconstitute with 2 mL distilled water. Wait 5 to 10 minutes. Mix. Stable after
(lyophilized) reconstitution for 14 days at 2-8°C or until expiration date on kit at -25 ± 6°C. Five
(2 x 2 mL) freeze/thaw cycles are possible. Calf serum with human hCG and 0.1g/L sodium
merthiolate.
MLE data indicate the dose value in mIU/mL (1st IRP 75/537) ("Calibrator (S1) Dose
Value") and the confidence interval in "Relative Fluorescence Value ("Calibrator
(S1) RFV Range).

HCG Diluent R1 Ready to use. Calf serum with 1 g/L sodium azide.
(liquid) (2 x 25
mL)

Specifications for the factory master data required to calibrate the test:
• MLE data (Master Lot Entry) provided in the kit
or
• MLE barcodes printed on the box label.

1 Package Insert provided in the kit provided in the kit or downloadable from www.biomerieux.com/techlib.
* This product has been tested and shown to be negative for HBs antigen, antibodies to HIV1, HIV2 and HCV. However, since no
existing test method can totally guarantee their absence, this product must be treated as potentially infectious. Therefore, usual safety
procedures should be observed when handling.

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VIDAS® HCG (HCG) 13695 D - en - 2015/07
The strip
The strip consists of 10 wells covered with a labeled, foil
The SPR seal. The label comprises a bar code which mainly
indicates the assay code, kit lot number and expiration
The interior of the SPR® is coated during production with
date. The foil of the first well is perforated to facilitate the
monoclonal anti-hCG immunoglobulins (mouse). Each introduction of the sample. The last well of each strip is a
SPR is identified by the “HCG” code. Only remove the cuvette in which the fluorometric reading is performed.
required number of SPRs from the pouch and carefully The wells in the center section of the strip contain the
reseal the pouch after opening. various reagents required for the assay.

Description of the HCG Reagent Strip

Wells Reagents

1 Sample well

2-3-4 Empty wells

5 Conjugate: Mouse monoclonal anti-hCG antibodies conjugated to alkaline

phosphatase with 1 g/L sodium azide (600 µL).

6-7 Wash buffer: Sodium phosphate (0.01 mol/L, pH 7.4) with 1 g/L sodium azide
(600 µL)

8 Wash buffer: diethanolamine DEA* (1.1 mol/L or 11.5%) pH 9.8 + 1 g/L sodium
azide (600 µL).

9 Empty well

10 Reading cuvette with Substrate: 4-methylumbelliferyl phosphate (0.6 mmol/L) +

diethanolamine DEA** (0.62 mol/L or 6.6 %, pH 9.2) + 1 g/L sodium azide (300
µL).

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
H373 : May cause damage to organs through prolonged or repeated exposure.
H315 : Causes skin irritation.
H302 : Harmful if swallowed.
Precautionary statement
P280 :Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
P309 + P311 : IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
** Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
Precautionary statement
P280 :Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.

For further information, refer to the Safety Data Sheet.

• For other specific materials, please refer to the
Instrument Operator’s Manual.
MATERIALS REQUIRED BUT NOT PROVIDED • Pipette • Instrument of the VIDAS family: VIDAS, miniVIDAS or
with disposable tips to dispense 2 mL and 100 µL. VIDAS 3.
• Powderless disposable gloves.

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VIDAS® HCG (HCG) 13695 D - en - 2015/07
• After opening the kit, check that the SPR pouch is
correctly sealed and undamaged. If not, do not use the
WARNINGS AND PRECAUTIONS SPRs.
• Carefully reseal the pouch with the desiccant inside
• For in vitro diagnostic use.
after use to maintain stability of the SPRs and return
• Caution: US Federal Law restricts this device to sale the complete kit to 2-8°C.
by or on the order of a licensed practitioner. • For
• If stored according to the recommended conditions, all
professional use only.
components are stable until the expiration date indicated
• This kit contains products of human origin. No
on the label. Refer to the kit composition table for
known analysis method can totally guarantee the special storage conditions.
absence of transmissible pathogenic agents. It is
SPECIMEN COLLECTION AND PREPARATION
therefore recommended that these products be Acceptable specimens include serum or plasma (with
treated as potentially infectious and handled EDTA or heparin anticoagulant). The use of heat
observing the usual safety precautions (see inactivated sera has not been established for this test - do
Laboratory biosafety manual - WHO - Geneva - latest not heat sera. Samples can be stored at 2-8°C in
edition). stoppered tubes for up to 2 days. If longer storage is
• Consider all patient specimens potentially infectious and required, freeze samples at -25 ± 6 °C. Avoid repeated
observe routine biosafety precautions. Dispose of all cycles of freezing and thawing. If necessary, clarify
used components and other contaminated materials by samples by centrifugation.
acceptable procedures for potentially biohazardous
human blood products.
INSTRUCTIONS FOR USE
• This kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the For complete instructions, see the Operator’s Manual.
animals does not totally guarantee the absence of Reading Master lot data
transmissible pathogenic agents. Before each new lot of reagents is used, enter the
• It is therefore recommended that these products be specifications (or factory master data) into the instrument
treated as potentially infectious and handled observing using the master lot entry (MLE) data.
the usual safety precautions (do not ingest or inhale).
• Do not mix reagents or disposables from different lots. • If this operation is not performed before initiating the
Kit reagents contain 1 g/L sodium azide which could react tests, the instrument will not be able to print results. Note:
with lead or copper plumbing to form explosive metal the master lot data need only be entered once for
azides. If any liquid containing sodium azide is disposed each lot.
of in the plumbing system, drains should be flushed with It is possible to enter MLE data manually or
water to avoid build-up. automatically depending on the instrument (refer to the
• The wash buffer (well 8) contains a harmful agent Operator’s Manual).
(11.5% diethanolamine). Refer to the hazard statements
Calibration
"H" and the precautionary statements "P" above.
• The substrate (well 10) contains an irritant agent (6.6% Calibration, using the calibrator provided in the kit, must
diethanolamine). Refer to the hazard statements "H" be performed each time a new lot of reagents is opened,
and the precautionary statements "P" above. after the master lot data have been entered. Calibration
• Spills should be wiped up thoroughly after treatment with should then be performed every 14 days. This operation
liquid detergent and a solution of household bleach provides instrument-specific calibration curves and
containing at least 0.5 % sodium hypochlorite to compensates for possible minor variations in assay signal
inactivate infectious agents. See the Operator’s Manual throughout the shelf-life of the kit.
for cleaning spills on or in the Instrument. Do not place The calibrator, identified by S1, must be tested in
solutions containing bleach in the autoclave. duplicate (see Operator’s Manual). The calibrator value
• The instrument should be routinely cleaned and must be within the set RFV "Relative Fluorescence Value"
decontaminated. See the Operator’s Manual for the range. If this is not the case, recalibrate.
appropriate procedures. Assay Procedure
1. Remove necessary components from the kit and return
STORAGE AND HANDLING all unused components to storage 2-8°C. 2. Allow
• Store the VIDAS→ HCG (HCG) Kit at 2-8°C. • Do not components to reach room temperature (approximately 30
freeze reagents, with the exception of calibrators and minutes).
controls after reconstitution. • Store all unused
3. Use one "HCG" strip and one "HCG" SPR for each
reagents at 2-8°C.
 sample, control or calibrator to be tested. Make sure pellet).
the storage pouch has been carefully resealed
after the required SPRs have been removed. 7. For this test, the calibrator, control, and sample
test portion is 100 µL.
4. The test is identified by the "HCG" code on the
instrument. The calibrator must be identified by "S1",
and tested in duplicate. If the control is to be tested, it
should be identified by "C1".
8. Insert the “HCG” Reagent Strips and SPRs into the
5. If needed label the “HCG” Reagent Strips with the appropriate position on the instrument. Check to make
appropriate sample identification numbers. sure the color labels with the assay code on the SPRs
6. Mix the Calibrator, Control and sample using a vortex and the Reagent Strips match.
type mixer (for serum or plasma separated from the

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VIDAS® HCG (HCG) 13695 D - en - 2015/07
RESULTS AND INTERPRETATION
9. Initiate the assay processing as directed in the Two instrument readings for fluorescence in the Reagent
Operator’s Manual. All the assay steps are performed Strip’s reading cuvette are taken for each specimen
automatically by the Instrument. tested. The first reading is a background reading of the
cuvette and substrate before the SPR→ is introduced into
10. Reclose the vials and return them to the required
the substrate. The second reading is taken after the
temperature after pipetting.
substrate has been exposed to the enzyme conjugate
11. The assay will be completed within approximately 30 remaining on the interior of the SPR.
minutes. After the assay is completed, remove the The background reading is subtracted from the final
SPRs and strips from the instrument. reading to give a Relative Fluorescence Value (RFV) for
12. Dispose of the used SPRs and strips into an the test result.
appropriate recipient. The acceptable range of results for the VIDAS HCG
(HCG) assay is 2 mIU/mL to 1500 mIU/mL. Samples with
QUALITY CONTROL concentrations greater than 1500 mIU/mL must be diluted
by 1/20 (1 volume of sample and 19 volumes of diluent
A control is included in each VIDAS ® HCG (HCG) kit. This
R1) or 1/200 (1 volume of sample and 199 volumes of
control must be performed immediately after opening a diluent R1) in VIDAS HCG (HCG) diluent R1. If the
new kit to ensure that reagent performance has not been dilution factor has not been entered when the analysis has
altered. Each calibration must also be checked using this been requested (see Operator’s Manual), multiply the
control. The instrument will only be able to check the result by the dilution factor to obtain the hCG sample
control value if it is identified by C1. Results cannot be concentration.
validated if the control value deviates from the expected
A report is printed which records
values.
• the type of test performed,
Note • the sample identification,
It is the responsibility of the user to perform Quality • the date and time,
Control in accordance with any local applicable • the lot number and the expiration date of the reagent kit
regulations. being used,
• each sample’s RFV and hCG concentration

LIMITATION OF THE TEST

Elevated serum hCG levels are seen in patients with certain trophoblastic diseases, as well as in pregnancy. As stated in
the Intended Use, the VIDAS HCG (HCG) assay is only for use to aid in the early detection of pregnancy, not for use in
monitoring tumor activity.

PERFORMANCE DATA
Immunological Specificity
The cross-reactivity percentage is the ratio between the compound concentration to be tested and the hCG concentration
to be tested at signal of 1000 RFV. No cross-reactivity in the VIDAS HCG (HCG) assay was observed with the
substances tested.
Tested Cross
components reactivity
percentage

LH 0.10
(SCRIPPS ref. L0815-lot n°399711)

FSH 0.10
(SCRIPPS ref. F0615-lot n°312711)
 TSH < 0.07
(SCRIPPS ref. T0115-lot n°148911)

hCG free alpha subunit 0.31

(SCRIPPS ref. C0814-lot n°255091)

hCG free beta subunit 2.3

(SCRIPPS ref. C0914-lot n°232812)

hCG 100
(SCRIPPS ref. C0714-lot n°210164)

Immunological interference was tested by adding 10,000 mIU/mL of LH or 12,500 mIU/mL of FSH to a sample containing
1356 mIU/mL of hCG. No interference in the VIDAS HCG (HCG) assay was observed with either of the substances
tested.

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VIDAS® HCG (HCG) 13695 D - en - 2015/07

Detection limit
The detection limit (assay sensitivity) is defined as the lowest concentration that can be distinguished from zero with 95
% probability. The detection limit for the VIDAS HCG (HCG) assay on VIDAS/miniVIDAS is 2 mIU/mL. The detection
limits (Limit of Blank LoB, Limit of Detection LoD, Limit of Quantification LoQ) the VIDAS HCG assay on VIDAS 3 were
evaluated per CLSI EP17-A2 and were: LoB = 0.242 mIU/mL; LoD = 0.571 mIU/mL; LoQ = 1.280 mIU/mL.
Hook Effect
The Hook effect was tested using hCG concentrations up to 400,000 mIU/mL. As seen in the graph below the signal no
longer increases at concentrations greater than 100,000 mIU/mL. However, all concentrations tested between 1,500 and
400,000 mIU/mL produced printouts with the statement “>1,500 mIU/mL OFF CURVE”.

<------------------>
Calibration Range

Linearity – VIDAS 3
Three sample pools were serially diluted into a total of 11 samples in order to evaluate the linearity according to CLSI
EP06-A. The VIDAS HCG assay on VIDAS 3 is linear across the measuring range 2 - 1500 mIU/mL.

PRECISION/REPRODUCIBILITY – VIDAS/MINIVIDAS
Intra-assay reproducibility:
Five samples were tested for intra-assay precision. Thirty replicates of each sample were tested in the same run.
 Sample 1 2 3 4 5

Mean 16.6 71.8 257.0 334.0 1211.0

concentration
mIU/mL)

% CV 6.8 4.3 4.6 4.8 5.4

Inter-assay reproducibility on the same instrument:

Five samples were tested in singlet on the same instrument over a 9 week-period (recalibration was performed every 14
days as described in the Operator’s Manual).
Sample 1 2 3 4 5

Mean 17.4 71.4 253.0 334.0 1152.0

concentration
(mIU/mL)

% CV 8.7 5.1 4.3 4.8 5.0

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VIDAS® HCG (HCG) 13695 D - en - 2015/07

Inter instrument and inter-assay reproducibility:

Five samples were tested in singlet in 8 runs on different instruments.
Sample 1 2 3 4 5

Mean 15.6 71.0 253.0 338.0 1126.0

concentration
(mIU/mL)

% CV 9.4 4.3 5.3 5.7 5.3

PRECISION/REPRODUCIBILITY (VIDAS 3)
Six serum samples were tested in duplicate (2 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using
3 instruments at 1 site (N = 72). The results were calculated according to CLSI EP5-A2 and were as follows:
Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6

N = 72 N = 72 N = 72 N = 72 N = 72 N = 72

Mean Mean Mean Mean Mean Mean

(mIU/mL) (mIU/mL) (mIU/mL) (mIU/mL) (mIU/mL) (mIU/mL)
4.46 6.46 9.48 74.43 311.52 1109.32

SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV

Within-RUN 0.30 6.7 0.35 5.4 0.41 4.4 3.16 4.2 12.4 4.0 56.36 5.1
(Repeatabili 8
ty)

Between 0.08 1.7 0.26 4.1 0.12 1.3 2.36 3.2 5.59 1.8 32.71 2.9
CALIBRATIO
N

Total 0.34 7.6 0.48 7.5 0.54 5.7 4.02 5.4 14.8 4.8 65.16 5.9
Between 4
INSTRUME
NT

Three samples were diluted in VIDAS HCG (HCG) diluent and tested in singlet in 3 runs.
 Sample Dilution Expected values Measured values Recovery
factor (mIU/mL) (mIU/mL) percentage

1/1 239.0 239.0 100.0

1/2 119.5 120.3 100.0
1 1/4 59.8 59.2 99.0
1/8 29.9 28.5 96.0
1/16 15.0 14.0 94.0
1/32 7.5 6.2 83.0

1/1 329.0 329.0 100.0

1/2 164.8 163.7 99.0
2 1/4 82.4 77.8 94.0
1/8 41.2 39.2 95.0
1/16 20.6 19.1 93.0
1/32 10.3 8.4 81.0

1/1 1102.0 1102.0 100.0

1/2 551.0 565.0 102.0
3 1/4 275.5 279.0 101.0
1/8 137.8 139.0 101.0
1/16 68.9 71.6 104.0
1/32 34.4 34.0 99.0

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VIDAS® HCG (HCG) 13695 D - en - 2015/07

Dilution – VIDAS 3
Four samples (human serum pool) were tested on two VIDAS 3 systems using an automated dilution sequence and a
manual dilution sequence. The average relative difference between the observed HCG concentration (automatic testing)
and the estimated theoretical HCG concentration (manual testing) was estimated as: Relative diff. (%) = 100 X
(Observed dose – Theoretical dose) / Theoretical dose. The global average relative difference observed per dilution ratio
ranged from -3.1% to +9.4%.
Carry-over – VIDAS 3
One high HCG positive sample was tested with one HCG negative sample and one carry-over sample. The average
concentration carry-over observed on VIDAS 3 and its 95% confidence interval were calculated and determined to be
<0.5 PPM (parts per million).

RECOVERY TESTS
Three samples were spiked with known quantities of hCG and tested in singlet in 3 runs. The measured mean
concentration compared to the expected mean concentration is shown below.
Sample Amount Spiked Expected mean Measured mean Mean recovery
(mIU/mL) concentration (mIU/mL) concentration (mIU/mL) percentage

0 69.4 69.4 100.0

10.0 79.4 77.4 97.5
1 56.4 125.8 112.1 89.1
103.0 172.4 169.9 98.3
585.0 654.4 647.6 98.9
1308.0 1377.4 1230.0 89.3

0 247.0 247.0 100.0

10.0 257.0 263.0 102.3
2 56.4 303.0 293.0 96.7
103.0 350.0 361.0 103.0
585.0 832.0 849.0 102.0
 1308.0 > 1500.0 1441.0 -----

0 336.0 336.0 100.0

10.0 346.0 342.0 98.8
3 56.4 392.4 440.0 112.1
103.0 439.0 430.0 97.9
585.0 921.0 932.0 101.2
1308.0 > 1500.0 > 1500.0 -----

INFLUENCE OF SPECIMEN COLLECTION

Blood samples were collected from thirty patients. For each patient, 5 specimens were collected at the same time: in a
tube with beads; in a dry glass tube; in a tube with separating gel; in a heparinized tube; and in an EDTA tube. Each
sample collected was tested in duplicate and sera from the same donor were tested in the same run. The tube with
beads was the reference to which the other methods were compared.
Collection tube Equation of the line Correlation coefficient

Dry glass tube y = 0.95 ref. + 2.34 0.97

Tube with EDTA y = 0.97 ref. - 0.92 0.99

Tube with heparin (lithium) y = 0.96 ref. + 0.54 0.99

Tube with separating gel y = 1.10 ref. - 1.54 0.99

There are no significant differences between the 5 methods of collection.

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VIDAS® HCG (HCG) 13695 D - en - 2015/07

INTERFERENCE STUDIES
Heparin
Three pools of human sera were spiked with increasing quantities of heparin.
Amount of heparin spiked (U/mL)

0 0.5 5 50

hCG Pool 1 14.8 14.5 14.4 14.0

(mIU/mL)
Pool 2 233.0 232.0 244.0 247.0

Pool 3 1071.0 1025.0 1039.0 1014.0

EDTA
Three pools of human sera were spiked with increasing quantities of EDTA.
Amount of EDTA spiked (mg/mL)

0 1 5 10
 hCG Pool 1 14.8 15.9 13.6 14.3
(mIU/mL)
Pool 2 233.0 251.0 239.0 236.0

Pool 3 1071.0 1068.0 1029.0 1028.0

This data indicates that EDTA or heparin plasma can be used in the VIDAS HCG (HCG) assay.
Hemoglobin
Three pools of human sera were spiked with increasing quantities of hemoglobin obtained from a lysate of human red
blood cells.
Amount of hemoglobin spiked (umol/l)

0 15 30 60 150 210 300

hCG Pool 1 17.0 16.8 18.4 18.8 17.7 17.3 16.5

(mIU/mL) Pool 2
221.0 232.0 235.0 228.0 234.0 231.0 237.0
Pool 3
984.0 1050.0 967.0 1054.0 1015.0 1045.0 1023.0

Turbidity
Three pools of human sera were spiked with increasing quantities of a lipid solution.
Amount of triglycerides spiked (mmol/l)

0 1.0 2.6 3.0 5.0

hCG Pool 1 16.5 16.4 16.4 17.3 16.7

(mIU/mL) Pool 2
254.0 240.0 240.0 240.0 233.0
Pool 3
1029.0 1112.0 1026.0 1072.0 1021.0

Appearance Clear Opalescent Turbid

Bilirubin
Three pools of human sera were spiked with increasing quantities of bilirubin.
Amount of bilirubin spiked (µmol/l)

0 25.6 51.3 102.6 256 385 513

hCG Pool 1 16.3 16.4 16.0 16.4 15.4 17.0 16.9

(mIU/mL) Pool 2
227.0 228.0 234.0 233.0 234.0 229.0 241.0
Pool 3
983.0 1062.0 984.0 1071.0 1043.0 1032.0 1023.0

Although interference linked to the presence of hemoglobin, bilirubin or turbidity has not been observed, using
hemolyzed, icteric or lipemic samples is not recommended. If possible, collect a new specimen.

8
 VIDAS® HCG (HCG) 13695 D - en - 2015/07

nt
EXPECTED VALUES
113 0.9265 0.0828 0.9848
The results are given mIU/mL (1st IRP 75/537). Among a
[0.9043, [-0.1242, [0.9779,
population of healthy people, and not infected with
0.9488] 0.2898] 0.9895]
tumorous pathologies; the following values have been
found:
Population: N= Normal Range:
WASTE DISPOSAL
- women 204 < 5 mIU/mL
Dispose of used or unused reagents as well as any other
contaminated disposable materials following procedures
-menopausal 268 < 10 mIU/mL
for infectious or potentially infectious products. It is the
women
responsibility of each laboratory to handle waste and
effluents produced according to their nature and degree of
hazardousness and to treat and dispose of them (or have
them treated and disposed of) in accordance with any
It is advisable for each laboratory to establish its own applicable regulations.
expected values on a well-defined population.

CORRELATION – VIDAS/MINIVIDAS LITERATURE REFERENCES

One hundred ninety-one specimens were tested at a 1. FEINSTEIN M.C., AKAR A., BLACKER C., LAHLOU N.,
clinical chemistry laboratory. Samples with hCG PERNOT P., WEIZANI H. “hCG et ses sous-unités comme
concentrations ranging from 0 mIU/mL to 80,000 mIU/mL marqueurs tumoraux”. J. Steroid. Biochem. 1989, 33, n°4B,
7716775.
were tested using the VIDAS→ HCG (HCG) assay and a
commercially available quantitative hCG EIA. A summary 2. NORMAN R.J., BUCK R. H., DEMEDEIROS S.F.,
of the results is shown below. “Measurement of human chorionic gonadotrophin (hCG):
indications and techniques for the clinical laboratory. Ann.
# of Slope Intercept Correlation Clin. Biochem., 1990, 27, 183-194.
Samples coefficient 3. ODELL W.D., GRIFFIN J. “Pulsatile secretion of chorionic
gonadotropin during the normal menstrual cycle”. J. Clin.
191 1.092 208.87 0.99 Endocrinol. Met., 1989, 69, 528-532.
4. OZTURK M. et al. “Physiological studies of human chorionic
gonadotropin (hCG) aHCG and bHCG as measured by
specific monoclonal immunodiametric assays”. Endocrinol.,
1987, 120, 549-558.
CORRELATION – VIDAS 3
5. PIERCE J. G., PARSONS T.F. “Glycoprotein hormones :
A study was conducted to verify the correlation of the structure and function”. Ann. Rev. Biochem., 1981, 50, 465-
VIDAS HCG assay on the VIDAS 3 to the VIDAS HCG 495.
assay on the VIDAS. One reagent lot, one of each
6. SCHOLLER R. “Surveillance hormonale de la grossesse”.
instrument and 113 serum samples were used. The Encycl., Med., Chir., paris, Obstétrique, 5015 A 10, 11-1980.
results were evaluated according to CLSI EP9, 95%
Confidence Intervals (CI) were calculated, and were as 7. SCHOLLER R., GERNASY G., AVIBDOR R., CASTANIER M.
“Colloque sur les actualités en immunoanalyse”. Ed.
follows:
Bergeret, 1987, 225-233. Bordeaux. 2-4 décembre 1987.
# of Slope Intercept Correlati 8. WASS M., MITCHELL D.C., BAGSHAWE K.D. “Human
Samples on chorionic gonadotrophin”. In hormones in blood (edited by
C.H. GRAY and V.H.T JAMES), Academic Press, 3rd edition
coefficie
(1983), 179-193.
 9
VIDAS® HCG (HCG) 13695 D - en - 2015/07

INDEX OF SYMBOLS
Symbol Meaning

Catalog number

In Vitro Diagnostic Medical Device

Caution: US Federal Law restricts

this device to sale by or on the
order of a licensed practitioner

Manufacturer

Temperature limit

Use by date

Batch code
 Consult Instructions for Use

Contains sufficient for <n> tests

Date of manufacture

WARRANTY
bioMérieux, Inc. disclaims all warranties, express or implied, including any implied warranties of MERCHANTABILITY
AND FITNESS FOR A PARTICULAR USE. bioMérieux shall not be liable for any incidental or consequential damages.
IN NO EVENT SHALL BIOMERIEUX’S LIABILITY TO CUSTOMER UNDER ANY CLAIM EXCEED A REFUND OF THE
AMOUNT PAID TO BIOMERIEUX FOR THE PRODUCT OR SERVICE WHICH IS THE SUBJECT OF THE CLAIM.

REVISION HISTORY
Change type categories :
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the revision history.
Release Part Number Change Type Change Summary
date

2015/07 13695D Administrative INDEX OF SYMBOLS

REVISION HISTORY

Technical KIT COMPOSITION (60 tests)

MATERIALS REQUIRED BUT NOT
PROVIDED WARNINGS AND
PRECAUTIONS
LIMITATION OF THE TEST
PERFORMANCE DATA

BIOMERIEUX, the blue logo, SPR and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux or one of its
subsidiaries, or one of its companies.
Any other name or trademark is the property of its respective owner.

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