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Package Insert 13695 - HCG D - en - 30405-01 PDF
Package Insert 13695 - HCG D - en - 30405-01 PDF
* 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
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.
MATERIALS REQUIRED BUT NOT PROVIDED • For other specific materials, please refer to the
• Pipette with disposable tips to dispense 2 mL and Instrument Operator’s Manual.
100 µL. • Instrument of the VIDAS family: VIDAS, miniVIDAS or
• Powderless disposable gloves. VIDAS 3.
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VIDAS HCG (HCG) 13695 D - en - 2015/07
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VIDAS HCG (HCG) 13695 D - en - 2015/07
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.
Cross-
Tested
reactivity
components
percentage
LH
(SCRIPPS ref. L0815-lot n°399711) 0.10
FSH
(SCRIPPS ref. F0615-lot n°312711) 0.10
TSH
(SCRIPPS ref. T0115-lot n°148911) < 0.07
hCG free alpha subunit
(SCRIPPS ref. C0814-lot n°255091) 0.31
hCG free beta subunit
(SCRIPPS ref. C0914-lot n°232812) 2.3
hCG
(SCRIPPS ref. C0714-lot n°210164) 100
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
concentration 16.6 71.8 257.0 334.0 1211.0
mIU/mL)
% CV 6.8 4.3 4.6 4.8 5.4
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VIDAS HCG (HCG) 13695 D - en - 2015/07
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:
Three samples were diluted in VIDAS HCG (HCG) diluent and tested in singlet in 3 runs.
Dilution Expected values Measured values Recovery
Sample
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.
Amount Spiked Expected mean Measured mean Mean recovery
Sample
(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 -----
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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.
Bilirubin
Three pools of human sera were spiked with increasing quantities of bilirubin.
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VIDAS HCG (HCG) 13695 D - en - 2015/07
EXPECTED VALUES
The results are given mIU/mL (1st IRP 75/537). Among a
population of healthy people, and not infected with LITERATURE REFERENCES
tumorous pathologies; the following values have been 1. FEINSTEIN M.C., AKAR A., BLACKER C., LAHLOU N.,
found: PERNOT P., WEIZANI H. “hCG et ses sous-unités comme
marqueurs tumoraux”. J. Steroid. Biochem. 1989, 33, n°4B,
Population: N= Normal Range: 7716775.
- women 204 < 5 mIU/mL 2. NORMAN R.J., BUCK R. H., DEMEDEIROS S.F.,
“Measurement of human chorionic gonadotrophin (hCG):
-menopausal indications and techniques for the clinical laboratory. Ann.
268 < 10 mIU/mL
women Clin. Biochem., 1990, 27, 183-194.
3. ODELL W.D., GRIFFIN J. “Pulsatile secretion of chorionic
It is advisable for each laboratory to establish its own gonadotropin during the normal menstrual cycle”. J. Clin.
expected values on a well-defined population. Endocrinol. Met., 1989, 69, 528-532.
4. OZTURK M. et al. “Physiological studies of human chorionic
CORRELATION – VIDAS/MINIVIDAS gonadotropin (hCG) aHCG and bHCG as measured by
specific monoclonal immunodiametric assays”. Endocrinol.,
One hundred ninety-one specimens were tested at a 1987, 120, 549-558.
clinical chemistry laboratory. Samples with hCG
5. PIERCE J. G., PARSONS T.F. “Glycoprotein hormones :
concentrations ranging from 0 mIU/mL to 80,000 mIU/mL structure and function”. Ann. Rev. Biochem., 1981, 50, 465-
were tested using the VIDAS® HCG (HCG) assay and a 495.
commercially available quantitative hCG EIA. A summary 6. SCHOLLER R. “Surveillance hormonale de la grossesse”.
of the results is shown below. Encycl., Med., Chir., paris, Obstétrique, 5015 A 10, 11-1980.
# of Correlation
Slope Intercept
Samples coefficient
113 0.9265 0.0828 0.9848
[0.9043, [-0.1242, [0.9779,
0.9488] 0.2898] 0.9895]
WASTE DISPOSAL
Dispose of used or unused reagents as well as any other
contaminated disposable materials following procedures
for infectious or potentially infectious products.
It is the 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 applicable regulations.
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VIDAS HCG (HCG) 13695 D - en - 2015/07
INDEX OF SYMBOLS
Symbol Meaning
Catalog number
Manufacturer
Temperature limit
Use by date
Batch code
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.
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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