Performance Characteristics - QuickVue+ One-Step hCG Combo Bedienungsanleitung

 Patients with trophoblastic and nontrophoblastic disease
may have elevated hCG levels, therefore, the possibility of
hCG secreting neoplasms should be eliminated prior to the
diagnosis of pregnancy. 4
 If a urine sample is too dilute, it may not contain a representative
urinary hCG concentration. If a negative result is obtained and
pregnancy is still suspected, a first morning sample should be
obtained and tested.
expected valUes
The sensitivity of QuickVue+ One-Step hCG Combo test is
10 mIU/mL for serum or 20 mIU/mL for urine (WHO 3rd IS 75/537).
In normal pregnancy, hCG levels in urine can reach 25 mIU/mL as
early as 7 to 10 days post conception, and continue to increase
exponentially to reach a maximum concentration in excess of
200,000 mIU/mL at the end of the first trimester.

performance characterIstIcs

Clinical Sensitivity, Specificity, and Accuracy
The clinical sensitivity, specificity and accuracy of the QuickVue+
One-Step hCG Combo test was determined by evaluating 497
urine samples and 1528 serum samples obtained from women
presenting for pregnancy testing. Testing was performed by clinic
personnel. Results were compared to results obtained with the
Abbott TestPack® Plus hCG-Combo. A commercially available
quantitative method was used to resolve any discrepant results.
The results are summarized below. Of the 497 urine samples
tested, the QuickVue+ One-Step hCG Combo test yielded an
accuracy of >99%.
Similarly, of the 1528 serum samples tested, the QuickVue+ One-
Step hCG Combo test yielded an accuracy of >99%.
+
quickvue+ one-step
hcg combo test
–
Sensitivity:
Specificity:
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quickvue+ one-step
hcg combo test
–
Sensitivity:
Specificity:
physician's office laboratory (pol) studies
An evaluation of the QuickVue+ One-Step hCG Combo test was
conducted at three Physicians' Offices using a panel of coded
specimens. Testing was performed by physician's office personnel
with diverse educational backgrounds and work experience at
different locations. The proficiency panel contained negative, low
positive and moderate positive samples. Each level was tested in
replicates of five at each site over a period of three days.
The results at each site agreed 100% with the expected results.
No significant differences were observed within run, between
runs, or between sites.
Cross-Reactivity
hTSH, hLH, and hFSH were tested in the QuickVue+ One-Step hCG
Combo test at levels ranging from 1000 µIU/mL to 1000 mIU/mL
and did not affect the expected results.
Interference Testing
The following chemical and biological compounds were tested in
the QuickVue+ One-Step hCG Combo test and did not affect the
expected results.
Urine analytes
Albumin (serum)
Bilirubin
Hemoglobin
Glucose
Urine pH
hormones
LH
FSH
TSH
Estriol 17-beta
Pregnanediol
bacteria
E. coli
Group B Streptococcus
Chlamydia trachomatis
chemical analytes
Acetominophen
Acetoacetic Acid
Ascorbic Acid
β-Hydroxybutyrate
Caffeine
Clomiphene
Gentisic Acid
Salicylic Acid
EDTA
Cannabinol
Cocaine
5
serum correlation
testpack plus hcg combo
+ –
510 6
0 1012
510/510= >99%
1012/1018= >99%
Accuracy:
1522/1528= >99%
Urine correlation
testpack plus hcg combo
+ –
269 0
0 228
269/269= >99%
228/228= >99%
Accuracy: 497/497= >99%
concentration
2000 mg/dL
1000 µg/dL
1000 µg/dL
2000 mg/dL
5–9
concentration
300 mIU/mL
1000 mIU/mL
1000 µIU/mL
1400 µg/dL
1500 µg/dL
concentration
10 CFU/mL
8
2.5 x 10 CFU/mL
7
10 IFU/mL
7
concentration
20 mg/dL
2000 mg/dL
20 mg/dL
2000 mg/dL
20 mg/dL
100 mg/dL
20 mg/dL
20 mg/dL
80 mg/dL
10 mg/dL
10 mg/dL
chemical analytes
Codeine
Heroin
Methadone
Methamphetamine
Methanol
Ephedrine
Phenylpropanolamine
Theophylline
Acetylsalicylic Acid
Benzoylecgonine (cocaine metabolite)
Ethanol
DMSO
Uric Acid
Heparin
assIstance
If you have any questions regarding the use of this product,
please call Quidel's Technical Support number, (800) 874-1517
(toll-free in the U.S.A.) or (858) 552-1100, Monday through
Friday, between 7:00 a.m. and 5:00 p.m. Pacific Time, U.S.A.
If outside the United States, contact your local distributor or
technicalsupport@quidel.com.
references
1. Biosafety in Microbiological and Biomedical Laboratories,
4th Edition. U.S. Department of Health and Human Services,
CDC, NIH, Washington, DC (1999).
2. Rasor J.L. and Braunstein G.D., Obstet. Gynecol., 50, 553–558
(1977).
3. Edmonds D.K., Lindsay K.S., Miller J.F., Williamson E. and
Wood R.J., Fertility and Sterility, 38, 447–453 (1982).
4. Braunstein G.D., Vaitukaitis J.L., Carbone P.P., and Ross G.T.,
Ann. Intern. Med., 78, 39–45 (1973).
5. Lenton E.A., Neal L.M., and Sulaiman R., Fertility and Sterility,
37, 773–778 (1982).
00178 – QuickVue+ One-Step hCG Combo 30 Test Kit
00179 – QuickVue+ One-Step hCG Combo 90 Test Kit
00272 – hCG Control Set
00281 – hCG Serum Control Set
MDSS GmbH
Schiffgraben 41
30175 Hannover,
Germany
quidel corporation
Worldwide Headquarters
10165 McKellar Court
San Diego, CA 92121 USA
www.quidel.com
Authorized Representative in
the European Community
Use by
Batch code
Manufacturer
concentration
10 mg/dL
1 mg/dL
10 mg/dL
10 mg/dL
10.0%
20 mg/dL
20 mg/dL
20 mg/dL
20 mg/dL
10 mg/dL
1.0%
5.0%
20 mg/dL
2800 units/dL
0436405 (02/11)
Catalogue number
Consult instructions for use
For in vitro diagnostic use
Temperature limitation