hCG Test
For the presumptive diagnosis of Pregnancy.
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Rapid Immunoassay for the Qualitative Detection of Human Chorionic Gonadotrophin in Urine
Intended Use
hCG-Test is highly sensitive (20 IU/L) and is most suited to testing for the
presumptive diagnosis of pregnancy in departments such as A & E, X-Ray, Gynaecology
and Family Planning clinics. We do not normally recommend such a sensitive test
for 'home testing'.
Summary and Principle of Procedure
Human chorionic gonadotrophin (hCG) is a glycoprotein hormone produced by the
placental trophoblastic cells shortly after the fertilized ovum is implanted in
the uterine wall. 1 - 4 The primary function of hCG is to maintain the corpus
luteum during early pregnancy. The appearance of hCG in the urine soon after
conception and its rapid rise in concentration make it an excellent indicator of
pregnancy. The hormone may become detectable in urine as early as 7 to 10 days
after conception. The concentration of hCG continues to rise rapidly, frequently
exceeding 100 IU/L by the first missed menses and peaking in the 30,000-100,000
IU/L range by 10 to 12 weeks into normal pregnancy.
The hCG-Test - is a solid phase, two-site immunometric assay in which a
combination of monoclonal and polyclonal antibodies is used to selectively
detect elevated levels of hCG in urine with a high degree of sensitivity. In the
test procedure the hCG-Test strip is dipped into the urine specimen for 10
seconds and results are observed at 5 minutes. If hCG is present in the
specimen, it will generate a coloured line.
Storage and Stability
hCG-Test strips should be stored in a dry place at 4°C to 30°C in their original
container. The individual test strips should be kept in the tube until required
for use.
Test Procedure
Simply dip the hCG-Test strip into the specimen for 10 seconds and observe the
appearance of coloured lines on the membrane after 5 minutes have elapsed.
Full details of performance characteristics, specificity, clinical evaluations
and test procedures are contained in the comprehensive instruction sheet
provided in the product pack. Quick reference posters are also available.
| Order Codes | |
| Product | Code |
|---|---|
| hCG tests. 100 test per pack | K2012 |
| hCG tests. 300 test per pack | K2013 |
Note: For Professional in vitro diagnostic use only.
References
1. Braunstein GD, Rasor J, Adler D, Dazer H, Wade ME Serum human chorionic gonadotrophin levels throughout normal
pregnancy. Am J Obstet Gynecol. 1976; 126: 678-681.
2. Kreig AF. Pregnancy Tests and Evaluation of Placental Function. In:
Clinical Diagnosis and Management by Laboratory Methods, 16th ed., Henry
J.B. (ed.) W.B. Saunders Co., Philadelphia, pp. 680, 1979.
3. Brody S, Carlstrom G. Immunoassay of human chorionic gonadotrophin in
normal and pathologic pregnancy. J Clin Endocrinol Metab. 1962;
22: 564-574.
4. Hussa RO. Human chorionic gonadotrophin - a clinical marker: Review
of its biosynthesis. Ligand Review. 1981; 3: 6.