For the presumptive diagnosis of Pregnancy.

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 Principal 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. 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.