HCG Test One Step Pregnancy Test Strip

Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. One Step hCG Pregnancy Urine Test is a rapid pregnancy test. It adopts double antibody sandwich method detects the presence of human chorionic gonadotropin (hCG), which appears in urine very early during pregnancy.

Pregancy test kits and specimens should be brought to room temperature(20-30°C) prior to testing One-step HCG test is designed by sandwich principle for detection of hcg in urine. The test owned characteristics of 25 miu/ml sensitivity, specifity, speedy and simplicity
Characteristic:

1. Early detection of pregnancy as early as 7 days after the fertilized egg implantation
2. Simple to use
3. A variety of design specifications suitable for self-testing use and for professional use
4. Results in 3 to 5 minutes
5. Store in room temperature
6. 24 months shelf life
7. Specimen: urine,serum/urine

Specimen Collection

Any urine specimen is appropriate for HCG testing, but the first morning urine is optiomal because it generally contains the highest concentration of HCG. Urine specimens may be collected in any clean and dry container which be stored in the refrigerator(4-8°C) for up to 72 hours before assay if it can not be tested immediately. The stored specimens should be allowed to reach room temperature before testing

Procedure

Test strips and specimens should be brought to room temperature(20-30°C) prior to testing

1. Open the kit,hold the strip at the end without arrow or colored sign
2. Inserted the end with arrow or colored sign of the strip into the urine sample figure 1,waiting for only 3 seconds. Do not immerse the strip into the urine sample over the signed band!
3. Take the strip out and lay the strip flat on a clean, dry and nonabsorbent surface
4. Wait for 1 to 5 minutes and read the results as showed in figure 2

Performance:

1. Sensitivity:25 mIU/ml, 20 mIU/ml, 10 mIU/ml
2. Specificity:No cross-reactivity with 300 mIU/ml hLH, 300 mIU/ml hFSH, and 1000 mIU/L hTSH 

 Standard of Interpretation

• Negative:only one purple band appears on the control region and no clear band on the test region. It means hcg in the sample is negative
• Positive: two distinct purple bands appear on the control and test region. It means hcg in the sample is positive
• Weak positive: the red color band in the test region of strip shows dimmer than the purple color band in the control region of strip. It means it is necessary that test be done again in the 48 hours
• Strong positive: the red color band in the test region of strip show very bright and the purple color band very dim in the control region of strip. It means the pregnancy is developing in the end of the first trimester.
• Invalid: no visible red at all, it means the test is fail