This one Step HCG Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
SUMMARY AND EXPLANATION
Human Chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. During normal pregnancy, HCG can be detected in urine as early as 7 days following conception, doubling every 1.3 to 2 days. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml seen at the end of the first trimester. The presence of HCG soon after conception and its subsequent increase in concentration during early gestational growth make it an ideal marker for the early detection of pregnancy.
The One Step HCG Pregnancy Test is a rapid qualitative one-step assay for the detection of HCG in the urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, the level of HCG as low as 25mlU/ml can be detected.
As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex. This complex binds to the anti-HCG antibody in the positive reaction zone (“T” area) and produces a pink-purple coloured band when the HCG concentration is greater than 25mlIU/ml. In the absence of HCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone (“C” area), producing a pink-purple band, demonstrating that the reagents are functioning properly
One HCG pregnancy test midstream per foil pouch.
Ingredients: Test device comprised colloidal gold-coated with anti β hCG antibody,
nitrocellulose membrane pre-coated goat anti-mouse IgG and mouse anti α hCG
Each box contains:
- 2 Sets of One Step HCG Pregnancy Test midstream
STORAGE AND STABILITY
Store test at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.
1. SPECIMEN COLLECTION AND HANDLING
The One Step HCG Pregnancy Test is formulated for use with fresh urine specimens only. Urine cup can also be used to collect specimens, and the urine does not require any special pretreatment.
2. TEST PROCEDURE
1) Remove the test stick from the foil pouch
2) Remove the cap to expose the absorbent tip
3) Hold the stick by the thumb grip with the exposed absorbent tip pointing downward. Urinate on the absorbent tip only until it is thoroughly wet.
4) Lay the test stick down on a flat surface with the windows on top while you wait for the test result. Read the result in one to five minutes.
DO NOT INTERPRET RESULT AFTER 5 MINUTES.
5) Discard the test device after a single use in a dustbin.
3. INTERPRETATION OF RESULTS
If only one pink line appears in the control area, you can assume that you are not pregnant.
If two pink lines appear both in the control area and test area, you can assume that you are pregnant.
IF there is no distinct pink-purple coloured band visible both in the TEST area and CONTROL area, or only a pink-purple coloured band visible in Test area, the test is invalid. It is recommended that in this case the test be repeated.
After adding the sample, these coloured bands migrate along the membrane at the leading edge of the dye conjugate and are “removed” from the test completely.
When the test is complete, you will see a pink-purple coloured band in the “C” area of the test strip on negative samples and a pink-purple coloured band in the “T” and “C” area on positive samples. The appearance of the CONTROL band indicates that the test is performing properly and serves as procedural control.
1. ANALYTICAL SENSITIVITY & DIAGNOSTIC SENSITIVITY
Use the three transfer lots to test the standard solution with concentration as 0mIU/ml, 10mIU/ml,25mIU/ml, 50mIU/ml100mIU/ml, and each concentration have tests three times. Read results within 5 minutes.
According to the test results, One Step HCG Pregnancy Test had shown the positive results at the concentration of 25mIU/ml, so the sensitivity of the test is 25mIU/ml.
Random urine specimens were received and tested for pregnancy using One Step HCG Pregnancy Test and Egens HCG Test
Samples were random samples collected at various times throughout the day. Comparing test from One Step HCG Pregnancy Test with Egens HCG Test
A total of 160 urine samples were collected in the hospital, with 90 positive. No discrepancies were observed. One Step HCG Pregnancy Test demonstrates 100% accuracy when compared with the Egens HCG Test.
Use three lots of devices to confirm the reproducibility of the device in three different places, and by three different people.
According to the test results, three lots One Step HCG Pregnancy Test devices had good reproducibility.
Use three lots devices to confirm the variability of the device, to test HCG at the point time on the a.m. and p.m. in each day, each solution had test 5 times, and read results within 5 minutes.
According to the test results, three transfer lots device had a good variability, and the device performance had shown the stable states.
1) Use the three transfer lots to demonstrate that if One Step HCG Pregnancy Test has cross-reaction with commonly encountered substances in the urine. All the results were read within 5 minutes.
Urine specimens from 20 postmenopausal women were tested by One Step HCG Pregnancy Test. Then the urine samples were spiked with hCG to give the final concentration of 25 mIU/ml. Samples were tested using the One Step HCG Pregnancy Test.
Midstream tested by urine sample with HCG standard sample should be positive; tested by urine sample without HCG sample should be negative. Otherwise, it means the menopausal urine will interfere with the performance of One Step HCG Pregnancy Test.
All samples were tested with One Step HCG Pregnancy Test. No interference was observed. The results demonstrate that One Step HCG Pregnancy Test has no significant cross-reaction with menopausal women ’s urine.