Detection principle:
The product uses the double antibody sandwich method and the principle of colloidal gold immunochromatography to qualitatively detect HCG in urine.
Packaging composition:
HCG detection reagent: single serving in aluminum foil bag. add
Sample straws.
Instructions for use.
Sample collection container: clean and pollution-free plastic container, or disposable container, used to collect urine samples.
Timer: used to time the detection.
Sample collection and processing
Urine samples must be collected in clean, dry plastic or glass containers. Urine can be collected at any time of the day. However, the first morning urine of the day usually contains the highest concentration of HCG. The storage time of urine samples frozen at 2°C-8°C does not exceed 72 hours. The temperature of the frozen urine sample should be equilibrated to room temperature before testing.
Detection steps:
The urine specimen and kit must be returned to room temperature (20-30°C) before testing.
1. The kit should be used within 1 hour after tearing; if it is in an environment exceeding 30°C or high humidity, it should be used as soon as possible.
2. Place the kit on a clean and level surface, use the straw in the aluminum foil bag to suck the urine sample, and vertically add 2-3 drops of the sample without bubbles (about 80- 100μl).
3. Wait for the red band to appear. The result is interpreted in 3-5 minutes, and the judgment is invalid after 10 minutes.
Positive: A red line appears at the detection line (T line) and the quality control line (C line) of the result observation window, indicating that HCG is present in the sample.
Negative: Only a red line appears at the position of the quality control line (line C), indicating that there is no HCG in the sample.
Invalid: No red line appears at the position of the quality control line, indicating that the result is invalid and should be tried again.
Matters needing attention:
1. There is no color band on the quality control line and the test line, indicating that a test error should be retryed; when the HCG concentration is high, the test line is obvious, and the control line may become weak, which is a normal result;
2. If the subject is still suspected of being pregnant, and the urine test is negative, the morning urine can be collected again after 48 to 72 hours;
3. Patients with uterine tumors, hydatidiform moles or menopause may have a positive result due to the high content of HCG in the urine
4. The final result should be determined by the clinician's comprehensive analysis of all clinical indexes and laboratory test results.
5. Some immune interference substances, such as those used in antibody therapy, will invalidate the test results.
6. Storage: Store at 4~30℃ and avoid light. Do not freeze. Use within the validity period.
7. Validity period: 24 months