Artron Human Chorionic Gonadotropin Serum/Urine Combo Test Kit (POCT USE)
Catalog Number: A01-01-213 (strip)/ A01-01-222 (cassette)
INTENDED USE:
Artron one-step Human Chorionic Gonadotropin (HCG) Test Kit is a rapid and convenient immunochromatographic in vitro assay for the detection of HCG hormone in urine to help in the early diagnosis of pregnancy. The device is designed for self-testing use. The test provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
DESCRIPTION:
Artron one-step HCG Test Kit is an antigen-capture immunochromatographic assay, which detects the presence of HCG in human serum or urine samples. Monoclonal antibodies specifically against HCG (beta or alpha unit) are 1) conjugated with colloidal gold and deposited on the conjugate pad, and 2) immobilized on the test line of the nitrocellulose membrane. When the urine sample is added the gold-antibody conjugate is rehydrated and the HCG if any in samples, interacts with the gold-conjugated antibodies. The antigen-antibody-gold complex will migrate toward the test window until the Test Zone (T) where it will be captured by immobilized antibodies, forming a visible pink line (Test band), indicating a positive result. If HCG is absent in the sample, no pink line will appear in the Test Zone (T), indicating a negative result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. The absence of a pink control line in the Control Zone is an indication of an invalid result.
The detection limit for the A01-01-130 HCG Test Kit is 20 mIU/ml HCG, and for the A01-02-130 HCG test kit (Ultrasensitive) is 10 mIU/ml. Urine samples containing HCG levels equal to or greater than the detection limit will test positive. Samples containing HCG at levels less than the
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. The absence of a pink control line in the Control Zone is an indication of an invalid result.
The detection limit for the A01-01-130 HCG Test Kit is 20 mIU/ml HCG, and for the A01-02-130 HCG test kit (Ultrasensitive) is 10 mIU/ml. Urine samples containing HCG levels equal to or greater than the detection limit will test positive. Samples containing HCG at levels less than the
SAMPLE TYPE:
Time to Results:
10 min (Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes.)
Analytical Sensitivity:
20mIU/mL
Analytical Specificity:
No cross reactions were observed from all tested specimens
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
99.04% (serum), 98.04 (urine)
Diagnostic Specificity:
97.92% (serum), 98.98% (urine)
Accuracy:
98.50% (serum and urine)
Precision
The precision was determined by replicate assays of both positive and negative samples with devices from three different production lots. The resultant data indicated no appreciable between lot variation when testing both positive and negative samples across three different lots.
Storage condition:
Store at 2-30°C, avoid direct sunlight and freezing.
Shelf life:
36 months
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WARNINGS AND PRECAUTIONS
- For professional in vitro diagnostic use only.
- Do not reuse.
- Do not use if the product is sealed barrier or its packaging is compromised.
- Do not use it after the expiration date shown on the pouch.
- Do not mix and interchange different specimens.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while handling potentially infectious material and performing the assay.
- Wash hands thoroughly after finishing the tests.
- Do not eat, drink or smoke in the area where the specimens or kits are handled.
- Clean up spills thoroughly with appropriate disinfectants.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
- Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of hazardous materials should follow local, national, or regional regulations.
- Keep out of children’s reach.