Follicle Stimulating Hormone Test
Catalog Number: A01-04-113 (strip)/ A01-04-130 (midstream)/ A01-04-122 (cassette)
INTENDED USE:
Artron one-step Follicle-stimulating hormone (FSH) Menopause Test is a rapid and convenient immunochromatographic assay used for the qualitative detection of FSH in urine at or above 25 mIU/ml, for early diagnosis of menopause. The device is designed for professional and 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’s one-step FSH Menopause Test is an antigen-capture immunochromatographic assay, that detects the presence of FSH in human urine samples.
Monoclonal antibodies specifically against FSH are 1) conjugated with colloidal gold and deposited on the conjugate pad and 2) immobilized on the test line on the nitrocellulose membrane.
When the urine sample is added the gold-antibody conjugate is rehydrated and the FSH if any in samples, interacts with the gold-conjugated antibodies. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone (T) where they will be captured by immobilized antibodies, forming a visible pink line (Test band, indicate positive results). If FSH is absent in the sample, no pink line will appear in the Test Zone (T), indicating a negative result.
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:
25mIU/mL
Analytical Specificity:
No cross reactions were observed from all tested analytes at the tested highest concentration of 15 IU/L of hHCG, 500 mIU/mL of hLH and 1000 μIU/ml of TSH
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
100%
Diagnostic Specificity:
98.1%
Accuracy:
99.0%
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 in vitro diagnostic use only.
- Do not use after the expiration date shown on the pouch. Do not reuse.
- Do not use if the pouch seal or its packaging is compromised.
- Do not mix and interchange different specimens.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while handling potentially infectious materials or 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 being 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.