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One Step FSH MENOPAUSE Test Strip for detection of Follicle-Stimulating Hormone (FSH) in urine Gold Colloidal method

INTENDED USE:

The FSH One Step Menopause Test Strip (Urine) is a rapid lateral flow chromatographic immunoassay for the qualitative detection of Follicle-Stimulating Hormone (FSH) level in urine to evaluate the onset of menopause in women.

TEST PRINCIPLE

The FSH One Step Menopause Test Strip (Urine) is a qualitative, lateral flow immunoassay for the qualitative detection of human Follicle-Stimulating Hormone in urine to evaluate the onset of menopause in women. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate.

Positive specimens react with the specific antibody-FSH-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE
1. Bring the pouched test strip to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Immerse the test strip in the urine specimen for at least 5 seconds with the arrow end pointing toward the urine. Do not immerse the strip above the printed MAX line.
4. Remove the test strip from the urine and lay flat on a non-absorptive clean surface. Or leave the test strip in the urine specimen as long as the strip is not immersed above the MAX line.
5. Wait for pink-colored lines to appear. Read result within 3-8 minutes. Do not read result after 10 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two distinct colored lines are visible, and the line in the test line region (T) is the same as or darker than the line in the control line region (C). A positive result indicates that the FSH level is higher than normal and the subject may be experiencing perimenopause.

NEGATIVE: Two colored lines are visible, but the line in the test line region (T) is lighter than the line in the control line region (C), or there is no line in the test line region (T). A negative result indicates that the subject is probably not experiencing perimenopause in this cycle.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect test performance are the most likely reasons for an invalid result. Review the procedure and repeat with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Performance

A multi-center clinical evaluation was conducted comparing results obtained using the FSH One Step Menopause Test Strip (Urine) to another commercially available urine membrane FSH test. The study included 200 urine specimens, and both assays identified 120 negative and 78 positive results. The results demonstrated 99% accuracy of the FSH One Step Menopause Test Strip (Urine) when compared to the other urine membrane FSH test.

FSH One Step Test Strip vs. Other FSH Rapid Test

Relative Sensitivity: 100.0% (93.3%-100.0%)*

Relative Specificity: 97.7% (93.5%-99.5%)*

Relative Accuracy: 98.4% (95.3%-99.7%)*

* 95% Confidence Intervals

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most

likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, please contact your local distributor.