One Step FSH MENOPAUSE Test Device for detection of
Follicle-Stimulating Hormone (FSH) urine test, easily use
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 device to room temperature(15-30℃) prior
to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat,
clean and dry surface.
3. Use the provided pipette to withdraw urine specimen from the
urine cup and dispense 3 drops into the sample well.
4. Wait for pink-colored lines to appear. Read results within 5
minutes. Do not read results after 5 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
| Method | Other FSH Rapid Test | Total Results |
FSH One Step Test Strip | Results | Positive | Negative |
| Positive | 53 | 3 | 56 |
| Negative | 0 | 129 | 129 |
| Total Results | 53 | 132 | 185 |
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.
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
