AMH Rapid Test Cassette with Whole Blood/Serum/Plasma for Ovarian Function

A rapid test for the qualitative detection of Methcathinone in human urine CE certified

Applications:

The AMH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of the anti-Mullerian Hormone in whole blood, serum or plasma to aid in the diagnosis of ovarian functions.

Description:

Anti-Mullerian hormone (AMH) has become the ‘molecule of the moment’ in the field of reproductive endocrinology. Serum AMH concentrations show a progressive decline with female ageing. Indeed, it is valuable as a means of increasing understanding of ovarian pathophysiology and for guiding clinical management across a broad range of conditions. AMH is an effective measure of ovarian reserve and it can predict ovarian response to controlled stimulation for women. The clinical pregnancy rate tends to increase as AMH increases.The serum AMH level is an accurate marker of the ovarian early antral follicle number and offers a good diagnostic potency. In situations where accurate ultrasonographic data are not available, AMH could thus be used instead of the follicle count as a diagnostic criterionandin corporated as such in the Rotterdam definition of PCOS.

PRINCIPLE:

The AMH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a semi-quantitative membrane based immunoassay for the detection of anti-Mullerian Hormone in whole blood, serum or plasma. In this test procedure, anti-AMH antibodies is immobilized in the test line region of the test. After specimen is added to the specimen well of the cassette, it reacts with anti-AMH antibody coated colloid gold particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized anti-AMH antibodies. If the specimen contains AMH, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain AMH, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 80 L) to the specimen well (S), then add 1 drop of buffer (approximately 40 L), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 L) to the specimen well (S), then add 1 drop of buffer (approximately 40 L), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 80 L of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40 L) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes by comparing the T line intensity with provided color card. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS
(Please refer to the illustration and compare the T line intensity with “AMH Color Card” provided with the kit.)

Normal: Two colored lines appear. One is in the control region (C) and another should be in the testregion (T). The line intensity in the test region (T) is darker than the 1ng/mL line and lighter than 7ng/mL line depicted on Color card provided with the kit.

Abnormal:
Indicative of lower ovarian reserve: One colored line appears in the control region (C). No apparent colored line appears in the test region (T). Indicative of PCOS: Two colored lines appear, one is in the control region (C) and another should be in the test region (T). The line intensity in region (T) is darker than the 7ng/mL line depicted on the Color card.
Note: Always compare the T line intensity with “AMH Color Card” and interpret results accordingly.
INVALID: Control line fails to appear. 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.