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Quantitative AMH Test Cassette for Fluorescence Immunoassay of Ovarian Reserve Function

Brand Name:	ALLTEST Novatrend Plus
Model Number:	FI-AMH-402
MOQ:	N/A
Price:	negotiation

Detail Information

Product Description

Detail Information

Assay Time:

15 Minutes

Shelf Time:

24months

Storage Temperature:

4-30℃

Sample Type:

Whole Blood/serum/plasma

Accuracy:

High

Pack:

10T/25T

Format:

Cassette

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Product Description

AMH Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence Immunoassay

for the quantitative determination of Antimullerian hormone in whole blood,serum,plasma

by using Novatrend Plus fluorescence immunoassay analyzer, and it is mainly used for

assessing ovarian reserve function, menopause and polycystic ovary syndrome (PCOS).

The AMH Test Cassette(Whole blood/Serum/Plasma) is intended for in vitro quantitative

determination human antimullerian hormone in human whole blood/serum/plasma as a

measure of certain aspects of ovarian function1 , useful in assessing conditions such as

polycystic ovary syndrome and premature ovarian failure.2

【SUMMARY】

Antimullerian hormone (AMH), also known as mullerian-inhibiting substance, is a dimeric

glycoprotein hormone belonging to the transforming growth factor-beta family. It is

produced by sertoli cells of the testis in males and by ovarian granulosa cells in females.

Expression during male fetal development prevents the mullerian ducts from developing

into the uterus, resulting in development of the male reproductive tract. In the absence of

AMH, the mullerian ducts and structures develop into the female reproductive tract. AMH

serum concentrations are elevated in males under 2 years old and then progressively

decrease until puberty, when there is a sharp decline. In females, serum AMH

concentrations are very low at birth, peaking after puberty, decrease progressively

thereafter with age, and become undetectable at menopause.

AMH is a product of granulosa cells of the preantral and small antral follicles in women. As

such, AMH can also serve as a molecular biomarker for relative size of the ovarian

reserve. In humans, this is helpful because the number of cells in the follicular reserve can

be used to predict timing of menopause. AMH can also be used as a marker for ovarian

dysfunction, such as in women with PCOS.

【PRINCIPLE】

AMH Test Cassette (Whole blood/Serum/Plasma) is based on fluorescence immunoassay to

detect the concentration of antimullerian hormone in human whole blood/serum/plasma. The

sample moves from sample pad to absorbent pad. If the specimen contains antimullerian

hormone, it attaches to the fluorescent microspheres-conjugated anti-AMH antibodies.Then

the complex will be captured by the capture antibodies coated on the nitrocellulose

membrane (Test line). The concentration of antimullerian hormone in the sample

correlates linearly with the fluorescence signal intensity captured on the T line. According

to the fluorescence intensity of the test and standard curve, the concentration of

antimullerian hormone in the sample can be calculated by Analyzer to show antimullerian

hormone concentration in specimen.

【REAGENTS】

The test include Anti-AMH antibody coated fluorophore and Anti-AMH antibody coated on

the membrane.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Do not use after the expiration date indicated on the package. Do not use the test if

the foil pouch is damaged. Do not reuse.

3. Avoid cross-contamination of specimens by using a new specimen collection

container for each specimen obtained.

4. Do not eat, drink or smoke in the area where the specimens and tests are handled.

Handle all specimens as if they contain infectious agents. Observe established

precautions against microbiological hazards throughout the procedure and follow

standard procedures for proper disposal of specimens. Wear protective clothing such

as laboratory coats, disposable gloves and eye protection when specimens are

assayed.

5. Do not interchange or mix reagents from different lots.

6. Humidity and temperature can adversely affect results.

7. Used testing materials should be discarded in accordance with local regulations.

8. Read the entire procedure carefully prior to any testing.

9. The AMH Test Cassette should only be used with the Novatrend Plus Analyzer by

approved medical professionals.

【STORAGE AND STABILITY】

1. The test should be stored at 4-30°C until the expiry date printed on the sealed pouch.

2. The test must remain in the sealed pouch until use.

3. Do not freeze.

4. Care should be taken to protect the components of the test from contamination.

Do not use if there is evidence of microbial contamination or precipitation.Biological

contamination of dispensing equipment, containers or reagents can lead to false results.

【SPECIMEN COLLECTION AND PREPARATION】

Preparation

1. Before performing the test, please make sure that all components are brought to room

temperature(15-30 °C). Cold buffer solution or moisture condensation on the membrane

can lead to invalid test results.

2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.

Sample Handling

1. Collect the specimen according to standard procedures.

2. Do not leave specimens at room temperature for prolonged periods. Serum and

plasma specimens may be stored at 2-8 °C for up to 5 days, for long term storage,

specimens should be kept below -20 °C. Whole blood collected by venipuncture should

be stored at 2-8 °C if the test is to be used within 1 day of collection. Do not freeze

whole blood specimens.

3. Bring specimens to room temperature prior to testing. Frozen specimens must be

completely thawed and mixed well prior to testing. Avoid repeated freezing and

thawing of specimens.

4. EDTA K2, Heparin sodium, Citrate sodium and Oxalate potassium can be used as the

anticoagulant tube for collecting the blood specimen.

Sample Dilution

1. The specimen (75μl of whole blood/serum/plasma) can be added directly with the

micro pipette into the buffer.

2. Close the tube and shake the sample by hand for approximately 10 seconds so

sample and dilution buffer mix well.

3. Let the diluted sample homogenize for approximately 1 minute.

4. It is best to place the diluted sample on an ice pack and leave the sample at room

temperature for no more than 4 hours.

【MATERIALS】

Materials Provided

• Test Cassettes • Specimen Collection Tubes With Buffer

• ID Card

• Package Insert

Materials Required But Not Provided

• Timer

• Centrifuge •Novatrend Plus Fluorescence Immunoassay Analyzer

• Pipette

• Specimen Collection Containers

【DIRECTIONS FOR USE】

Refer to Novatrend Plus Fluorescence Immunoassay Analyzer Operation Manual for the

complete instructions on use of the Test. The test should be in room temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature

(15-30 °C) prior to testing.

1. Turn on the Analyzer power. Then according to the requirements, select “Standard

test” or “Quick test” mode.

2. Take out the ID card and insert it into the Analyzer port.

3. Choose sample type, “Serum/Plasma” or “Whole Blood”.

4. Pipette 75 μl of Whole Blood/Serum/Plasma into the specimen collection tubes with

buffer, mix specimen and buffer well.

Note: The diluted specimen can then be used immediately or stored for up to 4

hours at 2-8 °C.

5. Pipette 75 μl of diluted specimen into the sample well of the cassette. Start the timer

at the same time.

6. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,

Standard Test mode and Quick Test mode. Please refer to the user manual of

Novatrend Plus Fluorescence Immunoassay Analyzer for details.

“Quick Test” mode: Insert the test cassette into the Analyzer at 15 minutes after

sample application, click “QUICK TEST”, fill the test information and click "NEW

TEST" immediately. The Analyzer will automatically give the test result after a few

seconds.

“Standard Test” mode: Insert the test cassette into the Analyzer immediately after

sample application, click “STANDARD TEST”, fill the test information and click "NEW

TEST" at the same time, the Analyzer will automatically counting down 15 minutes.

After the countdown, the Analyzer will give the result at once.

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products details

Quantitative AMH Test Cassette for Fluorescence Immunoassay of Ovarian Reserve Function

Quantitative AMH Test Cassette for Fluorescence Immunoassay of Ovarian Reserve Function

Custom Monoclonal Antibodies

mono clonal antibody