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Quantitative LH Test Cassette Whole Blood/Serum/Plasma for Predicting Ovulation System luteinizing hormone

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

Detail Information

Product Description

Detail Information

Test Range:

1-300 MIU/mL

Test Type:

Flourescence Immunoassay

Sample Type:

Serum/Plasma/Whole Blood

Storage Temperature:

4-30℃

Time To Results:

15 Minutes

Sample:

Available

Application:

In Vitro Diagnostics

Format:

Cassette

Qualified:

Pack:

10T/25T

Highlight:

mouse monoclonal antibodies

mab antibodies

Product Description

The LH Test Cassette (Whole Blood/Serum/Plasma) is intended for in vitro quantitative

determination of luteinizing hormone (LH) in human whole blood/serum/plasma as an aid

in the detection of ovulation.

【SUMMARY】

Ovulation is the release of an egg from the ovary. The egg then passes into the fallopian

tube where it is ready to be fertilized. In order for pregnancy to occur, the egg must be

fertilized by sperm within 24 hours after its release. Immediately prior to ovulation, the

body produces a large amount of luteinizing hormone (LH) which triggers the release of

a ripened egg from the ovary. This “LH surge” usually takes place in the middle of the

menstrual cycle.1

The LH Test Cassette (Whole Blood/Serum/Plasma) is a complete system to help predict

the time of ovulation, and peak fertility. It is during this fertile time that pregnancy is most

likely to occur.

The LH Test Cassette (Whole Blood/Serum/Plasma) detects the LH surge in whole

blood/serum/plasma, signaling that ovulation is likely to occur in the next 24-36 hours.

The test utilizes a combination of antibodies including a monoclonal LH antibody to

selectively detect elevated levels of LH.

Important: The LH surge and ovulation may not occur in all menstrual cycles.

The LH Test cassette is a test that quantitatively detects the LH level in whole

blood/serum/plasma specimen. The test utilizes a combination of antibodies including a

monoclonal anti-LH antibody to selectively detect elevated levels of LH. The minimum

detection level is 1 mIU/mL.

【PRINCIPLE】

The LH Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence

Immunoassay for the detection of LH in human whole blood/serum/plasma to evaluate

the onset of menopause in women. The specimen moves through the strip from

specimen pad to absorbent pad. If the specimen contains LH, it attaches to the

fluorescent microspheres-conjugated anti-LH antibodies. Then the complex will be

captured by the capture antibodies coated on the nitrocellulose membrane (Test line).

The concentration of LH in the specimen 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 LH in the specimen can be calculated by Analyzer to show LH concentration in specimen.

【REAGENTS】

The test contains anti-LH antibody conjugated fluorophores and capture reagents 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.

5. 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.

6. Wear protective clothing such as laboratory coats, disposable gloves and eye

protection when specimens are assayed.

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

8. Humidity and temperature can adversely affect results.

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

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

11. The LH Test Cassette should only be used with the

Analyzer by approved medical professionals.

【STORAGE AND STABILITY】

1. The kit 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 kit 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.

Specimen 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 1 day, 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. Whole blood collected by finger stick should be tested immediately.

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

coagulant tube for collecting the blood specimen.

Specimen Dilution

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

micro pipette into the buffer.

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

specimen and dilution buffer mix well.

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

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

temperature for no more than 8 hours.

【MATERIALS】

Materials Provided

• Test Cassettes

• Specimen Collection Tubes with Extraction Buffer

• ID Card

• Package Insert

Materials Required But Not Provided

• Timer

• Centrifuge

• Pipette • Fluorescence Immunoassay Analyzer

【DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer Operation Manual for the

complete instructions for use of the test. The test should be conducted 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 requirement, select “Standard Test”

or “Quick Test” mode.

2. Take out the ID Card and insert it into the Analyzer ID Card Slot.

3. Transfer 75 μL of whole blood/serum/plasma into the buffer tube by pipette; mix the

specimen and the buffer well.

4. Add diluted specimen with a Pipette: Transfer 75 μL of diluted specimen into the

specimen well of the test cassette. Start the timer at the same time.

5. There are two test modes for FIATEST GO Fluorescence Immunoassay Analyzer,

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

Fluorescence Immunoassay Analyzer for details.

“Quick Test” mode: After 15 minutes of adding specimen, insert the test cassette into

the Analyzer, 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

adding specimen, click “STANDARD TEST”, fill the test information and click "NEW

TEST" at the same time, the Analyzer will automatically countdown 15 minutes. After the

countdown, the Analyzer will give the result at once.

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products details

Quantitative LH Test Cassette Whole Blood/Serum/Plasma for Predicting Ovulation System luteinizing hormone

Quantitative LH Test Cassette Whole Blood/Serum/Plasma for Predicting Ovulation System luteinizing hormone

mouse monoclonal antibodies

mab antibodies