Dewei Hepatitis E Virus Igm Antibodies Check Hev Rapid Test

• Customization: Available
• Type: IVD Instrument
• Parameter: Hev Igm
• Model NO.: HEV-DW02
• Specimen: Whole Blood/Serum/Plasma
• Test Time: 15 Mins
• Test Type: Qualitative Detection
• Warranty: 24 Months
• Transport Package: Cartons
• Specification: 10 KG, 0.07CBM/Carton
• Trademark: Dewei
• Origin: China
• Production Capacity: 250, 000 Tests/Week

Product Description

Product Description

INTENDED USE
The HEV IgM Test Kit is a lateral flow chromatograchic immunoassay for the qualitative detection of IgM antibodies to Hepatitis E virus (HEV) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HEV. Any reactive specimen with the HEV IgM Test Kit must be confirmed with alternative testing method(s) and clinical findings.

PRINCIPLE
The HEV IgM Test Kit is a lateral flow chromatographic immunoassay. The test cassette consist of: 1) a burgundy colored conjugate pad containing HEV antigens conjugated with colloidal gold (HEV conjugates) and rabbit IgG-gold conjudates, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with monoclonal anti-human IgM antibody, and the C line is pre-coated with goat anti-rabbit IgG antibody.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. Anti-HEV IgM, if present in the specimen, will bind to the HEV conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM forming a burgundy colored T line, indicating a HEV IgM positive test result.
 

Product Name	Hepatitis E Virus (HEV) Rapid Test
Usage	For professional ivd use only
Test	Qualitative Test
Method	Colloidal Gold Immunochromatography
Manufacturer	Dewei Medical Equipment Co., Ltd
Main Content	Rapid Test Cassette+Buffer+Disposable Pipettes+IFU
Certificates	CE, ISO13485
Storage	4-30ºC

OPERATION MANUAL
Bring tests, specimens, and/or controls to room temperature(15-30ºC) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 10 μl whole blood/serum/plasma sample to the specimen well(S) of the cassette with the provided disposable pipette, and add 2 drop (appx. 60-80μl) of buffer, then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
4. Results interpretation.
Positive: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
Negative: The presence of only control line (C) within the result window indicates a negative result.
Invalid: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.

PERFORMANCE CHARACTERISTIC
Relative Sensitivity: 98.9%
Relative Specificity: 99.2%
Overall agreement: 99.05%

DETAILED PICTURE

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ABOUT US

Dewei Medical Equipment Co., Ltd is a high-tech enterprise specialized in developing and marketing of Medical Consumables like Rapid Test Kits, Hematology Analuzer and Reagents, Washing solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.

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