Specifications

Description

HAV IgM rapid test kit
CE Certificate
ISO 13485 Certificate

HAV IgM rapid test kit

 

INTENDED USE

The HAV IgM One Step Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A virus (HAV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive specimen with the HAV IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

TEST PRINCIPLE

The HAV IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-human IgM antibody conjugated with colloid gold (IgM conjugates) and, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with recombinant HAV antigen, and the C band is pre-coated with goat anti-mouse IgM antibodies.

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-HAV IgM if present in the specimen will bind to the IgM conjugates. The immunocomplex is then captured on the membrane by the pre-coated HAV antigen, forming a burgundy colored T band, indicating a HAV IgM positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-mouse IgG/ IgM-gold conjugate regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device..

Materials provided

1. Each kit contains 25 test devices, each sealed in a foil pouch with three items inside:

a. One cassette device.

b. One pipette dropper.

c. One desiccant.

 

2. One bottle of buffer

3. One package insert (instruction for use).


Terms

FOB Price:
Minimum Order: 10000 Piece/Pieces
Port: Shanghai
Payment Terms: L/C,T/T

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