HAV IgM rapid test kit

HAV IgM rapid test kit
Minimum Order Quantity: 10,000 Piece/Pieces
Supply Ability: 1,000,000 Piece/Pieces per Week
Payment Terms: L/C,T/T
Packaging & Delivery

Packaging Details: 25 Tests/Box or as request
Delivery Detail: 3 ~ 4 weeks

Specifications
HAV IgM rapid test kit
CE Certificate
ISO 13485 Certificate

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).

H.Pylori Antibody One Step Rapid Test
Minimum Order Quantity: 10,000 Piece/Pieces
Supply Ability: 500,000 Piece/Pieces per Month
Payment Terms: L/C,T/T
Packaging & Delivery

Packaging Details: 25 tests/box or as requirement
Delivery Detail: 3 ~ 4 weeks
Specifications
H.Pylori Antibody Rapid Test
CE Certificate
ISO 13485 Certificate
H.Pylori Antibody One Step Rapid Test
Intended Use
The H.Pylori Antibody One Step Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) anti- Helicobacter pylori (H. Pylori) in human serum or plasma.
Introduction
Helicobacter pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis.1,2 The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H. Pylori infection with stomach cancer.3
H. Pylori colonizing in the gastrointestinal system elicits specific antibody responses4,5,6 which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. Pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. Pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence.7
MATERIALS SUPPLIED
Each test contains :
1. One cassette device
2. One pipette dropper
3. One desiccant
Each kit contains:
1. 25 test devices
2. One bottle of buffer
3. One instruction