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HAV IgM rapid test kit(China)

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  Product Name: HAV IgM rapid test kit
  Product Categories: Medical devices/Diagnostic Devices
  Post Date: Aug 16,2016
  Expiry Date: Aug 16,2017
  Description: Payment Method: T/T,L/C
NEUTRAL PACKING: healgencaroline
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).

  Company: Zhejiang Orient Gene Biotech Co., Ltd     [ China ]
  Address: 23E,No.1 2005 Alley,Huangxing Road,Yangpu District
  Contact: Caroline Tan
  Tel: +86-136-71972583
  Mobile: +86-136-7197258
  Fax: +86-021-55059677
  Email: caroline@healgen.com
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