Payment & Shipping Terms:
Diagnostic Kit for Hepatitis E Virus Antibody (Colloidal Gold)
The HEV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis E type virus (HEV) in human serum/ plasma.
HEV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HEV in human serum/plasma. Mouse anti human-IgM µ strands are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HEV recombinant antigens. If antibodies to HEV are present, a pink colored band will develop on the membrane in proportion to the amount of HEV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HEV.
REAGENTS AND MATERIALS PROVIDED
1. One sealed pouched cassette with desiccant & disposable pipettet.
WARNING AND PRECAUTIONS
STORAGE AND STABILITY
Store HEV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.
SAMPLE COLLECTION AND PREPARATION
1. Carefully apply 3µl sample into a centrifuge tube with 1.5ml dilution, oscillate and mix them to diluted sample.
2. Remove the test cassette from pouch by tearing.
3. Add 50-80 ul or 2-3 drops of mixture into sample well.
4. Observe the result in 20 minutes.
INTERPRETATION OF RESULTS
668 HEV diagnostic samples were tested with the HEV Rapid Screen Test. The results are summarized in the table below.
|Diagnostic Sample type||Number of sample tested||HAV Rapid Screen Test|
Sensitivity=98.5%; Specificity=99.2%; Total accuracy=99.1%
In the study, 38 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.
The study involved the same specimens containing one positive and one negative. The samples were analyzed in 38 independent assays with HEV Rapid Screen Test. Originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
LIMITATION OF THE PROCEDURE
Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Contact Person: Ms. Anna Lee