Медицинский лабораторный набор HIV1/2, быстрый тест на ВИЧ, травяное лечение ВИЧ

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Product Overview

Description


 

Certificate
GMP
SFDA
ISO13485
ISO9001:2008

 

INTENDED USE

 

HIV- Card/Strip rapid test is a rapid chromatographic immunoassay for the qualitative detection of antibody to Human Immunodeficiency Virus (HIV) type-1 and/or type-2 in serum or plasma.

 

SUMMARY AND PRINCIPLE OF THE TEST

 

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS).  The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope.  Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with a high potential risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and -2 elicit an immune response. Detection of HIV antibodies in serum or plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV.  Despite the differences in their biological characteristics, serological activities and genome sequences of HIV-1 and -2 show strong antigenic cross-reactivity.  Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.

 

PERFORMANCE OF THE TEST:

Compare with ELISA kits, the rapid test Card/Strip 100 % relative sensitivity and 99.8%relative specificity.

 

LIMITATIONS OF THE ASSAY

 

This HIV-Card/Strip is for in vitro use only. The test should be used for the detection of antibodies to HIV in serum or plasma specimen.

 

This HIV-Card/Strip will only indicate the presence of antibodies to HIV in the specimen and should not be used as the sole criteria for the diagnosis of HIV-1 and/or -2 infection.

 

For confirmation, further analysis of the specimens should be performed, such as ELISA and/or western blot analysis.        As with all diagnostic tests, all results must be interpreted         together with other clinical information available to the physician.

 

If the test result is negative and clinical symptoms persist, additional follow-up tests using other clinical methods are recommended. A negative result at any time does not preclude the possibility of HIV -1 and/or -2 infection.

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