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.

 

The HIV-Card/Strip is a rapid test to qualitatively detect the presence of antibody to HIV-1 and/or -2 in serum or plasma specimen. The test utilizes a combination of protein A coated particles and multiple recombinant HIV proteins(including gp36, gp41, p24, gp120) to selectively detect antibody to the HIV-1 and HIV-2 in serum or plasma.

 

The HIV-Card/Strip is a qualitative, membrane based immunoassay for the detection of antibody to HIV in serum or plasma. The membrane is coated with recombinant HIV antigens on the test line region of the device. When a serum or plasma specimen is applied at one end of the membrane, it reacts with Protein A coated particle that has already been applied to the specimen pad at the same end. The mixture then migrates chromatographically towards the other end of the membrane and reacts with the recombinant HIV antigens on the membrane in the test line region. If the serum or plasma contains antibodies to HIV-1 or HIV-2, a colored line will appear in the test line region, showing a positive result. The absence of the colored line indicates that the serum or plasma does not contain the anti-HIV antibodies, showing a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

 

 

The HIV-Card/Strip can be performed using either serum or plasma.

 

Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at

 

room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.

 

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.If specimens are to be shipped, they should be packed in compliance with federal regulations for transportation of etiologic agents.

 

 

Unopened test kits should be stored at 4-30C

 

 

1. 1.When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.


2. 2.Use the disposal pipette inside the pouch, add about 150ul sample into the Sample Well of the card/srip.


3. 3.Wait 5-30 minutes and read results. Do not read results after 30minutes.