HIV 1&2 Rapid Screen Test is a rapid direct binding test for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 and Type2 (HIV) in human serum/plasma/whole blood as an aid in the clinical assessment of HIV infection.
The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the immune system, destroying or impairing their function. As the infection progresses, the immune system becomes weaker, and the person becomes more susceptible to infections. The most advanced stage of HIV infection is acquired immunodeficiency syndrome (AIDS). It can take 10-15 years for an HIV-infected person to develop AIDS. The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with Western Blot. The HIV 1&2 Rapid Screen Test is a simple, visual qualitative test that detects antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

QUICK DETAILS

Product Name:  HIV 1&2 Rapid Screen Test  
Type:  Pathological Analysis Equipment  
Instrument Classification:  Class II  
Certification:CE/ ISO
Storage:2’C-30’C  
Packing:  Pouch/Box
Format / SizeCassette: 3.0mm 4.0mm
Accuracy:  99.6%
Function:  Detect HIV  1&2 Antibodies

ANTIGEN INFORMATION

Gene Symbols:HIV-1/HIV-2

ASSAY FORMAT

Number of Targets Detected:1
MethodologyChromatographic Immunoassay
Specimen:Serum/Plasma/Whole Blood
Design Principle:Sandwich-based
Method of Detection:Colloidal Gold
Assay TypeQualitative Detection
Solid Support:Lateral Flow

PRINCIPLE

The HIV 1&2 Rapid Screen Test is a qualitative membrane strip-based immunoassay for the detection of HIV antibodies in Whole Blood / Serum / Plasma. In this test procedure, the membrane is pre-coated with recombinant HIV antigens in the test line regions, T1 and T2. The T1 line is pre-coated with HIV-1antigen and the T2 line is pre-coated with HIV-2 antigen. After a Whole Blood /Serum / Plasma specimen is placed in the specimen well, it reacts with HIV antigen coated particles that have been applied to the specimen pad. As the mixture is allowed to migrate along the test strip, the conjugate-HIV antibody complex is captured by a second HIV antigen immobilized on the membrane forming a coloured test band in the test region. A negative sample does not produce a test band due to the absence of conjugate/HIV antibody complex. The antigens used in the conjugate test are recombinant proteins that correspond to highly immunoreactive regions of HIV1 and HIV2. A coloured control band in the control region appears at the end of test procedure regardless of test result. The control band indicates that the colloidal gold conjugate is functional.   

TEST PROCEDURE:

1) Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible. Place the test strip on a clean and level surface. 
2) For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen pad of the test strip, then start the timer. See illustration below.
3) For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 35μl) to the specimen pad of the test strip, then add 2 drops of buffer (approximately 70μl) and start the timer.  
4) Wait for the coloured line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.  

Important: In order to prevent an incorrect reading, do not read the test results after more than 8 minutes. If the test is read after 8 minutes, the intensity of the coloured lines may change or a new line may appear. To avoid confusion, discard the test device after interpreting the result

PRODUCT SPECIFICATIONS

HIV 1&2 Rapid Screen Tests are supplied for both the professional laboratory environment and also Point of Care (POC) situations in remote settings. Components of each for of kit set are:

COMPONENTS PROVIDED

POC – HIV (1&2) test kits are individually packed testing kits that incorporate the required components to perform a test in remote settings by medical professionals, first responders and trained personal. The POC – HIV 1&2 test kits include the following components:

  • Test Cassette
  • Buffer Solution
  • Lancet
  • Transfer Pipette
  • Prep Pad

Laboratory Environments require the testing device and supporting reagents and therefore the test kit comprises of:

  • 40 Individually packed test cassettes
  • Buffer Solution
EnvironmentsTotal Number of TestsMOQ
Laboratory40 Tests Per Box (Test Cassettes and Buffer Solution only)5 Boxes
Point of Care20 Complete Test Kits per box (Including Lancets, Alcohol Swabs and Pipettes)5 Boxes