DIAGNOSTIC KIT FOR HIV (1+2) ANTIBODY (COLLOIDAL GOLD)

Intended Use

The rapid test for HIV (1+2) antibody from KHB is an in vitro, visually read test for the qualitative determination of antibodies against HIV‐1 and HIV‐2 in human serum, plasma or whole blood. This product is intended for use as an aid to detect antibodies against HIV (1+2) from individuals.

The Inno Scientific  HIV RTK pack comes with diluent, sterile lancet, pipette, alcohol pad, instruction leaflet and KHB HIV Diagnostic Kit (HIV1+2)

Principle of the Procedure

The rapid test of HIV (1+2) antibody from KHB adopts the solid phase colloidal gold immunochromatographic technology for the qualitative detection of antibodies against HIV‐1/HIV‐2. The gold HIV‐1 gp160(2)  conjugate and the gold HIV‐2 gp36(3)  conjugate are coated to the conjugate pad in advance. The test line (gp36 and gp41 antigens) and the control line (monoclonal antibody against gp160) are pre‐coated on the  surface  of  Nitrocellulose  (NC)  membrane.  When  the  sample  is  added  to  the  sample  pad,  it  migrates  through  the  conjugate  pad, reconstitutes and mixes with the colloidal gold‐antigen complex and moves on till the end of the strip. A reddish‐purple test line will be visible in the strip if there are enough antibodies against HIV‐1/HIV‐2 in the sample. If the specific antibodies are absent, or present at a very low level, no color change will occur in the test line(4, 5).

Materials Provided

• HIV (1+2) antibody test cassette                

• Sample diluent 

• Instructions for use 

• Pipette

• Sterile lancet

• Alcohol pad

Safety Precautions 

• Wear gloves during the entire testing process.

• Do not pipette by mouth.

• Do not eat or smoke while handling samples.

• Clean and disinfect all the areas that may be

   contaminated by spills of samples or reagents with 

   appropriate disinfectant.

• Decontaminate and dispose of all samples, reagents, and other potentially contaminated material

   as if they were infectious wastes, in a bio-hazard container.

Handling Precautions

• Do not mix and interchange different samples.

• Do not use sample diluent from different batches in one

   single test.

• Use of hemolytic samples, rheumatoid factors‐contained

   samples and lipidemic, icteric samples may lead to

   impairing the test result.

• Pooled samples or samples other than specified (i.e.

   saliva, urine) are strictly forbidden to be tested.

• Ensure the sample is added correctly prior the addition of

   sample diluent.

Warning

• For in vitro diagnosis of the infection of HIV only, other diseases cannot be diagnosed with any

  composition of this kit.

• The cassette, individually enclosed in a foil pouch and packed every 50 in a kit, is only for "single

   use".

• Do not use the test cassette if the pouch is damaged or the seal is broken. Contact the supplier

  when it happens.

• The sample diluent in this kit contains Sodium Azide as the preservative, be cautious while in

  operation with the kit.

• Care should be taken to avoid the contact between the sample area of the cassette and the diluent

   bottle to avoid the contamination of the diluent.

Storage Requirements

• The test cassettes and the sample diluent must be stored

   at 4~30℃ until expiration date.

• Do not use expired devices.

• Kit components are stable until expiration date when handled and stored as this instructions for

   use required.

• Test cassette should be used immediately upon unpacking the pouch.

Sample Collection and Storage

Requirements

• Human serum, plasma, and whole blood samples should be collected through venipuncture (or

  whole blood through fingerstick).

• Whole blood and plasma sample can be prepared with EDTA, heparin or sodium citrate as

   anticoagulant. The use of other anticoagulants may affect the results of the test.

Test Procedure

Equilibrate all samples and the device to room temperature

before testing.

Sample diluent from different batches cannot be mixed. 

1.  Take out a test cassette from the foil pouch, and place it on a horizontal surface.

2.  Use the sample of either serum/plasma or whole blood: Add 40μl of sample   to the sample area

     firstly (Figure 1), then slowly add 1 drop of sample diluent   to the same area (Figure 2). Please

     avoid direct contact of the diluent bottle   with the sample area.

3.  Wait a minimum of 15 minutes (up to 30 minutes) and read result.

Positive Result (Figure 3)

Clear visible reddish‐purple bands appear both at the control line (C‐line) and the test line (T‐line) of the cassette.

The test result is valid even the band of the control line (C‐line) appears much lighter or darker than the band of test

line (T‐line).

Negative Result (Figure 4)

A reddish‐purple band appears only at the control line (C‐line) of the cassette (Figure 4).

Invalid Result 1 (Figure 5)

Reddish‐purple band appears at neither the control line nor the test line of the cassette (Figure 5). Repeat the test of

the sample. If the result remains the same, then the result is invalid and contact KHB supplier.