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One step HIV 1/2 Test Blood

INTRODUCTION:

The MAXY test Anti-HIV1/2  (M-T HIV1/2)is a rapid direct binding test for the visual detection of anti-HIV1/2 antibodies (anti-HIV1/2 ) in serum or whole blood as an aid in the diagnosis of HIV1/2 infection. test result are read visually without any instrument.

M-T HIV1/2 test is based on the principle of inter-second antibody enzyme immunoassay for the semi-quantitative determination of ANTI-HIV1/2 in serum or whole blood. Synthetic and recombinant HIV1/2 antigens were employed to specifically identify anti-HIV antibodies with extremely high sensitivity. 2 ncu/Ml whole test only takes 3 minutes. results\

The formation of a large dot(*)or a line of three smaller dots(***)provides an easy readout for positive and negative test. The three smaller dots(***)also serve as an internal control The center dot is a  NEGATIVE control and the two outside dots are the HIV1 positive control,THE THREE DOTS ARE HIV2 POSITIVE CONTROL,they only appear when all reagents are working and the sequence of adding reagents are performed correctly.

MATERIALS PROVIDED:

1. Test devices(each device for one single test)

2. Gold conjugate diluetion

MATERIALS REQUIRED BUT NOT PROVIDED:

1. Specimen collection containers

2. Pipette

3. Pipette tips

STORAGE:

The kit should be stored at 2-8℃. After opening the package, it may be stored at room temperature not high than 30℃ for one week. gold conjugate solution must be stored at 2-8℃..

SPECIMEN COLLECTION:

No special patient preparation is necessary. collect blood into container without anticoagulant. allow the blood to clot and separate the serum from the clot. use the serum for testing.

FOR WHOLE BLOOD,JUST TAKE 30-40ul OF WHOLE BLOOD INTO REACTION WELL ON THE TEST DEVICE AND MIX WITH GOLD CONJUGATE SOLUTION.

PROCEDURE INSTRUCTIONS:

Bring all reagents, test devices, specimens, references and other materials to room temperature prior before testing. Do not mix the caps from different reagent vials.

1. Add 10 drops of gold conjugate solution into reaction well on the test device.

2. Using a pipette, add 30ul serum or whole blood sample to the reacti9n well and mix with gold conjugate solution by pipette the mixture up and down.

3. Use a dropper or pipette, transfer all the solution from the reaction well and add to the pre-filter filter well. Allow the specimen to soak completely through the pre-filter.

4. Add 10 drops of gold conjugate solution to the pre-filter. allow the solution to soak through.

5. Remove and discard pre-filter, read results.

　

INTERPRETATION OF RESULTS:

NEGATIVE:

Only ONE ROUND SPOT(*) in centre ARE NEGATIVE DOT.

　

POSITIVE:

HIV1 there is one sport in centre and another sport under the left.

HIV2 there is one sport in centre and another sport under the right.

HIV1/2 there is one sport in centre and there are two sports under the centre sport.

　

Invalid

There are no round dots are invalid . 

　

　

     HIV1                 HIV2                      HIV1/2                 NEGATIVE            INVALID

    

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Interpretation of result

　

Negative: Only one pink colored band appears on the control region no apparent band on the test region.

Positive: In addition to a pink colored band,a distinct pink colored band will also appear in the test region.

Invalid:  A total absence of color in both regions is an indication of procedure error and/or that test reagent deterioration has occured