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　                                                                     One step HIV Test Serum

   INTRODUCTION

 

  One Step Cassette Style Anti-HIV Test  is a rapid direct  binding test for the visual detection of HIV antibodies  (ANTI-HIV) in serum as an aid in

 the  diagnosis of HIV infection. The test is based on  the immunoassay  for  determination of  ANTI-HIV in serum. Purified recombinant antigens

 are employed to specifically identify ANTI-HIV with high sensitivity. This one step test only takes  about 10-20 minutes. Test results are read

visually without any instrument.

 

  SECIMEN CONLLECTION

  For serum , collect blood into a container without anticoagulant .Allow the blood to clot and separate the serum from the clot. Use the serum for

testing .If the specimen cannot be tested on the day of  collection, store the serum specimen in a refrigerator or freezer . .Bring   the specimens

 to normal room temperature before testing Do not freeze and thaw the repeatedly .

 

  TEST PROCEDURE

　

  1. When you are ready to begin testing , open the sealed pouch by tearing along the notch . Remove the test from the pouch.
  2.Add 3uL sample into the sample well on the cassette .Then add 6 free falling drops of diluent’s (250UL) to the sample well.
  3. Wait 10-15 minutes and read results .Do not read results after 30 minutes.
 

  INTERPREATION OF RESULTS
 

  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

 

  PRECAUTION

 

  1.For in vitro diagnostic use only.

  2.Do not use test kit beyond expiry date.

  3.The test device should not be reused.

  4.The One Step ANTI-HIV Test is designed to detect antibodies against HIV in serum. Testing of any other body fluids has not been validated

and may yield appropriate  results                                                                                                                                                                                                                                                                                                                                                  

   5.For samples that test positive (reactive) by the One Step ANTI-HIV Test, more specific confirmatory testing should be done .A clinical

evaluation of the patient’s situation and history should also be made before a final diagnosis is established .The use of rapid test is not

sufficient to diagnosis AIDS even if antibodies are present .Also a negative result does not preclude the possibility of infection with HIV.

 6.The instructions for use and reading of the test instructions must be followed carefully for the test to perform properly.

　

    

  

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