Beijing Kinghawk CO.,LTD

HIV1+2 Antibody Rapid Test kit （for Urine）（Colloidal Gold）

INTENDED USE

The HIV1+2 Antibody Rapid Test kit is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to HIV 1+2 in human urine.

INTRODUCTION

The one step rapid anti-HIV(1+2) test is a colloidal gold, rapid immunochromatographic assay for the qualitative detection of antibodies to human immunodefficiency virus (HIV) in human urine. This test is a screening test, and all positives must be confirmed using an alternate test such as western blot.

PRINCIPLE

The membrane is coated with recombinant HIV antigens on the test line region of the device. When urine specimen is applied at one end of the membrane, it reacts with recombinant antigens labeled with colloidal gold particle that has already been applied to the specimen pad at the same end .The mixture then migrates chromatographically towards the other end of membrane and reacts with the recombinant HIV antigens on the membrane in the test line region, showing a positive result. The absence of the colored line indicates that the urine 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.

PACKAGE SIZE

50 Test strips

1user’s guide

50 Plastic droppers

50 cups

PRECAUTIONS

1.ALL positive results must be confirmed by an alternative method.

2.Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.

3.Devices used for testing should be autoclaved before disposal.

4. Do not use kit materials beyond their expiration dates.

STORAGE

Store as packaged in the sealed pouch at 4-25℃. Shelf life 12 months.

The test device must remain in the sealed pouch until use.

SPECIMEN COLLECTION

1, Urine will be used in this test.

2, Urine should be collected in the dry, clean cups and can be collect at anytime of a day. If during the menstrual period, please take the midstream specimen of urine. The specimen should be clear enough without any contaminant, eg, menstrual blood, haematuria, bacteria. If there is precipitation, please filter or centrifuge to get the clear supernate for the test.

3, It’s better to test immediate after the collection, especially for the individual use. For clinical lab, if the test cannot be performed timely, please store the specimens at 2～8℃ and test them within one week. The specimen cannot be freeze without protectant.  

DIRECTIONS OF USE

Please read the insert carefully before use. Otherwise, the result might be unreliable.

Equilibrate the kit  and specimen (if cold) to room temperature (15-30℃) prior to testing.

Remove the strip from the foil pouch

Place the device on a clean and level surface. Dispense 2 drops (~70 µl) of urine specimen to the circular sample well of the test card using the plastic dropper.

Interpret test results at 10~15 minutes. 

NOTE

1. The positive results could appear as soon as 1 minute for a sample with high levels of HIV antibodies.

2. Do not interpret result after 20 minutes.

INTERPRETATION OF RESULT

POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).

NEGATIVE: one red line appears in the control region (C), No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeated the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

NOTE: Low titers of anti-HIV 1/2 antibodies might result in a faint line appearing in the region (T) after a prolonged time The intensity of the red color in the test line region (T) will vary depending on the concentration of anti-HIV 1/2 antibodies present in the specimen. However, neither the quantitative value nor the rate of increase in anti-HIV 1/2 antibodies can be determined by this qualitative test.

LIMITATIONS

1. Only urine specimens that are clear and with good fluidity can be used in this test. 

2. For diagnostic use only. This test is a screening test, and all positives must be confirmed using an alternate test.

3. Unclean devices and incorrect operation might cause the wrong result.

4. It's not suitable to be used by the patients who are carrying out antiviral therapy. It might generate false negative results.