**"This product is not distributed in the European Union. It does not bear the CE marking as it has not undergone the conformity assessment procedures of the European Directive 98/79/EC, for in vitro medical devices".

One Step Cassette Style ANTI-HIV 1+2 Serum/Whole Blood Test

INTRODUCTION

One Step Cassette Style Anti-HIV 1+2 Test is a rapid direct binding screening test for the presence of antibodies to HIV 1 and HIV 2 viruses. The test is based on the principle of double antigen sandwich immunoassay for detection of Anti-HIV in serum or whole blood. Purified recombinant antigens are employed to identify Anti-HIV specifically. This one step test is very sensitive and only takes about 10-15 minutes. Test results are read visually without any instrumentation.

Catalogue name	Type	Packing	Description
UNILATEX 667	Cassette	Boxes of 25	HIV 1+2 Serum/Whole Blood Test, for the Professional Use only.
UNILATEX 668	Cassette	Boxes of 1	HIV 1+2 Serum Test, for Self-Testing

1) Sector for Professional Use: Hospitals, Ngo´s, Governments, in bulk basis

SPECIMEN COLLECTION

The One Step HIV 1+2 Test can be run on serum or whole blood samples. The test works best on fresh samples. 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 (at 2 to 4°C) for up to 3 days. If testing cannot be done within 3 days, serum should be stored in a freezer (at -20°C or colder). Whole blood specimens cannot be frozen. Make sure to bring the serum specimen to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

MATERIALS PROVIDED

1. Test kit

2. Specimen diluent in dropper bottle -Reagent

3. Plastic Pipette to dispense sample

TEST PROCEDURE

1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test device from the pouch.

2. Using the plastic pipette provided, draw the sample into the pipette until the level is at the bottom of the first bulb (do not draw sample past the Fill Line). Dispense this amount of sample onto the sample well of the cassette.

3. Add about 2 drops (0.2ml) of diluent provided onto the sample well. Use the dropper bottle provided, not the sample pipette.

4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes.

2) Sector: Self-testing

MATERIALS PROVIDED

1. Test kit

2. Specimen diluent in a capsule -Reagent-

3. Lancet to stick on the finger

Take 3 drops of blood with a pipette and add them to the test device

Positive

Negative

INTERPRETATION OF RESULTS

Ø Negative: Only one colored band appears on the control (C) region.

No apparent band on the test (T) region.

Ø Positive: In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region. Please consult your physician to perform a much more detailed exam.

Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has been deteriorated.

STORAGE AND STABILITY

The test kit should be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, moisture and heat.

PRECAUTIONS

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. For samples that test positive by the One Step ANTI-HIV Test, a more specific confirmatory test 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 a rapid test is not sufficient to diagnose AIDS even if antibodies are present. Also, a negative result does not preclude the possibility of infection with HIV.

5. The instructions for use and reading of the test must be followed exactly in order for the test to perform properly.

Effectiveness: 99 %

3) Empirical Evidence

AIDS Control and Inspection Centre

Unilatex Laboratory, Beijing 21.1.2008

Report Of Quality Evaluation to Clinical Applications of HIV 1/2 Antibody Rapid Test Device

Test Kit Name: HIV 1/2 Antibody Colloidal gold Rapid Test Device
Purpose of the evaluations: To evaluate the Sensitivity and Specificity of above HIV Device.

1.Materials and Methods:
1). Device Name: HIV 1+2 Rapid Test
2). Sera to be Tested: Positive confirmed HIV Antibody Positive sera from 149 patients and negative HIV Antibody Negative Sera from 174 individuals.
3) Evaluation Method: the device was used to test the 322 Sera Specimens mentioned above, the evaluation was carried by two operators in blind according to the manufacturer package inserts
2.Results of 322 Sera Specimens:

HIV Antibody
Results	Positive	Negative	Total:
Device Positive	148	0	148
Device Negative	1	174	175
Total:	149	174	322

3. Conclusions:
Sensitivity: 148/149= 99%
Specificity: 174/174=100.00%

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