Colloidal Gold Covid Test Efficient Medical Diagnostic Test Kits Fast Human Immunodeficiency Virus Test

Efficient Convenient And Fast Detection Of Human Immunodeficiency Virus 1/2

      The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV 1 and/or HIV 2 in whole blood, serum or plasma.

Detection Principle

      The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1/2 in whole blood, serum or plasma. The membrane is pre‐coated with recombinant HIV antigens. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region. If the specimen contains antibodies to HIV 1 and/or HIV 2, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies, a colored line will not appear in the test line region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND PREPARATION

• The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum, or plasma. 
• To collect Fingerstick Whole Blood specimens: 
• Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.  
• Add the Fingersitck Whole Blood specimen to the test device by using a capillary tube or hanging drop.
• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non‐hemolyzed specimens.
• Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2‐8°C for up to 3 days. For long term storage, specimens should be kept below ‐20°C. Whole blood collected by venipuncture should be stored at 2‐8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15‐30°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 2 drops of specimen (approximately 80 μL) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 μL) and start the timer.
3. Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret results after 20 minutes

INTERPRETATION OF RESULTS

NOTE:

The intensity of the color in the test line region (T) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of colored in the test region (T) should be considered positive. 

LIMITATIONS OF THE TEST

1. The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of antibodies to HIV in whole blood, serum or plasma. Neither the quantitative value or the rate of increase in HIV antibody concentration can be determined by this qualitative test.
2. This test will only indicate the presence of antibodies to HIV in the specimen and should not be used as the sole criteria for the diagnosis of HIV 1 and/or HIV 2 infection. 
3. For confirmation, further analysis of the specimens should be performed, such as ELISA and/or Western Blot analysis.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. If the test result is negative and clinical symptoms persist, additional follow up tests using other clinical methods are recommended. A negative result at any time does not preclude the possibility of HIV 1 and/or HIV 2 infection.

Preservation and stability of products

The kit can be stored at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested.
• Humidity and temperature can adversely affect results

Materials Provided

1. Test devices 
2. Disposable specimen droppers 
3. Buffer 
4. Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection containers
• Lancets (for fingerstick whole blood only)
• Centrifuge (for plasma only)
• Timer
• Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)