Orasure OraQuick Advance HIV Detection Test Kit

Features of Oraquick HIV Test

• Rapid:
  Provides results in 20 minutes enabling patients to learn their status in a single visit and allows HIV-positive patients to be connected to care immediately.
• Flexible:
  Approved for oral fluid, plasma, fingerstick, or venipuncture whole blood specimens. Ideal for both clinical and non-clinical settings.
• Accurate:
  Greater than 99% agreement with confirmatory Western blot.
• Simple:
  CLIA-waived for oral fluid, fingerstick, and venipuncture whole blood and offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics. The walk-away procedure allows providers to batch tests, enabling more people to get tested, reducing indirect costs and improving turnaround time.
• Reliable:
  Offers patients accurate HIV testing without the need for blood or needles. Pain-free testing with oral fluid means more people get screened, more HIV positive patients are connected to care and fewer people are exposed.

Oraquick Instruction Manual

What to buy with Oraquick In-Home HIV Test

• Stress Stop Biodots Skin Thermometer
• Eko DUO ECG + Digital Stethoscope
• B&L Pinch Gauge

Safety and Handling Precautions

Safety Precautions

1. Handle blood specimens and materials contacting blood specimens as if capable of transmitting infectious agents.
2. Do not drink, eat, or smoke in areas where specimens are being handled or testing is being performed
3. Wear disposable gloves while handling blood specimens and performing testing of blood specimens. Change gloves and wash hands thoroughly after performing each test. Dispose of used gloves in a biohazard waste container
4. Oral fluid is not considered potentially infectious unless it contains blood.8 Use of gloves for oral fluid testing is optional. Test administrators with breaks in the skin (cuts, abrasions, or dermatitis) should wear gloves when performing oral fluid testing. Wash hands thoroughly after performing each oral fluid test and after contact with oral fluid
5. Dispose of all test specimens and materials used in the test procedure in a biohazard waste container. Lancets and venipuncture materials should be placed in a puncture-resistant container prior to disposal. The recommended method of disposal of biohazard waste is autoclaving for a minimum of 1 hour at 121°C. Disposable materials may be incinerated. Liquid wastes may be mixed with appropriate chemical disinfectants. A freshly prepared solution of 10% bleach (0.5% solution of sodium hypochlorite) is recommended. Allow 60 minutes for etfective decontamination.
NOTE: Do not autoclave solutions that contain bleach.
6. Wipe all spills thoroughly with a solution of 10% bleach or other appropriate disinfectant. Bleach solutions should be made fresh each day.

Handling Precautions

1. Use all Specimen Collection Loops, Test Devices, and Developer Solution Vials only once and dispose of properly (see Safety Precautions). Do not reuse any of these test components
2. Do not use the test beyond the expiration date printed on the Divided Pouch. Always check expiration date prior to testing
3. Do not interchange Test Devices and Developer Solution Vials from kits with different lot numbers
4. Avoid microbial contamination and exercise care in handling the kit components
5. To ensure accurate results, the Test Device must be inserted into the Developer Solution Vial within 60 minutes after introducing the fingerstick whole blood, venipuncture whole blood or plasma sample
6. When collecting oral fluid specimens the Test Device must be inserted into the Developer Solution Vial within 10 minutes of collection
7. Adequate lighting is required to read a test result

Oraquick In-Home HIV Test FAQ's

Is OraQuick accurate after 20 minutes?
The OraQuick test takes 20 minutes to develop. The test results are accurate for 40 minutes in total. This means you need to read the test results within 40 minutes of placing the test stick in the test tube. After 40 minutes, the test stick may overdevelop, causing an incorrect test result.

Can you drink water before the Rapid HIV Test?
Don't eat, drink (even water), smoke, chew gum, or use oral care products (e.g., toothpaste) for 30 minutes before taking the test. If you test positive, you need a follow-up test from a health care provider or at an HIV testing site.

How early can OraQuick detect HIV?
The new 4th generation test can usually detect HIV within 2 weeks.

Is the Oraquick HIV Test accurate?
As noted in the package insert, clinical studies have shown that the OraQuick In-Home HIV Test has an expected performance of approximately 92% for test sensitivity (i.e., the percentage of results that will be positive when HIV is present).