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General and Laboratory Considerations: Rapid HIV Tests Currently Available in the United States

February 14, 2007

Rapid HIV tests are simple to use and require little or no specialized equipment. They make it possible to provide test results at the time the test is done. Six rapid HIV tests approved by the U.S. Food and Drug Administration (FDA) are commercially available for use in the United States (listed in chronological order of their FDA approval dates):

  1. OraQuick Rapid HIV-1/2 Antibody Test
  2. Reveal G2 Rapid HIV-1 Antibody Test
  3. Uni-Gold Recombigen HIV Test
  4. Multispot HIV-1/HIV-2 Rapid Test
  5. Clearview HIV 1/2 Stat Pak
  6. Clearview Complete HIV 1/2
Test Kit Name Manufacturer Specimen Type CLIA
Category
Equipment Required
OraQuick Advance Rapid HIV-1/2 Antibody Test OrasureTechnologies,
Inc
Whole Blood,
Oral Fluid
Waived
 
Timer
Plasma Moderate
Complexity
Reveal G3 Rapid HIV-1 Antibody Test MedMira, Inc. Serum, Plasma Moderate
Complexity
Centrifuge,
Refrigerator
Uni-Gold Recombigen HIV Test Trinity BioTech Whole Blood Waived
 
Timer
Serum, Plasma Moderate
Complexity
Multispot HIV-1/HIV-2 RapidTest Bio-Rad Laboratories Serum, Plasma Moderate
Complexity
Centrifuge,
Refrigerator,
Lab Equipment
Clearview HIV 1/2 Stat Pak Inverness Medical Professional Diagnostics Whole Blood Waived Timer
Serum, Plasma Moderate
Complexity
Clearview Complete HIV 1/2 Inverness Medical Professional Diagnostics Whole Blood, Serum, Plasma Moderate
Complexity*
Timer

*Manufacturer has applied for waiver for use with whole blood.


Requirements for Performing Rapid HIV Tests

Any organization that performs a rapid HIV test in order to provide results to patients is considered a laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). All laboratories must comply with the regulations of the CLIA program and with applicable state requirements. (For more information on CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS), and a list of laboratory contact persons in each state, visit the CMS CLIA Web site. An organization can either apply for its own CLIA certificate or, if authorized by CMS, make arrangements to be included with a CLIA-certified laboratory under a multiple-site exception.

The sale of rapid HIV tests is restricted to clinical laboratories that have an adequate quality assurance program and where persons who use the test will receive and use the instructional materials provided with the tests. The FDA also requires that persons tested with the rapid tests receive the "Subject Information" pamphlet provided with the test. Details about other restrictions that apply to the rapid HIV tests are outlined in the package inserts provided with the test kits.

Currently available rapid HIV tests are either "waived" or categorized as "moderate complexity" under the CLIA program. CLIA requirements for laboratories differ depending on the category of the test. The Clearview (Chembio) tests have only recently been approved by the FDA and are not yet commercially available.

Waived Testing

OraQuick is a waived test when it is used with whole blood or oral fluids. Uni-Gold and Clearview HIV 1/2 Stat Pak are waived tests when used with whole blood. The manufacturer of Clearview COMPLETE HIV 1/2 test has applied for a CLIA waiver.

For waived tests, there are no federal requirements for personnel, quality assessment, or proficiency testing. Waived tests can be done in traditional laboratories or clinical settings and also in settings such as doctors' offices, HIV counseling and testing sites, mobile vans, and health fairs. To perform waived tests, an organization must obtain a certificate of waiver from the CLIA program (or, if authorized by CMS, be included with a CLIA-certified laboratory under a multiple-site exception) and follow the manufacturer's instructions for the test procedure. For laboratories that plan to perform waived testing, more information on CLIA requirements is outlined in the CLIA Certificate of Waiver Fact Sheet and at the CDC CLIA Web site. CDC also has developed guidelines on quality assurance practices for laboratories planning to use waived HIV rapid tests.

Moderate Complexity Testing

Reveal and Multispot are categorized as moderate complexity tests. OraQuick is categorized as moderate complexity when used with plasma. Uni-Gold, Clearview HIV Complete HIV 1/2, and Clearview HIV 1/2 Stat Pak are categorized as moderate complexity when used with serum or plasma.

A laboratory that performs moderate complexity tests must register with the CLIA program and meet specific CLIA standards for personnel, quality assessment, proficiency testing, and inspections. For organizations that plan to perform moderate complexity testing, more information on CLIA requirements and the steps necessary to obtain a certificate for moderate complexity testing are outlined in the moderate complexity overview section of the CDC CLIA Web site.


Summary of the Testing Procedures

OraQuick Advance Rapid HIV 1/2 Antibody Test

The OraQuick test is approved for use with whole blood specimens obtained by fingerstick or by venipuncture, with oral fluid specimens, and with plasma. It is intended for use at point of care, in medical and nonmedical settings. However, it can also be performed in a laboratory after the specimen has been obtained.

To conduct the test, place a vial of developer solution in the plastic stand. The reusable stand holds the test device at the correct angle to ensure accurate test results. When testing a fingerstick specimen, clean the fingertip with alcohol and prick the fingertip with a lancet (needle) to get a small drop of blood. The blood is collected with a specimen loop and transferred to a small plastic vial containing a premeasured volume of developing solution, into which the sample is mixed. The testing process is the same for whole blood or plasma obtained by venipuncture. For whole blood, insert the specimen loop into the tube of blood after the tube has been inverted to ensure that the blood is thoroughly mixed. For plasma, first centrifuge the blood to separate the blood cells from plasma, and insert the specimen loop into the plasma. Then insert the specimen loop into the test vial and mix. Collect oral fluid specimens by using the absorbent pad on the end of the test device to swab the outer surface of the upper and lower gums. Then insert the test device into the test vial. Test results must be read no sooner than 20 minutes, but no later than 40 minutes, after the OraQuick device is added to the developer solution.

The test result is read directly from the OraQuick device.

The OraQuick test includes an internal control that verifies that specimen has been added and that the test has been run correctly, Positive and negative external controls must be run by each new operator before performing testing on patient specimens, whenever a new lot of test kits is used, if the conditions of testing or storage (e.g., temperature) fall outside the range recommended by the manufacturer, and at periodic intervals specified in the laboratory's quality assurance program. External controls are not included with the test kits and must be ordered separately from the manufacturer.

Shelf Life of Kits: 6 months from data of manufacture if stored at room temperature

Shelf Life of Controls: 1 year unopened or 8 weeks after opening if refrigerated

For more information on the OraQuick test, see the test kit package insert or visit the manufacturer's Web site.

Reveal G3 Rapid HIV-1 Antibody Test

The Reveal G3 test is intended for use as a point-of-care test, but it requires some laboratory equipment. Positive and negative external controls (supplied with the test) must be reconstituted with buffer solution. These control reagents, each sufficient for 5 tests, can be stored refrigerated for up to 7 days after they are reconstituted.

To do the test, draw a blood specimen from a vein and centrifuge the specimen to separate the blood cells from the serum or plasma. Place a buffer solution in the test cartridge, and allow it to be absorbed. Add the serum or plasma specimen to the test cartridge and allow it to be absorbed. Then place the InstaGold cap in the cartridge and add 12 drops of buffer. Then remove the cap and read the test result directly from the cartridge. An additional 3 drops of buffer may be added to clarify the test results.

Unlike the Reveal test initially approved by the FDA, the Reveal G3 test contains an internal procedural control that verifies that the specimen has been added and the test has been run correctly. External controls (known HIV-positive and -negative specimens supplied with the test kit) must be run by each new operator before performing testing on patient specimens, whenever a new lot of test kits is used, if the conditions of testing or storage (e.g., temperature) fall outside the range recommended by the manufacturer, and at periodic intervals specified in the laboratory's quality assurance program.

Shelf Life: Information pending

For more information on the Reveal G3 test, see the test kit package insert or visit the manufacturer's Web site.

Uni-Gold Recombigen HIV

The Uni-Gold test is a single-use rapid test for the detection of HIV-1 antibodies in plasma, serum, or anticoagulated whole blood obtained by fingerstick or venipuncture. It is intended for use as a point-of-care test.

To conduct the test, draw an adequate specimen (serum, plasma, or whole blood) to the first gradation on the pipette supplied with the kit, or obtain a fingerstick blood specimen with the pipette supplied for this purpose. Hold the pipette vertically over the sample port and add 1 drop of specimen. Add 4 drops of the wash solution from the dropper bottle to the sample port. Set timer for 10 minutes.

The test result is read directly from the device 10 to 12 minutes after the specimen is added.

The Uni-Gold test includes an internal control that indicates whether the test is functioning correctly. However, the formation of the control line on the Uni-Gold test does not validate that the specimen has been added to the test. Consequently, a test with no specimen added may appear the same as a test with a negative result (that is, a band in the control region and no band in the test region). When testing whole blood, you must observe the red color at the specimen sample port to validate that specimen was added. Positive and negative external controls should be run by each new operator before performing testing on patient specimens, whenever a new lot of test kits is used, if the conditions of testing or storage (e.g., temperature) fall outside the range recommended by the manufacturer, and at periodic intervals specified in the laboratory's quality assurance program. External controls are not included with the test kits and must be ordered separately from the manufacturer. The controls require refrigeration and can be stored for 21 days after they are opened.

Shelf Life of Kits: 1 year from date of manufacture if stored at room temperature

For more information on the Uni-Gold test, see the test kit package insert or visit the manufacturer's Web site.

Multispot HIV-1/HIV-2 Rapid Test

The Multispot test is a single-use rapid test that detects and differentiates circulating antibodies to HIV types 1 and 2 in fresh or frozen human serum and plasma. It has been approved by FDA to differentiate HIV-1 from HIV-2 antibodies. Multispot requires a refrigerator for the reagents and some laboratory equipment for processing and diluting the specimen.

To conduct the test,

The test result is read directly from the device at any time after the test is completed.

Shelf Life of Kits: 1 year refrigerated, 3 months at room temperature

For more information on the Multispot test, see the test kit package insert or visit the manufacturer's Web site.

ClearView HIV 1/2 Stat Pak

The Clearview HIV 1/2 Stat Pak is a single-use rapid test that detects antibodies to HIV-1 and HIV-2 in fingerstick whole blood, venous whole blood, serum, or plasma specimens. The Clearview HIV 1/2 Stat Pak assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 or HIV-2.

To conduct the test,

The test result is read directly from the device.

Shelf Life of Kits: 24 months from the date of manufacture if stored at room temperature

For more information on the Clearview HIV 1/2 Stat Pak, see the test kit package insert or visit the manufacturer's Web site.

ClearView Complete HIV 1/2

The Clearview Complete HIV 1/2 (formerly known as the Sure Check HIV 1/2) is a single-use rapid test that detects antibodies to HIV-1 and HIV-2 in fingerstick whole blood, venous whole blood, and serum or plasma specimens. It is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 or HIV-2. The shape of the device resembles a syringe with a narrow sampler tip and the test strip enclosed in the barrel. The single-use vial of buffer is stored in the base of the barrel.

To conduct the test,

The test result is read directly from the device.

Shelf Life of Kits: 24 months from the date of manufacture if stored at room temperature

For more information on the Clearview Complete HIV 1/2, see the test kit package insert or visit the manufacturer's Web site.


Interpretation of Rapid HIV Test Results

The results of rapid HIV tests are interpreted the same way as the results of other HIV screening tests.

Special Note: Specimens from HIV-infected persons receiving highly active antiretroviral therapy may produce false-negative results on rapid tests.

For more information see CDC's Revised Counseling, Testing, and Referral Guidelines.




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