D35 ORAQUICK ADVANCE RAPID HIV TEST.pdf

PATHOLOGY & LABORATORY MEDICINE SERVICE

4300 West 7 th

Street, Little Rock, AR 72205

Issue Date:

07/13/16

Document # :

CBOC.009

Owner: Karen McNulty Revision:

Primary Approver: Kim Rose, Lab Manager

Document Status: Approved for Operational Use - Not Document Controlled if Printed

Title: ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST

PURPOSE

The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in venipuncture whole blood and plasma specimens, fingerstick whole blood, and oral fluid.

PRINCIPLE

The OraQuick ADVANCE™ Rapid HIV-1/2 Antibody Test is a manually performed, visually read, 20 minute immunoassay for the qualitative detection of antibodies to HIV-

1 and HIV-2 in whole blood or plasma. The OraQuick ADVANCE rapid test is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer solution. Each component is sealed in separate compartments of a single pouch to form the test. The OraQuick ADVANCE rapid test utilizes a proprietary lateral flow immunoassay procedure. The device plastic housing holds an assay test strip comprised of several materials that provide the matrix for the immunochromatography of the specimen and the platform for indication of the test results.

The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the HIV envelope region and a goat anti -human IgG procedural control immobilized onto a nitrocellulose membrane in the Test

(T) zone and the Control (C) zone, respectively.

A whole blood specimen is collected and transferred into the vial of developer solution, followed by the insertion of the test device. The developer solution facilitates the flow of the specimen into the device and onto the test strip. As the diluted specimen flows through the device, it rehydrates the protein-A gold colorimetric reagent contained in the device. As the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The intensity of the line color is not directly proportional to the amount of antibody present in the specimen.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies to HIV-1 and/or HIV-2.

The test results are interpreted after 20 minutes but not more than 40 minutes after the introduction of the test device into the developer solution containing the test specimen.

No precision pipeting, pre-dilutions, or specialized instrumentation are required to perform the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.

EQUIPMENT AND REAGENTS

MATERIALS PROVIDED

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Kits are available in the following packaging configurations:

Kit Size 100 count 25 count

Divided pouches, each containing:

Test Device (1)

Absorbent Packet (1)

Developer Solution Vial

(1)

(each vial contains 1 mL of a phosphate buffered saline solution containing polymers and an antimicrobial agent) th

Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

Reusable Test Stands 10 5

Specimen Collection Loops 100 25

Subject Information

Pamphlets

100 25

Package Insert 1 1

Customer Letter 1 1

Note: Due to low volume of tests performed for exposure in the CBOCs, the CBOC laboratory will have 2 test pouches on hand. Tests will be replenished as needed, supplied by the CAVHS Microbiology Laboratory.

MATERIALS REQUIRED AND AVAILABLE AS AN ACCESSORY TO THE KIT

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Kit Controls

Package contains:

HIV-1 Positive Control (1 vial, black cap, 0.2 mL)

HIV-2 PositiveControl 1 vial (1 vial, red cap, 0.2 mL)

Negative Control (1 vial, white cap, 0.2 mL)

MATERIALS REQUIRED BUT NOT PROVIDED

Timer or watch capable of timing 20 to 40 minutes

Biohazard waste container

STORAGE INSTRUCTIONS

Store unused OraQuick ADVANCE Rapid HIV-1/2 Antibody Tests unopened at 2o-27ºC (35-80oF).

Do not open the Divided Pouch until you are ready to perform a test.

If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature (15o-37oC, 59o-99oF) before opening.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

SPECIMEN/SAMPLE

Whole blood (collected in EDTA-lavender top). Other anticoagulants have not been tested and may give an incorrect result. Whole blood is the only sample being used for testing with this method in the CBOC laboratories.

Whole blood that is not used right away may be stored at 2-30ºC (35-86ºF) for up to 5 days. Prior to testing whole blood, mix the blood tube gently by inversion to ensure a homogeneous sample.

PRELIMINARY TO TESTING: Refer to Memorandum No. 111-4: Medical Center

Exposure Plan for Blood borne Pathogens for more information regarding this procedure. Testing for Rapid HIV in the CBOC laboratories will be performed during clinic hours, Monday-Friday only to ensure that any Blood borne exposures to CBOC staff can be processed in a timely manner. Information below referring to testing after hours and weekends will not apply to CBOC laboratory personnel.

1. Medical Center personnel, including personnel at the CBOC are to report needle sticks, splash and sharps injuries as soon as possible to their immediate supervisor and then to Employee Health (LR & NLR) during regular working hours, or to the emergency room during irregular hours, on holidays or on weekends. In NLR contact the MOD/NOD irregular hours, holidays, weekends.

2. The Employee Health Nurse, or designee(s), shall notify the source patient’s primary physician, or designee, of the exposure. (Irregular hours, holidays, or weekends: Little Rock-the ER will notify the physician; NLR-the MOD/NOD is responsible for notification of the physician.)

3. The source patient will be informed by the designated clinical staff of the incident. Hepatitis B surface antigen and Hepatitis C antibody tests are ordered on the source patient in accordance with Public Health guidelines. HIV blood testing will only be ordered on the source patient AFTER the patient has been counseled in accordance with guidelines in the Under Secretary for Health’s Information Letter 10-2001-01.

4. After counseling of the source patient, the consent form will be signed and placed in the patient’s chart. (The consent form is not available electronically.) It is not necessary that the lab see this form.

5. The rapid HIV test is available 24 hours/7 days a week. Employee Health, Infection Control, Emergency Room personnel, or the NLR MOD/NOD will notify the lab (7:00am-4:30pm Mon-Fri & 7:00am-3:30pm weekends & holidays, call Microbiology, ext. 56457, 56458, or 56459; 4:30pm-7:00am th

Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager weekdays & 3:30pm-7:00am weekends & holidays, call 76455) of the employee exposure and order the Rapid HIV test in the computer. If the source patient already has blood in the lab, it can be used for testing. If not, a sample should be drawn.

6. The rapid HIV testing for the source patient will be available at the all VA Staffed

CBOC laboratories during clinic hours, Monday-Friday. All other testing related to the exposure will be drawn at the CBOC laboratory and transported with the samples being tested at the Little Rock laboratory via lab courier system.

POST TESTING:

1. Rapid HIV is a Critical Test and results (both positive and negative) must be called to Infection Control or Employee Health, 7:00am-4:30pm, weekdays.

The provider receiving the result must read the result back. Document in the computer who you gave the result to, the date & time, your initials and *RBC.

He/she will inform the employee of the results and offer treatment, if necessary. For Positive/Reactive test results, document in the comment section of the result “Multispot, HIV analysis will be performed for confirmation”) in report along with who you gave the result to, date & time, your tech initials and *RBC.

Positive results should also be printed to Infection Control printer PT63092.

2. Positive results must be confirmed by Multispot. This is a send out test, it requires serum that has been removed from its clot within 3 hours of collection. Specimen should be sent to the Client Services, Room 2D162 at the Little Rock laboratory with a completed computer downtime form requesting it be sent out for Multispot, HIV.

3. Antiretroviral prophylaxis, if taken, should be initiated within 1 or 2 hours of exposure, and no longer than 36 hours.

4. Follow-up testing on the employee will be done at 12 weeks and 6 months.

SPECIAL SAFETY PRECAUTIONS

WARNINGS

For in vitro Diagnostic Use

1. Read the package insert completely before using the product. Follow the instructions carefully. Not doing so may result in inaccurate test results.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

2. Before performing testing, all operators MUST read and become familiar with Universal Precautions for Prevention of Transmission of Human

Immunodeficiency Virus, Hepatitis B Virus, and other Blood-borne Pathogens in Health-Care Settings.

3. FDA has approved this kit for use with oral fluid, fingerstick whole blood, venipuncture whole blood, and plasma specimens only. Use of this test kit with specimen types other than those specifically approved for use with this device may result in inaccurate test results.

4. This test should be performed at temperatures in the range of (15o-37oC, 59o-99oF). If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature (15o-37oC, 59o-99oF) before performing testing.

5. If the test kit is stored at temperatures outside of ambient temperature (2o-

27oC, 35o-80oF), or used outside of operating temperature (15o-37oC, 59o- 99oF), use the Kit Controls to ensure performance of the test.

6. Individuals infected with HIV-1 and/or HIV-2 who are receiving highly active antiretroviral therapy (HAART) may produce false negative results.

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. Dispose of all test specimens and materials used in the test procedure in a biohazard waste container.

5. Wipe all spills thoroughly with a solution of amphyll or other appropriate disinfectant.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

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. Adequate lighting is required to read a test result.

PERSONAL PROTECTIVE EQUIPMENT

Lab coat/Gloves

PROCEDURE

1. Open the two chambers of the OraQuick ADVANCE Divided Pouch (“Pouch”) by tearing at the notches on the top of each side of the Pouch. To prevent contamination, leave the Test Device (“Device”) in the Pouch until you are ready to use it.

2. Remove the Developer Solution Vial (“Vial”) from the Pouch. Hold the Vial firmly in your hand. Carefully remove the cap from the Vial by gently rocking the cap back and forth while pulling it off. Set the cap on the counter.

3. Slide the Vial into the top of one of the slots in the Stand. DO NOT force the vial into the Stand from the front of the slot as splashing may occur. Make sure the

Vial is pushed all the way to the bottom of the slot in the stand.

NOTE: DO NOT cover the two holes in the back of the Device with labels or other materials. Doing so may cause an Invalid result.

4. Pick up an unused Specimen Collection Loop (“Loop”) by the thick “handle” end.

Put the “rounded” end of the Loop into the tube of blood/plasma. Make sure that the Loop is completely filled with blood.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

NOTE: If the Loop is dropped or comes in contact with any other surface, discard it in a biohazard waste container. Get a new Loop for the collection of the blood sample.

5. Immediately insert the blood-filled end of the Loop all the way into the Vial. Use the Loop to stir the blood/plasma sample in the Developer Solution (“Solution”).

Remove the used Loop from the Solution. Throw the used Loop away in a biohazard waste container.

6. When testing whole blood, check the Solution to make sure that it appears pink. This means that the blood was correctly mixed into the Solution. If the

Solution is not pink, discard all test materials in a biohazard waste container.

Start the test over. Use a new Pouch and collect a new blood sample.

7. Remove the Device from the Pouch. DO NOT touch the Flat Pad. Check to make sure that an Absorbent Packet is included with the Device. If no Absorbent

Packet is present, discard the Device and obtain a new Pouch for testing.

8. Insert the Flat Pad of the Device all the way into the Vial containing the blood/plasma sample. Make sure that the Flat Pad touches the bottom of the

Vial. The Result Window on the Device should be facing towards you.

9. Start timing the test. DO NOT remove the Device from the Vial while the test is running. Pink fluid will appear and travel up the Result Window. The pink fluid will gradually disappear as the test develops. Read the results after 20 minutes but not more than 40 minutes in a fully lighted area.

GENERAL TEST CLEAN-UP

1. Dispose of the used test materials in a biohazard waste container.

2. When using gloves, change your gloves between each test to prevent contamination. Throw away the used gloves in a biohazard waste container.

3. Use a freshly prepared 10% solution of bleach to clean up any spills.

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Street, Little Rock, AR 72205

Primary Approver: Kim Rose, Lab Manager

TEST RESULT AND INTERPRETATION OF TEST RESULT

Refer to the Result Window on the Test Device.

NON-REACTIVE

The diagram below shows an example of a Non-Reactive test result.

A test is Non-Reactive if:

A reddish-purple line appears next to the triangle labeled “C”, and NO line appears next to the triangle labeled “T”.

A Non-Reactive test result means that HIV-1 and HIV-2 antibodies were not detected in the specimen. The test result is interpreted as NEGATIVE for HIV-1 and HIV-2 antibodies.

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Primary Approver: Kim Rose, Lab Manager

REACTIVE

The diagrams below show examples of a Reactive test result.

A test is Reactive if:

A reddish-purple line appears next to the triangle labeled “C” and a reddish-purple line appears next to the triangle labeled “T”. One of these lines may be darker than the other.

NOTE: The test is Reactive if any reddish-purple line appears next to the “T” triangle and next to the “C” triangle, no matter how faint these lines are.

A Reactive test result means that HIV-1 and/or HIV-2 antibodies have been detected in the specimen. The test result is interpreted as PRELIMINARY POSITIVE for HIV-1 and/or HIV-2 antibodies.

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Primary Approver: Kim Rose, Lab Manager

INVALID

The diagrams below show examples of an Invalid test result.

A test is Invalid if any of the following occurs:

NO reddish-purple line appears next to the triangle labeled “C”, or a red background in the Result Window makes it difficult to read the result after 20 minutes, or if any of the lines are NOT inside the “C” or “T” triangle areas

An Invalid test result means that there was a problem running the test, either related to the specimen or to the Test Device. An Invalid result cannot be interpreted.

Repeat the test with a new Divided Pouch and a new whole blood or plasma, sample. Contact OraSure Technologies’ Customer Service (800-672-7873 or 800-

869-3538) if you are unable to get a valid test result upon repeat testing.

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Primary Approver: Kim Rose, Lab Manager

LIMITATIONS OF THE TEST

1. The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test must be used in accordance with the instructions in this package insert to obtain an accurate result.

2. Reading test results earlier than 20 minutes or later than 40 minutes may yield erroneous results.

3. This test is approved by FDA for use with oral fluid, fingerstick whole blood, venipuncture whole blood, and plasma specimens only. Use of other types of specimens, testing of venipuncture whole blood specimens collected using a tube containing an anticoagulant other than EDTA, sodium heparin, or sodium citrate, or testing of plasma specimens collected using a tube containing an anticoagulant other than EDTA may not yield accurate results.

4. Individuals infected with HIV-1 or HIV-2 who are receiving highly active antiretroviral therapy (HAART) may produce false negative results.

5. Clinical data has not been collected to demonstrate the performance of the

OraQuick ADVANCE Rapid HIV-1 Antibody Test in persons under 12 years of age.

6. A reactive result using the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test suggests the presence of HIV-1 and/or HIV-2 antibodies in the specimen. The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically.

7. For a reactive result, the intensity of the test line does not necessarily correlate with the titer of antibody in the specimen.

8. A non-reactive result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure may take several months to reach detectable levels.

9. A person who has antibodies to HIV-1 or HIV-2 is presumed to be infected with the virus, except that a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.

Clinical correlation is indicated with appropriate counseling, medical evaluation and possibly additional testing to decide whether a diagnosis of HIV infection is accurate.

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Primary Approver: Kim Rose, Lab Manager

QUALITY CONTROL

Internal Quality Control:

The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test has a built-in procedural control that demonstrates assay validity. A reddish-purple line in the Control (“C”) area of the

Result Window indicates that a specimen was added and that the fluid migrated appropriately through the Test Device. The Control line will appear on all valid tests, whether or not the sample is reactive or non-reactive. Internal quality control results for each test run will be recorded on the corresponding order sheet as follows:

“QC acceptable” or “QC ok”, along with the date and the technologist/technician initials. See form linked to this document.

External Quality Control:

Note: External QC will be performed by Microbiology laboratory at the CAVHS

Little Rock for the following situations. A copy of the documentation of the control results will be kept on file for each allotment of tests shipped to the CBOC laboratory.

Performed with each new lot/shipment

Performed if the temperature of the test kit storage area falls outside of 2º- 27ºC (35º-80ºF)

Performed if the temperature of the testing area falls outside of 15º-37ºC (59º-99ºF)

External quality control results will be on file at the CBOC laboratory.

Entering Results into VISTA:

To expedite the availability of the Rapid HIV testing for the CBOC staff in event of a bloodborne exposure, at this time the results will be entered under the

Microbiology menu. When the test menus are available for each CBOC, this procedure will be revised.

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Primary Approver: Kim Rose, Lab Manager

Steps to enter results:

1. From the Laboratory Main Menu, Select option #3 (Process data in lab menu)

2. Select EM (Enter/verify/modify data manual)

3. Accept defaults until you reach the option to verify by Accession number or UID.

Either option can be used to enter the data.

4. Accession to enter under is M-SER.

5. Select the correct date and performing laboratory (at this time use the default- Central Arkansas HCS)

6. Enter Microbiology as the Workload

7. Enter the Accession number to be resulted- this test is resulted out as Negative or Positive.

Document in the comment section the testing location and address.

8. Document the provider notified of the result, the date and time of notification, tech initials and the canned comment *RBC (Read back and confirmed). See pg.

5 of this procedure for further instructions about notifying provider.

9. For Positive/Reactive test results, document in comment section “Multispot, HIV analysis will be performed for confirmation”) See pg. 5 of this procedure for further instructions about confirmation test.

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Kit Controls are available separately for use only with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. The Kit

Controls are specifically formulated and manufactured to ensure performance of the

Test, and are used to verify your ability to properly perform the test and interpret the results. The HIV-1 and HIV-2 Positive Controls will produce a reactive test result and have been manufactured to produce a very faint Test (“T”) line. The Negative Control will produce a non-reactive test result. Use of kit control reagents manufactured by any other source may not produce the required results, and therefore, will not meet the requirements for an adequate quality assurance program for the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test.

REFERENCES

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test package insert, revised 09/12 th

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Primary Approver: Kim Rose, Lab Manager

PATIENT CONFIDENTIALITY

This department is required to follow all patient and privacy release of information policies as established in MCM 136-4 “Privacy and Release of Information”.