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OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test

Customer Letter

ear Customer,

Thank you for deciding to use the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test. The sale, distribution, and use

of this product is restricted as described in the product insert. By purchasing this device, you are doing so as an agent

of a clinical laboratory and agree that you or any of your consignees will abide by the following restrictions on the

sale, distribution, and use of the device:

1. Sale of the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is restricted to clinical laboratories

• that have an adequate quality assurance program, including planned systematic activities to provide

adequate confidence that requirements for quality will be met

1-3

; and

• where there is assurance that operators will receive and use the instructional materials.

2. The OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is approved for use only by an agent of a clinical

laboratory.

3. Test subjects must receive the “Subject Information” pamphlet and pre-test counseling prior to specimen

collection, and appropriate counseling when test results are provided.

4. The OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test is not approved for use to screen blood or tissue donors.

The package insert for the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test contains warnings and precautions,

restrictions on the sale, distribution, and use of the device, and information about how the device works, how to use

the device, interpretation of results, and limitations of the procedure. The “Subject Information” pamphlet provides

subjects with information about the limitations of the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test and the

meaning of a preliminary positive or negative test result with the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test,

as well as general information about HIV and AIDS. You should review all of these materials yourself.

If you have any questions, please call us toll-free at 1-800-ORASURE (1-800-672-7873) or 1-800-869-3538 and ask

for customer service.

Sincerely,

OraSure Technologies’ Customer Service

References

1. CLSI Document GP2-A4, Clinical Laboratory Technical Procedure Manuals

2. CLSI Document GP27-A, Using Proficiency Testing (PT) to Improve the Clinical Laboratory

3. CLSI Document AST2-A, Point-of-Care In Vitro (IVD) Testing

220 East First Street, Bethlehem, PA 18015

Phone 610-882-1820

•

Fax 610-882-2275

www.orasure.com

3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 1

Summary of content (23 pages)

PAGE 1
3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 1 OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test Customer Letter Dear Customer, Thank you for deciding to use the OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test. The sale, distribution, and use of this product is restricted as described in the product insert.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 3 ADVANCE HIV-1/2 Read this package insert completely before using the product. Follow the instructions carefully when performing testing. Not doing so may result in inaccurate test results. 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.
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001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 4 issue by providing results during the initial visit and enabling immediate counseling. Additionally, for pregnant women who do not know their HIV status at the time of delivery, rapid HIV testing permits therapy to be initiated for these mothers during labor, and to their infants post partum, substantially reducing the chance that the infants will become infected with HIV.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 5 MATERIALS REQUIRED BUT NOT PROVIDED Timer or watch capable of timing 20 to 40 minutes Clean, disposable, absorbent workspace cover Biohazard waste container Additional items required for fingerstick and venipuncture whole blood collection, and plasma specimens: Antiseptic wipe Sterile lancet to obtain a fingerstick whole blood specimen, or materials required to obtain a venipuncture whole blood specimen Sterile gauze pads Latex, vinyl or nitrile d
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 6 STORAGE INSTRUCTIONS Store unused OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Tests unopened at 2°-27°C (36°-80°F). 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 (15°- 37°C, 59°- 99°F) before opening. DIRECTIONS FOR USE SET UP YOUR WORKSPACE • • • • • • Gather the materials you will need.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 7 STEP 2: TEST 1. Insert the Flat Pad of the Device all the way into the Vial (see picture 5A ). Make sure that the Flat Pad touches the bottom of the Vial. The Result Window on the Device should be facing towards you (see picture 6A ). 2. Start timing the test (see picture 7A ). DO NOT remove the Device from the Vial while the test is running. Pink fluid will appear and travel up the Result Window.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 8 2. Check the Solution to make sure that it appears pink. This means that the blood was correctly mixed into the Solution (see picture 10B ). If the Solution is not pink, discard all test materials in a biohazard waste container. Start the test over. Use a new Pouch and a new blood sample. STEP 3: TEST 1. Remove the Device from the Pouch. DO NOT touch the Flat Pad (see picture 11B ).
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 9 STEP 3: TEST 1. Remove the Device from the Pouch. DO NOT touch the Flat Pad (see picture 6C ). Check to make sure that an Absorbent Packet is included with the Device (see picture 7C ). If no Absorbent Packet is present, discard the Device and obtain a new Pouch for testing. 2. Insert the Flat Pad of the Device all the way into the Vial containing the blood sample (see picture 8C ). Make sure that the Flat Pad touches the bottom of the Vial.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 10 REACTIVE The diagrams at the right 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 a complete reddish-purple line appears next to the “T” triangle and next to the “C” triangle, no matter how faint these lines are.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 11 PERFORMANCE CHARACTERISTICS SENSITIVITY DETECTION OF ANTIBODIES TO HIV-1 IN SPECIMENS FROM INDIVIDUALS INFECTED WITH HIV-1 ORAL FLUID A sensitivity study was performed at eight clinical trial sites using freshly obtained oral fluid specimens collected from 767 individuals reported to be infected with HIV-1.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 12 FINGERSTICK WHOLE BLOOD A sensitivity study was performed at eight clinical trial sites using freshly obtained fingerstick whole blood samples from 481 individuals known to be infected with HIV-1 and 40 AIDS patients. Of the 521 specimens that were repeatedly reactive using a licensed EIA and positive by Western blot, 519 gave a reactive result on the OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test. The results of this study are shown in Table 3.
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11 4 10 32 35 38 36 74 45 55 49 33 36.22 6243 9015 9019 9032 9076 9077 9079 9084 12008 Average 13 12 10 10 3 9 9 4 8 9 5 14 4 4 3 970 14 959 70 11 947 6 9 969 20 945 33 103 939 2 19 7 934 3 5 968 27 933 967 27 926 5 7 12 44 Bleed 965 35 925 Day 924 Panel OraQuick ADVANCE ® 15070PL01 36.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 14 TABLE 5 Summary of the Delay in Days of Detection of Seroconversion Specimens with the ® OraQuick ADVANCE Rapid HIV-1/2 Antibody Test in Comparison to 3rd Generation anti-HIV EIA Tests Number of Panels Number of Concordant Results Number Detected Earlier by OraQuick Number Detected Earlier by EIA Average Days OraQuick Average Days EIA Delay Days (OraQuick - EIA) 23 7 3 13 36.46 34.99 1.48 (95% CI: -0.1 to 3.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 15 OQ ADVANCE ® OQ ADVANCE ® OQ ADVANCE ® LN 15070PL01 LN 6650009 LN 6650592 Abbott HIV 1/2 EIA Genetic Systems HIV 1/2 EIA Member Result Result Result s/co s/co 1 NR NR NR 4.1 >10.9 2 NR NR NR 0.7 >10.9 3 NR NR NR 0.6 8.5 4 R NR NR 2.1 >10.9 >10.9 Test Panel PRB 109 Bio-Rad HIV-1/ HIV-2 Plus O EIA s/co 5 R R R 18.4 6 NR NR NR 3.6 4.1 7 R R R 0.7 1.3 8 NR NR NR 0.1 0.1 9 R NR NR 2.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 16 TABLE 8 Performance of the OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test with Anti-HIV 2 Performance Panel OQ ADVANCE ® OQ ADVANCE ® OQ ADVANCE ® LN 15070PL01 LN 6650009 LN 6650592 Abbott HIV 1/2 EIA Genetic Systems HIV 1/2 EIA Bio-Rad HIV-1/ HIV-2 Plus O EIA Member Result Result Result s/co s/co s/co 1 R R R >8.9 2 R R R >8.9 3 R R R >8.9 4 R R R >8.9 5 R R R >8.9 6 R R R >8.9 7 R R R >8.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 17 As part of the oral fluid clinical studies, information was collected from the participants regarding concurrent diseases or medical conditions, oral pathologies, non-HIV viral infections, and other factors (e.g., use of tobacco products, mouthwash within 24 hours of testing, concomitant medications, dental fixtures, and food or drink immediately prior to testing).
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 18 SPECIFICITY ORAL FLUID A specificity study was performed at four clinical trial sites using freshly obtained oral fluid specimens collected from 605 previously unscreened individuals at low risk for HIV-1 infection. All of the 605 specimens were correctly non-reactive using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 19 FINGERSTICK WHOLE BLOOD A specificity study was performed at eight clinical trial sites using freshly obtained fingerstick whole blood samples from 1250 previously unscreened individuals at low risk for HIV-1 infection. In the course of this study, two specimens were confirmed to have antibodies to HIV-1 and were removed from the specificity calculation.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 20 TABLE 14 OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test Reactivity with Specimens from Individuals with Potentially Interfering Medical Conditions and Specimens with Interfering Substances OraQuick ADVANCE ® Results Reactive Non-Reactive Medical Condition (n = 321) 12 Multiparous women Anti-nuclear antibody (ANA) 0 Lupus 0 Rheumatoid factor 12 Cytomegalovirus (CMV) 0 12 Epstein Barr virus (EBV) 31 Hepatitis A virus (HAV) 12 Hepatitis B virus (H
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:11 PM Page 21 As part of the oral fluid clinical studies, information was collected from the participants regarding concurrent diseases or medical conditions, oral pathologies, non-HIV viral infections, and other factors (e.g., use of tobacco products, mouthwash within 24 hours of testing, concomitant medications, dental fixtures, and food or drink immediately prior to testing).
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:11 PM Page 22 BIBLIOGRAPHY 1. Gallo RC, Salahuddin SZ, Popovic M, et al. Frequent detection and isolation of cytopathic retroviruses (HTLV III) from patients with AIDS and at risk for AIDS. Science 1984; 224:500-3. 2. Curran JW, Morgan WM, Hardy AM, et al. The epidemiology of AIDS: current status and future prospects. Science 1985; 229:1352-7. 3. Clavel F, Guetard D, Brun-Vezinet F, et al.
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:11 PM Page 23 EXPLANATION OF SYMBOLS REF In Vitro Diagnostic Medical Device Batch Code IVD Catalog Number KIT CTRLS Kit Controls Caution, Consult Accompanying Documents Manufacturer Part Number CONTENTS Contents DEV SOL VIAL Developer Solution Vial Temperature Limitation HIV-1 CONTROL + HIV-1 Positive Control Use By HIV-2 CONTROL + HIV-2 Positive Control PN HIV CONTROL – 21 HIV Negative Control
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3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:11 PM Page 24 220 East First Street, Bethlehem, PA 18015 1- (800) ORASURE (800-672-7873) (610) 882-1820 www.OraSure.com Item #3001-1215 rev.