Quality Assurance Guidelines for Testing Using the 

OraQuick® Rapid HIV-1 Antibody Test 

U.S. Department of Health and Human Services 

Centers for Disease Control and Prevention 

Use of trade names and commercial sources is for identification only and does not imply endorsement by 

the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services. 
The following CDC staff members prepared this report: 

Devery Howerton, Ph.D. 

 Thomas L. Hearn, Ph.D. 

Division of Laboratory Systems 

Public Health Practice Program Office 

Ida M. Onorato, M.D. 

Bernard M. Branson, M.D. 

Naomi Bock, M.D. 

Division of HIV/AIDS Prevention 

National Center for HIV, STD and TB Prevention 

Jonathan E. Kaplan, M.D. 

Mark A. Rayfield, Ph.D. 

Division of AIDS, STD, and TB Laboratory Research 

National Center for Infectious Diseases 

in consultation with 

Elliot Cowan, Ph.D. 

Steven I. Gutman, M.D. 

Food and Drug Administration 

Rockville, MD 

Carlyn Collins, M.D. 

Eileen Burke 

Public Health Practice Program Office and National 

Center for HIV, STD and TB Prevention, CDC

Nelson Michael, M.D., Ph.D. 

United States Army 

Walter Reed Army Institute of Research

Rockville, MD

Judy Yost 

Valerie Coppola 

Centers for Medicare & Medicaid Services 

Baltimore, MD 

Chris Alderidge 

National Alliance of State and Territorial AIDS 

Directors 

Washington, D.C. 

Catherine Johnson, M.T. 

COLA 

Columbia, MD

Patricia Charache, M.D. 

Johns Hopkins Medical Institutions 

Baltimore, MD 

Liisa Randall, Ph.D. 

Michigan Dept. of Community Health 

Okemos, MI 

Jane Getchell, Dr. PH 

Delaware Public Health Laboratory 

Smyrna, DE 

Karen Kroc 

Cook County Bureau of Health Services 

Chicago, IL

Gregg Gonsalves 

Gay Men's Health Crises 

New York, NY

Belinda Yen-Lieberman, PhD 

Cleveland Clinic 

Cleveland, Ohio

Patrick Keenan, M.D. 

University of Minnesotta 

Minneapolis, MN 

Marlene LaLota, MPH 

Florida Department of Health 

Tallahassee, FL

QA Guidelines for OraQuick 1 
Introduction and Background 

Purpose This document provides guidance on quality assurance (QA) practices for sites 

using or planning to use the OraQuick® Rapid HIV-1 Antibody Test to detect 

antibodies to the human immunodeficiency virus (HIV).

Background The OraQuick Rapid HIV-1 Antibody Test is the first rapid HIV point-of-care 

(i.e., testing and results are available in one visit) test approved by the U.S. Food 

and Drug Administration (FDA). It is also the first test for HIV that the FDA has 

waived under the Clinical Laboratory Improvement Amendment regulations 

(CLIA). The OraQuick test uses whole blood obtained from puncture of a finger. 

Results are available within 20 to 60 minutes.1

 Positive results with the OraQuick 

rapid test are preliminary, however, and must be followed up with an acceptable

confirmatory test. Although the OraQuick test device is simple to use and can 

provide reliable results when the manufacturer’s directions are followed, mistakes

can occur at any point in the testing process. To reduce mistakes and to ensure 

that the FDA restrictions for sale of the test are followed (see Appendix A for 

information on the FDA sales restrictions), a site must have a QA program in 

place before offering OraQuick testing. The guidelines in this document outline 

the basic parts of a QA program. 

How these 

guidelines were 

developed 

These guidelines were developed after many discussions on quality assurance for 

rapid HIV testing within the Centers for Disease Control and Prevention (CDC) 

and culminated from the discussions at a meeting of experts convened by the 

CDC at the end of January 2003. This working group included individuals from

Federal agencies—CDC, FDA, U.S. Department of Defense (DOD), and the 

Centers for Medicare & Medicaid Services (CMS)—as well as individuals outside 

the Federal government with expertise in rapid point-of-care testing, QA, HIV 

prevention programs, and private and public health laboratories. 

How to use these 

guidelines 

This document outlines the basic processes and procedures that should be in place 

before a site offers rapid HIV testing. It describes steps that can be taken to 

identify and prevent errors in the testing process. Because the OraQuick test will 

be used in many different settings, each site needs to decide how to fit the various 

QA elements into its own workflow and system of operation. For example, 

following these guidelines in a large clinic or hospital environment where on-site

laboratory support is available may be quite different from using them in a small 

voluntary counseling and testing site or outreach setting with few staff and 

resources. These guidelines are intended to assist a range of providers in 

developing policies, processes and procedures to ensure high quality HIV testing 

services. 

 

How this document 

is organized

This document includes text and appendices that provide basic information that 

staff in sites offering OraQuick testing should know. It includes information on:







The basics of a QA program for testing using the OraQuick test. 

An overview of government rules that apply to using this test. 

Examples of forms/checklists that can be used to keep track of QA outcomes. 

QA Guidelines for OraQuick 2 
Basic Elements of a Quality Assurance Program

What is quality 

assurance? 

Quality assurance (QA) refers to planned, step-by-step activities that let one know 

that testing is being carried out correctly, results are accurate, and mistakes are 

found and corrected to avoid adverse outcomes. Quality assurance is an ongoing 

set of activities that help to ensure that the test results provided are as accurate and 

reliable as possible for all persons being tested. Quality assurance activities should 

be in place during the entire testing process; this means from the time a person 

asks to be tested using the rapid HIV test to providing the test result. 

How does quality 

assurance differ 

from quality 

control? 

As described above, QA is an overall program of activities throughout the entire 

testing process. Quality control (QC) is one part of the QA program. See page 11 

for details on quality control testing for the OraQuick test. Here are definitions 

for both terms2

: 

Term Definition and activities performed 

Quality assurance Planned and organized activities to help ensure that 

certain requirements for quality will be met 

Quality control Operational techniques or tasks that are in place to 

find and correct problems that might occur 

Basic elements of a 

QA program for 

OraQuick Rapid 

HIV-1 Antibody 

testing 

Even though the OraQuick test is simple to use, things can go wrong. To help 

find and prevent problems, the basic elements of a QA program should be in place 

before offering testing. These basic elements are the building blocks of a QA 

program and are listed below. More detail on these five elements is provided in 

this document. 

1.Organization of the QA program

2.Testing personnel 

3.Process control 

a.Before testing 

b.During testing 

c. After testing 

4.Documents and records 

5.Troubleshooting 

QA Guidelines for OraQuick 3 
Organization of the QA program 

Establishing a QA 

program

Resources are needed to establish and maintain a QA program, no matter how 

simple. Someone must oversee the program and ensure the necessary staff and 

supplies are available. Each organization must: 













Identify the person(s) responsible for managing the QA program (this could 

be a senior staff member, outside consultant or a network of individuals who 

oversee different aspects of the QA program). 

Write procedures (step-by-step instructions) and make them available to all 

staff involved in testing (see the list of recommended procedures below). 

Verify the testing process (see below). 

Ensure staff know how to perform processes and procedures (see the section 

on personnel who conduct testing on page 6). 

Create mechanisms for communication so that those who need to know are 

informed about QA issues, as well as all staff, when appropriate. 

Develop and implement mechanisms to ensure the site meets all applicable 

Federal, State, and other regulatory requirements. Each site offering testing 

must have a CLIA Certificate of Waiver if they are performing only the 

OraQuick test or the OraQuick test and other waived tests, or be included 

under an organization with a CLIA exception for limited public health or 

mobile testing. Each site must also meet Federal requirements for biohazard 

safety, as well as applicable State rules. See Appendix A for more 

information on regulatory requirements. 

Verifying the 

testing process 

Before offering the test to clients or patients, each site should make sure (verify) 

that the testing process works as planned. This verification should be completed 

before testing is offered. Verification includes ensuring that staff have been 

trained and are able (competent) to perform their assigned tasks, the test kits work 

as expected (e.g., make sure the test gives accurate results for a referenced panel 

of non-reactive, weakly reactive and reactive specimens), and the logistics for 

providing confirmatory testing (if a person tests positive, he or she still has to 

have a test to confirm the finding) and biohazardous waste handling are in place. 

QA Guidelines for OraQuick 4 
QA Guidelines for OraQuick 5 































Organization of the QA program (continued) 

Providing written 

procedures 

It is strongly recommended that step-by-step, written instructions be made 

available to all staff performing testing. This will help to ensure that personnel 

know how to perform specific tasks and testing success is not left to chance. 

Testing personnel must follow instructions provided by the manufacturer. 

Additional procedures, as listed below, should be provided along with the 

manufacturer’s instructions. Text from the current OraQuick package insert may 

be used for some of the items denoted by an asterisk (*) in the list below. Written 

instructions should describe how to: 

Train new employees, assess their ability to do the testing and document 

training. 

Provide information to persons being tested before testing.* 

Use gloves and other personal protective equipment.

Safely dispose of biohazardous waste, including used lancets. 

Maintain sufficient supplies and unexpired test and control kits, follow the 

manufacturer’s instructions for storage, and check performance of new test kit 

lots and shipments with external controls as explained on page 10.

Maintain and document the temperature of the room and refrigerator where 

the tests and controls are stored and testing is performed.

Perform quality control testing and take action (e.g., contact the manufacturer) 

if controls don’t work.

Collect the OraQuick specimen. * 

Perform steps in the test procedure. * 

Report results. 

Refer specimens or persons being tested for confirmatory testing and manage

confirmatory test results. 

Record test and quality control results. 

Conduct external quality assessment (see description on page 15) 

Review records and store and destroy them when they are outdated (how long 

test result records are kept as part of a medical record may be subject to State 

or other requirements). 

Troubleshoot and take corrective action when things go wrong.
QA Guidelines for OraQuick 6 







Testing Personnel 

Overview Having qualified, trained staff to perform and supervise OraQuick testing and the 

various activities in the QA program is one of the most important factors for 

ensuring accurate and reliable results. Key aspects of this element include: 

Qualifications 

Training 

Competency assessment (i.e., how well they are doing their job)

Personnel 

qualifications

Since the OraQuick test is waived under CLIA, there are no specific Federal 

requirements on who can perform the test. Each site should find out if there are 

State or other requirements for personnel that they must meet. Beyond any 

regulatory requirements, it is recommended that certain qualities be considered 

when selecting personnel to perform the OraQuick test. The following list of 

qualities resulted from practical considerations and expert opinion: 

 Sincerity and commitment – A dedication to performing testing according to 

defined procedures. 









Literacy – The ability to read instructions and record results is critical. 

Organizational skills – The need for this quality will depend on the number 

and complexity of tasks an individual performs in the testing process. If test 

volume is high and the individual performing testing is doing several tests or 

managing several other tasks simultaneously, organizational skills can be 

critical. 

Decision-making skills – Testing personnel should be able to interpret results 

and be able to recognize and handle problems that might come up. 

Communication skills – If the person performing the test also is the one who 

shares results or other information with the person being tested, being able to 

communicate clearly is important. 

Components of 

training

Training is crucial to ensuring quality testing.3

 Training is also required to be able 

to purchase the OraQuick test kit (see Appendix A for details on the FDA sales 

restrictions). Staff should be fully trained on how to perform their assigned tasks 

and responsibilities. Training should be documented for each staff member; using 

training checklists is one way to handle this documentation (see Appendix B for 

an example of a training checklist). The key components to include in a training 

program are 

 How to perform the test, including procedures performed before, during 

and after testing. 

 How testing is integrated into the overall counseling and testing program. 

 The importance of QA and the elements of the site’s QA program. 

 The use and importance of Universal (or Standard) Precautions/biohazard 

safety. 
QA Guidelines for OraQuick 7 

Testing Personnel (continued) 

Training method Experience with training to perform the OraQuick test (CDC unpublished data) 

shows that a training method should optimally include the following activities: 

 Read the instructions for performing the test. 

 Watch someone perform the test or view a video of someone performing 

the test. 

 Practice performing the test with positive and negative control materials. 

 Practice performing the finger-stick collection procedure. 

 Review the procedures and forms on how to document testing. 

Competency 

assessment

Before a trainee is permitted to perform testing alone for the first time, his or her 

ability to conduct the test should be demonstrated and documented. This 

assessment should also be carried out at periodic intervals after training, such as 

every six months or other interval as determined by the testing site. This 

assessment can be carried out in many ways, but regardless of the method, every 

task for which a staff member is responsible should be evaluated. A supervisor or 

trainer should perform the assessment, using a combination of methods to 

determine competency. Examples of these methods are presented below. 

Assessing 

performance of 

tasks done before 

testing 

To assess the task performance before testing, staff should be observed as they: 

 Check and record the temperatures of the testing and storage areas. 

 Set up the testing area, label the device and prepare control and test results log 

sheets. 

 Run the external controls and record results. 

Assessing 

performance of 

tasks done during 

testing

To assess staff’s ability to perform the test and interpret results 

 Observe the staff member performing the finger-stick, collecting the blood on 

a test loop and placing it into the testing vial. 

 Observe how the test is performed on a client/patient. If such observation will 

interfere with actual client-provider interactions, observe test performance on 

a volunteer. 

 Evaluate the use of Universal or Standard Precautions and procedures for 

biohazard and sharps (e.g., lancets, needles) waste disposal. 

 Review results obtained on a panel of referenced specimens that show a range 

of results, such as five specimens that include non-reactive, weakly reactive 

and reactive results. Control materials supplied by the manufacturer may be 

used as a source of specimens in the panel. In addition, specimens may be 

obtained from laboratories performing confirmatory testing or from other 

commercial sources. 

 Appraise the individual’s ability to interpret results. This might include using 

previously used test devices or pictures of devices that show non-reactive, 

weakly reactive, reactive and invalid results. 
QA Guidelines for OraQuick 8 

Testing Personnel (continued) 

Assessing 

performance of 

tasks done after 

testing

To assess task performance after testing: 

 Review test records and quality control results documentation. 

 Observe oral reporting of results to a test subject (if trainee’s responsibility). 

 Observe venous blood and/or oral fluid specimen collection and handling for 

confirmatory testing. If the frequency of OraQuick reactive results is low, the 

trainee should be observed collecting blood and/or oral fluid from a staff 

volunteer and demonstrate how it is processed for confirmatory testing. 

 Verify that confidentiality is maintained. 
QA Guidelines for OraQuick 9 

Process Control 

What is process 

control? 

Process control refers to the activities and techniques that are carried out to ensure 

that the testing procedures are performed correctly, the environment is suitable, 

and the test kit works as expected to produce accurate and reliable results. 

Steps in the testing 

process 

Steps in the testing process follow the path of workflow beginning with tasks 

before testing, followed by those conducted during and after testing. This path of 

workflow and the associated steps are shown in the table below. Detailed 

descriptions about each of the steps listed in this table are provided in the 

remainder of this document. 

Before testing During testing After testing 

































Check storage and room 

temperatures daily 

Check inventory and test kit lots, 

as needed 

Receive request for testing 

Provide HIV/AIDS information 

to the test subject 

Set up test area, label test device 

Perform external quality control 

according to the manufacturer’s 

and the site’s instructions 

Follow biohazard safety 

precautions 

Collect the finger-stick 

specimen 

Perform the test 

Interpret test results 

Clean up and dispose of 

biohazardous waste 

Report results to client 

Document results 

Collect, process and transport 

confirmatory test specimens 

Manage confirmatory test 

results 

Participate in external quality 

assessment (periodically) 

Before Testing 

Overview As shown in the table above, there are a number of steps that must be followed 

before testing the blood sample for HIV. These activities are in place to ensure 

that the conditions in which the tests are stored and performed are suitable, the 

test area and the test subject are prepared, and the test is working appropriately. 

Steps in the testing process 
QA Guidelines for OraQuick 10 

Before Testing (continued) 

Temperature 

control: test kits 

and control kits

Test kits and controls must be stored in an environment within the temperature 

ranges specified by the manufacturer. Store test kits at 2o

 to 27o C (35o to 80o F). 

If test kits are refrigerated, the pouch containing the test device and developer 

solution must be brought to room temperature (15o

 to 27o C or 59o to 80o F) before 

opening. Control kits must be refrigerated at 2o

 to 8o C (35o to 46o F). To ensure 

these temperature ranges are maintained, monitor and document temperatures of 

the storage areas each day testing is performed. If the temperature falls outside of 

the specified range, take action as needed to adjust the temperature. To monitor 

the temperatures, place thermometers in the storage areas (e.g., in the refrigerator 

and on the shelf in the room where kits are stored). Check and record 

temperatures on a log sheet each day testing is performed. An example 

temperature log is provided in Appendix C. 

Temperature 

control: testing 

area 

The temperature in the area where the test will be performed must be within the 

range of 15o

 to 27o C (59o to 80o F). If the test must be performed at a temperature 

below 15o

C/59oF or above 27oC/80oF, run external controls that have been stored 

within the proper temperature range to find out if the test can be performed at 

another temperature (see the section below on external controls). If testing is 

carried out in the field, monitor the temperature of the test and control kits in their 

portable storage containers and check the temperature where testing will be 

performed if it appears to be outside the specified range. If there are doubts about 

the testing area temperature or whether test kits have stayed within the appropriate 

temperature range, run a positive and negative external control as described in the 

quality control section below. 

Checking inventory 

and test kits

Procedures should be in place to ensure that an adequate supply of unexpired test 

kits, controls, and supplies is available. Test kits and controls have a defined shelf 

life. Use the oldest first. Never use test or control kits beyond their expiration 

dates. It is helpful to use a log sheet to document when test and control kits are 

received, their lot numbers and expiration dates. Also, once control vials are 

opened, they are stable for 21 days. Therefore, record on the vial the date it is 

opened and discard unused opened controls after 21 days. As described in the 

package insert and in the section on quality control below, run the positive and 

negative controls with new lots and new shipments of test kits before using them 

for testing, to verify that they work as expected. 
QA Guidelines for OraQuick 11 

Before Testing (continued) 

Setting up the 

testing area and 

labeling the test 

device

Before testing, the testing area should be prepared according to the specific site 

procedure, which should include directions for setting up the workspace listed in 

the test kit instructions, as well as instructions for how to label testing devices and 

complete report forms, including the method for identifying each person to be 

tested to ensure specimens are not mixed up during the testing process. Labeling 

is especially important when more than one test is being performed at the same 

time. Label components of the test with the name or identifying number of the 

person being tested before collecting the specimen. These components include 

the developer solution vial, test device, and documents for recording results. 

Using preprinted labels improves the efficiency of performing this task. 

Note: Do not place a label over the two holes on the back of the test device as this 

can cause an invalid result. 

Providing 

information to test 

subjects

OraSure Technologies, Inc., provides a “Subject Information” pamphlet that must 

be given to each person getting tested prior to performing the HIV rapid test. 

Each site may provide additional information. For further details, see the CDC 

website http://www.cdc.gov/hiv/pubs/rt-counseling.htm, the Revised Guidelines 

for HIV Counseling, Testing, and Referral, MMWR Recommendations and 

Reports, RR-19, vol. 50, November 9, 20014

 and applicable State or local rules. 

Quality control There are two types of quality control (QC) for the OraQuick test. These are 

described in the table below. 

Type of quality control Description of activity 

Internal controls A control is built in to each testing device to verify 

that the specimen was adequate and the solution 

flowed through the device as intended. 

External controls Known reactive and non-reactive specimens 

(controls) are available from the manufacturer to 

sites purchasing the OraSure Rapid HIV Test. They 

are used to evaluate the accuracy of the test in 

detecting antibody to HIV and to check if the person 

conducting the test performs it correctly. 

External quality 

control 

To verify that the test device is accurately detecting HIV-1 antibodies, external 

positive and negative controls must be tested from time to time. The test kit 

manufacturer provides external controls in the form of the OraQuick Rapid HIV-1 

Antibody Test Kit Controls. This control kit must be ordered separately from the 

test kit. It includes one vial each of an HIV antibody-negative (non-reactive) and 

positive (reactive) human plasma control. How often controls are run to verify the 

accuracy of the test will depend on the number of tests carried out by the site, how 

often new test kit shipments or lot numbers are received by a site, changes in how 

the tests are stored and testing area temperatures, and how often staff who conduct 

the testing change. An example of a log for control testing results is available in 

Appendix D. 
QA Guidelines for OraQuick 12 













Before Testing (continued) 

Run external 

controls according 

to the 

manufacturer’s 

instructions 

The manufacturer has set guidelines for the minimum number of times to run 

the negative and positive controls. This is described in the test kit instructions, 

which specifies running controls under the following circumstances: 

By each new operator prior to performing testing on patients, 

When opening a new test kit lot (a test kit lot is defined as the boxes of test 

devices that contain either 25 or 100 tests that have the same lot number 

labeled on the outside of the boxes), 

Whenever a new shipment of test kits is received (even if it is the same kit 

lot number in current use), 

If the temperature of the test storage area falls outside of 2o

-27o C (35o-

80o

F), 

If the temperature of the testing area falls outside of 15o

-27oC (59o-80oF), 

and 

At periodic intervals as dictated by the user facility. 

Frequency of 

running external 

controls on the basis 

of test volume 

In addition to the specific circumstances listed in the manufacturer’s 

instructions, testing sites should determine the optimal frequency for running 

controls on the basis of their test volume. When external controls provide 

incorrect results, none of the tests that were run since the last time control 

results were correct can be considered valid. This means that everyone who was 

tested since the last time controls ran correctly will need to be called back and 

retested (unless a confirmatory test was ordered). Sites testing large numbers of 

persons, and especially those that offer anonymous testing, should plan to run 

controls more often than facilities that conduct fewer tests. Each site needs to 

decide how often to run controls based on its own situation and testing 

practices. Instructions for some other waived tests recommend running external 

controls each time a new box of 25 tests is opened. Facilities that test 25 or 

more subjects a day should run controls every day. Low volume sites, such as 

those testing fewer than 25 subjects per month, should run external controls 

every two to four weeks at a minimum. Controls should be run more often if 

new lots or shipments are opened or if storage or testing temperatures fluctuate.

During Testing 

Overview This phase of the testing process involves running the test and interpreting the 

results. Activities during testing include collecting the specimen, performing the 

test, interpreting the internal control and client/patient test results, and following 

biohazard safety guidelines. 

Collecting the 

OraQuick 

specimen 

Follow the written procedure for finger-stick specimen collection. Further 

information on collecting blood by skin puncture can be found in Procedures and 

Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture.5
QA Guidelines for OraQuick 13 







During Testing (continued) 

Performing the test 

and interpreting 

results 

Follow the manufacturer’s instructions for performing the test and interpreting the 

results. Results can be one of the following: 

Nonreactive (negative) 

Reactive (preliminary positive) 

Invalid (the test result is inconclusive and cannot be interpreted; see below for 

information on handling invalid results) 

Evaluating internal 

control results

Each OraQuick device includes a built-in (internal) control. When an appropriate 

line develops at the center of the “C” location on the device, the patient’s 

specimen has been correctly loaded and traveled through the test strip, indicating 

a valid test. Additional information is provided in the test kit package insert. 

These controls are included in every device, and control results are evaluated with 

every test. If the internal control does not produce the expected result, the test 

result for the patient is not valid, cannot be reported, and the test must be repeated. 

If a second invalid result occurs, external controls should be evaluated as 

described below before repeating the test a third time. 

Running external 

controls to 

troubleshoot 

invalid results

CDC experience (unpublished data) has shown that external controls should be 

run to help find out if repeated invalid test results are due to the test device, test 

performance, or the patient specimen. If the same test kit lot yields repeated 

invalid results, the test kit may have gone bad. It is important to run the positive 

and negative controls whenever two consecutive invalid test results are obtained 

on a person being tested. 

Biohazard 

safety/Universal 

(Standard) 

Precautions 

All specimens and materials contacting specimens must be handled as if they are 

capable of transmitting an infectious organism. As described in Appendix A, each 

site must ensure that the Occupational Safety and Health Administration (OSHA) 

bloodborne pathogens standards are met, that is persons doing the testing must 

know how to safely handle potentially infectious specimens. Also, according to 

Universal (Standard) Precautions, all human blood should be treated as if known 

to be infectious for HIV, hepatitis B virus, and other bloodborne pathogens. Sites 

must have available and follow procedures for biohazard safety to include 

instructions for the use of gloves, hand washing, sharps and biohazardous waste 

disposal, spill containment and disinfection. A different pair of gloves should be 

worn for collecting a specimen from each person being tested. Used gloves 

should be handled as biohazardous waste. For further details on these precautions 

see the OraQuick package insert, OSHA regulations and guidelines on Universal 

and Standard Precautions. 1, 6, 7, 8
QA Guidelines for OraQuick 14 









After Testing 

Overview Quality assurance extends to those activities completed following the performance 

of the test. Each site should have established procedures for: 

Reporting and recording results, 

Referring specimens (or test subjects, if specimens are not collected on-site) 

for confirmatory testing, 

Managing confirmatory test results, and 

Conducting external quality assessment. 

Reporting results Reporting procedures should describe how results are provided to the person 

being tested (verbal and/or written results) and how results are documented in the 

person’s chart and in the test result logs. Some States have laws and regulations 

that include certain reporting criteria for HIV testing results. Check with your 

State agency for more information on these requirements. See Appendix A for 

State agency contact information and Appendix E for an example of a test result 

log. 

Referral for 

confirmatory 

testing

Whenever the OraQuick test result is reactive (preliminary positive), a 

confirmatory test must be performed to confirm that the person being tested is 

infected with HIV. Therefore, each site must have established procedures for 

referral of either test specimens or persons being tested for confirmatory testing 

when OraQuick results are reactive. If specimens are collected on-site, the site 

must establish procedures describing how to collect, label, process, store and 

document specimen transfer; transport the confirmatory test specimens to the 

site(s) where they will be tested; and obtain the confirmatory results to give to the 

client/patients. It should be indicated on the specimen transfer sheet that the 

specimen is from an individual who had a reactive OraQuick rapid test result. See 

the Appendix F for an example of a specimen transfer sheet. Collecting 

confirmatory specimens on-site may improve follow-up, since some clients may 

not go elsewhere for the testing or to obtain results. However, if the site is not 

able to collect confirmatory test specimens, a procedure must be in place for 

referring persons to another site to obtain this testing. 
QA Guidelines for OraQuick 15 







After Testing (continued)

Confirmatory 

testing protocols For confirmatory testing, the current standard testing algorithm should be 

followed, with the following exceptions: 

All OraQuick reactive (preliminary positive) results must be followed up with 

either a Western blot or immunofluorescent assay (IFA) for confirmation. 

Confirmatory testing can be done on blood (plasma, serum or dried blood 

spots) or oral fluid specimens. Urine testing should not be performed due to 

its lower sensitivity (i.e., ability to detect positive results). 

With blood specimens, enzyme immunoassay (EIA) screening tests prior to 

the Western blot or IFA confirmatory test are optional. If an EIA is 

performed, even if it is non-reactive, the specimen must proceed to Western 

blot or IFA testing (reactive EIA specimens will automatically be tested by 

Western blot or IFA). For oral fluid testing, both EIA and Western blot 

testing should be performed to confirm results. 

Follow up testing 

for negative 

confirmatory result 

Most confirmatory test results will be positive; however, some may be negative or 

indeterminate. If the confirmatory test result is negative, specimen mix-up needs 

to be ruled out versus a false positive OraQuick result. If the Western blot or IFA 

test is negative, it is recommended that:





For blood specimens, a confirmatory test should be repeated with a new 

specimen to rule out specimen mix-up.

For oral fluid specimens, a repeat confirmatory test with a blood specimen 

should be done, since the oral fluid test is less sensitive than the blood test.

Follow up testing 

for indeterminate 

results 

Occasionally, confirmatory test results are indeterminate. If the Western blot or 

IFA is indeterminate, it is recommended that:





For blood specimens, the person should be advised to return for repeat testing 

in one month. See CDC’s Revised Guidelines for HIV Counseling, Testing 

and Referral found at 

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5019a1.htm.

For oral fluid specimens, the Western blot or IFA test should be repeated 

using a blood specimen.

Managing 

confirmatory 

results 

OraQuick testing sites that refer specimens for confirmatory testing should have 

established procedures describing how to: 







Match the client’s/patient’s confirmatory test results with their OraQuick 

results to find potential discrepancies and to ensure that testing was performed 

according to the protocol described above, 

Report the test result to the person being tested, and 

Obtain any additional specimens needed to resolve potential specimen mix-up 

and for retesting, as needed. 
QA Guidelines for OraQuick 16 

After Testing (continued) 

Handling result 

discrepancies 

Procedures should describe how to handle result discrepancies when the OraQuick 

result was reactive and the confirmatory test negative or indeterminate. If the 

laboratory providing confirmatory testing performed an EIA test only and 

reported a non-reactive or negative result, the OraQuick testing site should contact 

the confirmatory testing laboratory and request a Western blot test or IFA test. If 

the original specimen is not available, a new specimen will need to be collected 

from the person in question to be used for confirmatory testing. 

External 

assessment

External assessment, or an evaluation of the testing process by a source outside 

the testing site, can look at how testing is being performed and whether it is being 

performed reliably. It can also help to identify existing or potential problems. 

Moreover, information gathered can provide an educational tool to improve 

performance. Some form of external assessment is highly recommended, but it is 

not required by Federal (CLIA) regulations since the test is waived and the test kit 

manufacturer does not specifically require it. 

Methods for 

external assessment 

Every reactive OraQuick test is externally assessed by a second, confirmatory test. 

However, if there is a low prevalence of HIV infection in the population being 

testied, these assessments may be rare and will not provide an external check for 

the majority of the results, i.e., those that are nonreactive. Other ways to assess 

performance may be needed. Some external assessment mechanisms include: 







Comparing the OraQuick reactive results with the confirmatory test results. 

Arranging for someone outside the organization to observe testing. 

Participating in a proficiency testing or external evaluation program (for more 

information on these programs, see Appendix G). 
QA Guidelines for OraQuick 17 











Documents and Records 

Overview One of the hallmarks of a QA program is comprehensive documentation. Sites 

using the OraQuick test should have policies and procedures describing what QA 

records are required and how and when they are reviewed, stored and destroyed. 

Having a supervisor review records periodically is recommended. State 

regulations or other governmental or accrediting agencies may require facilities to 

have specific record retention policies. QA records include the following: 

Training documentation (Appendix B) 

Temperature logs (Appendix C) 

External control result logs (Appendix D) 

Test result logs (Appendix E) 

Specimen transfer logs (Appendix F) 

Temperature logs Temperature logs should include a daily record of the refrigerator temperature in 

which controls are stored, the temperature where test kits are stored and the 

temperature of the testing area. Thermometers should be placed in each location. 

Laboratory grade thermometers (can be purchased from medical or laboratory 

supply houses) are recommended and their accuracy checked periodically (e.g., 

every six months) by comparison with another thermometer. 

External control 

result logs 

External control records should include the date and time of control testing, lot 

number and expiration of the test kit, lot number and expiration date of the 

controls, control results, and corrective action taken if control results are 

unacceptable. Control records should be kept in the order in which they were 

completed so they can be easily compared with the test records. This will help 

find answers if there are questions about testing performed within a specific time 

frame. 

Test result logs Test result records should include the date and time of testing, an identifier for the 

person being tested, a test kit lot number and expiration date, test result, action 

taken if the result was invalid, identification of the person who performed the test, 

whether confirmatory testing was requested, including the type of specimen sent 

for confirmation (e.g., oral fluid, blood), and the confirmatory test results when 

they are available. If more than one person is conducting testing, there should be 

a mechanism to chronologically link the test record log sheets to detect problems, 

such as invalid results occurring repeatedly with the same kit lot number. 
QA Guidelines for OraQuick 18 

Troubleshooting 

Overview Each site should have a method to detect and resolve problems that occur at any 

point in the testing process, especially those that may affect the accuracy of test 

results. Significant problems should be immediately reported to the appropriate 

supervisory personnel. 

Procedures Procedures should be available to all testing personnel for the following: 









When to discontinue testing, e.g., when the external control results are 

unacceptable as described in the package insert. 

How to take corrective action, or an action taken in response to a problem, 

such as contacting the manufacturer when the external control results are 

unacceptable and following the advice provided. 

How to document problems and actions taken, such as a logbook where 

problems and corrective actions taken can be recorded. 

How to verify the corrective actions taken addressed the problem. 
QA Guidelines for OraQuick 19 

References 

1. OraQuick Rapid HIV-1 Antibody Test package insert. OraSure Technologies, Inc., Bethlehem, PA 

18015, 2003. 

2. NCCLS document HS1-A. A quality system model for health care, Approved guideline. NCCLS, 

Wayne, PA, 2002. 

3. NCCLS document GP21-A.Training verification for laboratory personnel, Approved guideline. 

NCCLS, Wayne, PA, 1995.

4. CDC. CDC revised guidelines for HIV counseling, testing, and referral. MMWR Recommendations 

and Reports. 2001;RR-19:50. 

5. NCCLS document H4-A4. Procedures and devices for the collection of diagnostic blood specimens 

by skin puncture, Approved guideline. NCCLS, Wayne, PA, 1999. 

6. Occupational Safety and Health Administration regulations, 29CFR Part 1910. Available from 

http://www.osha.gov/SLTC/bloodbornepathogens/index.html

7. CDC. Perspectives in disease prevention and health promotion update: Universal precautions for 

prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne 

pathogens in health-care settings. MMWR 1988; 37(24):377-88. 

8. Garner JS, Hospital Infection Control Practices Advisory Committee. Guideline for isolation 

precautions in hospitals. Infect Control Hosp Epidemiology 1996;17:53-80, and Am J Infect Control 

1996;24:24-52.