1. Abstract Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey Department of Health and Senior Services - Division of HIV/AIDS Services, NJHIV operates one of the largest, centralized rapid HIV test programs in the country. Integral to the program is a comprehensive quality assurance program. Of paramount importance to the program is the accuracy of the each site’s data. Due to reports of increased false-positive test results in San Francisco and New York, we assessed the accuracy of NJHIV testing data in order to reliably review OraQuick performance in New Jersey. Objective: Implementation of a self-evaluation methodology able to validate data and to verify that OraQuick testing is performs within specifications in New Jersey. Methods: NJHIV sites maintain logs of each test performed, with monthly reviews by RWJMS. Data is consolidated via Excel spreadsheets and passed into a rapid HIV database. Scheduled and unscheduled audits of client records are coupled with re-education of staff at client sites, as needed. Audit results were compared with the NJHIV database and two State databases, and corrected by referring back to client files. Data was examined by month, site, reagent lot, sample type and test result. Results: Data from 22 of 23 sites was complete in the NJHIV database. For one site, comparable defects were found in all databases. After remediation of recordkeeping, data from that site is now also complete. The analysis showed specificity in the NJHIV program of 99.6%--within the manufacturer’s specifications. The increased false- positive results that was reported in other jurisdictions has not occurred within the quality assurance framework of the NJHIV program. Conclusion: Data monitoring at the NJHIV program allows for detailed examination of patterns of test results. Practices at the NJ HIV Rapid Testing Program are generating accurate results which fall within acceptable specificity limits. Results FALSE POSITIVE RATES IN NEW JERSEY Fifteen sites have been identified as high volume and prevalence sites. Fourteen more have been identified as second tier in importance based on prevalence and volume. The remaining 129 satellite sites are of lower priority based on prevalence and testing volume and will be implemented as resources permit. RETURN FOR RESULTS: Through July 2004, 3062 people had HIV rapid testing, 3053 of whom (99.7%) received their results and had posttest counseling. Out of the 110 confirmed positive results, 69 (63%) were previously undiagnosed patients. QUALITY CONTROL (QC) RESULTS: Sites run QC for a variety of reasons. During 2003-4, 19.5% (1925) of devices were used to perform QC. The majority of QC was run as a part of mandated operating procedures. Approximately 6% of QC was run because of ‘ Out of Temperature Range ’ findings at monitored storage locations. Mandatory QC due to an invalid result was extremely rare. FALSE POSITIVE RATE: The false positive rate was 4.05/10,000. All false positive were Type I discordants i.e., reproducible, OraQuick ® Positive, EIA/Western Blot negative. No examples of Type II discordants – evolving infections in a window period. Conclusion In New Jersey, the ability to start rapid-testing is limited by licensure process and quality assurance requirements By use of a standardized, centralized approach rapid testing has been implemented in an efficient, cost-effective and quality-focused process Low false-positive rates in New Jersey may be due to currently employed methodology and aggressive quality assurance oversight ANALYSIS OF FALSE POSITIVE RAPID HIV TESTS Jake Nelson 1, Evan M Cadoff 1, MD, Sindy M Paul, MD, MPH 2, Eugene G Martin, PhD 1, Vivian Shih 1, Gratian Salaru, MD 1 UMDNJ – Robert Wood Johnson Medical School 1 and New Jersey Department of Health and Human Services 2 Background Built upon existing UMDNJ-Robert Wood Johnson Medical School, multi-facility, point-of-care-testing program Centralized quality assurance process using pathologists, technologists and informaticians A single site in New Brunswick, NJ was used to delineate process develop strategy, validate forms, communications, equipment and techniques. Testing began November 2003 at the first NJ licensed site – a primary site in close proximity to the medical school. Currently there are 117 sites including fixed and mobile venues Testing activities are reviewed monthly by a medical technologist Quality Assurance Plan Management by a board certified Pathologist Supervisory control through site coordinators Central lab overseesr: Regulatory and proficiency testing Acquisition and validation of supplies Inventory control Common procedures and core policies Uniform administration at all locations Common training, certification of personnel, forms Core communication hub www.njhiv.org www.njhiv.org Quality Control Rules Standardized monthly site visits – ‘ The Report Card ’ Intra and inter site comparisons to insure that requirements for quality and process control are maintained Quality Assurance Issues Encountered: Temperature Issues Reagent Storage Storage of Controls Testing Environment Reading of Devices Under vs. Over Ascertainment Documentation Availability of procedures Supervisory Oversight Availability of Technical Support AIDS Coalition of Southern New Jersey Atlantic City Health Department Bergen County Health Department Burlington County Health Department Camden AHEC Camden County Health Department East Orange Health Department Eric B. Chandler Health Center FamCare Henry J. Austin Health Center Horizon Health Center Hunterdon County Health Department Hyacinth Foundation Martin Luther King Outreach Morristown Memorial Hospital Newark Community Health Center NJCRI Ocean County Health Department Paterson Health Department Plainfield Community Health Center Proceed Robert Wood Johnson Medical School Trinitas Hospital UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES Primary Satellite fixed mobile Pale colors indicate pending sites

2. ABSTRACT Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey Department of Health and Senior Services - Division of HIV/AIDS Services, NJHIV operates one of the largest, centralized rapid HIV test programs in the country. Integral to the program is a comprehensive quality assurance program. Of paramount importance to the program is the accuracy of the each site’s data. Due to reports of increased false-positive test results in San Francisco and New York, we assessed the accuracy of NJHIV testing data in order to reliably review OraQuick performance in New Jersey. Objective: Implementation of a self-evaluation methodology able to validate data and to verify that OraQuick testing is performs within specifications in New Jersey. Methods: NJHIV sites maintain logs of each test performed, with monthly reviews by RWJMS. Data is consolidated via Excel spreadsheets and passed into a rapid HIV database. Scheduled and unscheduled audits of client records are coupled with re-education of staff at client sites, as needed. Audit results were compared with the NJHIV database and two State databases, and corrected by referring back to client files. Data was examined by month, site, reagent lot, sample type and test result. Results: Data from 22 of 23 sites was complete in the NJHIV database. For one site, comparable defects were found in all databases. After remediation of recordkeeping, data from that site is now also complete. The analysis showed specificity in the NJHIV program of 99.6%--within the manufacturer’s specifications. The increased false-positive results that was reported in other jurisdictions has not occurred within the quality assurance framework of the NJHIV program. Conclusion: Data monitoring at the NJHIV program allows for detailed examination of patterns of test results. Practices at the NJ HIV Rapid Testing Program are generating accurate results which fall within acceptable specificity limits. AIDS Coalition of Southern New Jersey Atlantic City Health Department Bergen County Health Department Burlington County Health Department Camden AHEC Camden County Health Department East Orange Health Department Eric B. Chandler Health Center FamCare Henry J. Austin Health Center Horizon Health Center Hunterdon County Health Department Hyacinth Foundation Martin Luther King Outreach Morristown Memorial Hospital Newark Community Health Center NJCRI Ocean County Health Department Paterson Health Department Plainfield Community Health Center Proceed Robert Wood Johnson Medical School Trinitas Hospital 4/29/2015 UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES Primary Satellite fixed mobile Pale colors indicate pending sites S.F. Clinics getting high false-positive rate on oral hiv test Sabin Russell San Francisco Chronicle Friday, December 9, 2005 “A promising new oral hiv test being considered for home use has produced at least 47 false positives at san Francisco public health clinics, throwing a scare into those who received the results and raising questions about the test's suitability for widespread use in the united states and abroad. The oraquick advance hiv test approved for professional use by the food and drug administration in March 2004 detects in just 20 minutes antibodies to the virus that causes aids, using fluid swabbed from the m Mouth. Its speed and ease of use make the test a particularly suitable candidate for hiv prevention and treatment Efforts that stress frequent testing and speedy access to care for those who test positive. San francisco department of public health officials were alarmed last week when their analyses of more Than 6,000 oral tests since spring turned up 47 instances in which the results were positive, but follow-up tests Showed those patients were not infected.”

3. Quality Assurance Plan Management by a board certified Pathologist Supervisory control through site coordinators Central lab overseesr: Regulatory and proficiency testing Acquisition and validation of supplies Inventory control Common procedures and core policies Uniform administration at all locations Common training, certification of personnel, forms Core communication hub www.njhiv.org www.njhiv.org Quality Control Rules Standardized monthly site visits – ‘ The Report Card ’ Intra and inter site comparisons to insure that requirements for quality and process control are maintained Quality Assurance Issues Encountered: Temperature Issues Reagent Storage Storage of Controls Testing Environment Reading of Devices Under vs. Over Ascertainment Documentation Availability of procedures Supervisory Oversight Availability of Technical Support