ABSTRACT
Diagnostic tests for detecting emerging influenza virus strains with pandemic potential are critical for directing global influenza prevention and control activities. In 2008, the Centers for Disease Control and Prevention received US Food and Drug Administration approval for a highly sensitive influenza polymerase chain reaction (PCR) assay. Devices were deployed to public health laboratories in the United States and globally. Within 2 weeks of the first recognition of 2009 pandemic influenza H1N1, the Centers for Disease Control and Prevention developed and began distributing a new approved pandemic influenza H1N1 PCR assay, which used the previously deployed device platform to meet a >8-fold increase in specimen submissions. Rapid antigen tests were widely used by clinicians at the point of care; however, test sensitivity was low (40%-69%). Many clinical laboratories developed their own pandemic influenza H1N1 PCR assays to meet clinician demand. Future planning efforts should identify ways to improve availability of reliable testing to manage patient care and approaches for optimal use of molecular testing for detecting and controlling emerging influenza virus strains.
Subject(s)
Communicable Disease Control/methods , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/diagnosis , Influenza, Human/epidemiology , Pandemics/prevention & control , Polymerase Chain Reaction/methods , Virology/methods , Centers for Disease Control and Prevention, U.S. , Clinical Laboratory Techniques/methods , Humans , Influenza, Human/prevention & control , Influenza, Human/virology , United States/epidemiologyABSTRACT
BACKGROUND: Since 1989, the CDC's Model Performance Evaluation Program has shipped samples to voluntary participant laboratories that test for HTLV antibodies. Each laboratory tests the well-characterized samples, reports the results, and provides information about its testing practices. The data from 15 performance survey periods are reported here. STUDY DESIGN AND METHODS: Multiple logistic regression was used to analyze all data from 15 survey periods from 1989 through 1996. RESULTS: The mean analytic sensitivity for EIA was 99.2 percent per survey period (range, 96-100%), the mean analytic specificity was 97.8 percent (75.6-100%), and the overall accuracy was 88.8 percent (63.8-100%). The mean analytic sensitivity for Western blot was 88.8 percent (75.6-100%); the mean analytic specificity was 95.7 percent (86.7-100%), and the overall accuracy was 91.1 percent (78.1-100%). CONCLUSIONS: Statistical analyses suggested associations between performance and both the retroviral serologic status of the sample and the analytical testing method. Western blot accuracy was associated with weekly testing volume. In early survey periods, performance problems were noted in the analysis of samples from donors with concomitant HTLV and HIV infections and those from donors who were positive for HTLV-II. Technological developments in test methods, such as the addition of recombinant antigens, appeared to have improved the laboratory performance of specific testing methods.
Subject(s)
Deltaretrovirus Antibodies/blood , Blotting, Western , Clinical Laboratory Techniques/standards , Evaluation Studies as Topic , Humans , Immunoenzyme Techniques , Logistic Models , Sensitivity and SpecificityABSTRACT
CONTEXT: Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to promote uniform quality and standards among all testing sites in the United States. The performance indicators specified in the legislation are proficiency testing (PT) performance and periodic inspections. OBJECTIVE: To evaluate variation in PT performance by type of testing facility during the first year of compulsory participation under CLIA. DESIGN: All 1994 PT score data electronically reported to the Health Care Financing Administration as a component of compliance with the CLIA regulations were obtained. Over 1.2 million PT event scores from 17058 unique testing sites were sorted into 2 groups based on the type of testing facility: hospitals and independent laboratories (HI) and all other testing sites (AOT). MAIN OUTCOME MEASURES: Satisfactory and unsatisfactory performance rates for HI and AOT for each analyte and/or test, according to the criteria specified by the CLIA regulations. RESULTS: The aggregate rates of satisfactory event performance for all regulated analytes, tests, and specialties were 97% and 91% for the HI and AOTgroups, respectively. The aggregate odds ratio for unsatisfactory PT event performance for the AOT group compared with the HI group was 2.89, with a range of 2.19 to 7.51 for the individual analytes. CONCLUSION: There was a consistent difference in PT performance during the first full year of compulsory PT under the CLIA regulations based on the type of testing facility performing the analysis. Traditional testing sites achieved higher rates of satisfactory performance than newly regulated, alternative testing sites.
