Last data update: Oct 28, 2024. (Total: 48004 publications since 2009)
Records 1-4 (of 4 Records) |
Query Trace: Candal F[original query] |
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Lessons from the reestablishment of Public Health Laboratory activities in Puerto Rico after Hurricane Maria
Hardy MC , Stinnett RC , Kines KJ , Rivera-Nazario DM , Lowe DE , Mercante AM , Gonzalez Jimenez N , Cuevas Ruiz RI , Rivera Arbolay HI , Gonzalez Pena RL , Toro M , Trujillo AA , Pappas CL , Llewellyn AC , Candal F , Burgos Garay M , Gomez GA , Concepcion Acevedo J , Ansbro M , Moura H , Shaw MW , Muehlenbachs A , Romanoff LC , Sunshine BJ , Rose DA , Patel A , Shapiro CN , Luna-Pinto SC , Pillai SK , O'Neill E . Nat Commun 2019 10 (1) 2720 Public Health Laboratories (PHLs) in Puerto Rico did not escape the devastation caused by Hurricane Maria. We implemented a quality management system (QMS) approach to systematically reestablish laboratory testing, after evaluating structural and functional damage. PHLs were inoperable immediately after the storm. Our QMS-based approach began in October 2017, ended in May 2018, and resulted in the reestablishment of 92% of baseline laboratory testing capacity. Here, we share lessons learned from the historic recovery of the largest United States' jurisdiction to lose its PHL capacity, and provide broadly applicable tools for other jurisdictions to enhance preparedness for public health emergencies. |
Comparative evaluation of Aptima HIV-1 Qualitative RNA assay performance using plasma and serum specimens from persons with established HIV-1 infection.
Ethridge SF , Wesolowski LG , Nasrullah M , Kennedy MS , Delaney KP , Candal D , Owen M . J Clin Virol 2011 52 Suppl 1 S63-6 BACKGROUND: Blood specimens for HIV testing are frequently collected using serum collection tubes. The Aptima HIV-1 RNA Qualitative test, originally approved for diagnostic use as a supplemental test for use with plasma, is now approved for use with serum, and may be used in new laboratory-based HIV testing algorithms which detect acute and established HIV infections. OBJECTIVES: To compare the sensitivity of Aptima using serum and plasma specimens from persons with established HIV infection. STUDY DESIGN: Parallel serum and plasma specimens were collected from 325 persons with established HIV-1 infection who had positive immunoassay (IA) and Western blot (WB) results. Samples with negative Aptima results were considered false-negative and were subjected to repeat testing. Aptima sensitivity for serum and plasma was calculated relative to IA and WB, and compared using the McNemar test. RESULTS: The sensitivity of Aptima using serum (97.23%, 95% confidence interval [CI] 94.81-98.73) was similar to that using plasma (97.54%, 95% [CI] 95.21-98.93) p=1.00. Five of ten specimens initially false-negative on either serum or plasma were reactive on repeat testing. No specimens initially classified as false-negative on both matrices were reactive on both matrices on repeat testing. CONCLUSIONS: In specimens from persons with established infections, Aptima performed with similar sensitivity when used with serum or plasma. Using serum for immunoassay screening and supplemental testing may provide added convenience for laboratories. |
Performance of an alternative laboratory-based algorithm for diagnosis of HIV infection utilizing a third generation immunoassay, a rapid HIV-1/HIV-2 differentiation test and a DNA or RNA-based nucleic acid amplification test in persons with established HIV-1 infection and blood donors.
Wesolowski LG , Delaney KP , Hart C , Dawson C , Michele Owen S , Candal D , Meyer WA 3rd , Ethridge SF , Branson BM . J Clin Virol 2011 52 Suppl 1 S45-9 BACKGROUND: The HIV-1 Western blot (WB) and immunofluorescence assay used to confirm HIV infections are less sensitive during seroconversion than immunoassays (IAs) used for screening. An alternative diagnostic algorithm has been proposed to detect early HIV-1 infection and differentiate HIV-1 from HIV-2. OBJECTIVES: We evaluated the performance of an algorithm with a third generation IA that when reactive was followed by a rapid test (Multispot) that differentiates HIV-1 from HIV-2. Multispot-reactive specimens were considered HIV-infected. Multispot-negative specimens were tested with a nucleic acid amplification test (NAAT) for resolution. STUDY DESIGN: WB-positive specimens [serum (n=2202), plasma (n=1109) and peripheral blood mononuclear cells (PBMCs) (n=1065)] were obtained from HIV-infected persons not taking antiretrovirals. HIV-uninfected specimens [plasma (n=1517) and PBMCs (n=1508)] with negative IA and NAAT results were obtained from blood donors. Specimens were tested with third generation IAs (Abbott rDNA, ADVIA Centaur, GS HIV1-2 Plus O, Ortho VITROS) in singlet, Multispot, and NAAT (APTIMA (RNA) and AMPLICOR (DNA)). We calculated algorithm sensitivity and specificity and the proportion of IA-reactive specimens requiring NAAT. RESULTS: Algorithm sensitivity was 99.95% with APTIMA and 100% with AMPLICOR. One WB-positive specimen reactive by all IAs and AMPLICOR was negative by Multispot and APTIMA. Algorithm specificity was 100% using APTIMA or AMPLICOR as NAAT. From 0.10% (Abbott) to 2.43% (VITROS) of IA-reactive specimens required NAAT. CONCLUSIONS: The proposed algorithm performs with high sensitivity and specificity in specimens from persons with established HIV infection and uninfected blood donors and appears to be a good alternative to the current algorithm. |
Evaluation of the performance characteristics of 6 rapid HIV antibody tests
Delaney KP , Branson BM , Uniyal A , Phillips S , Candal D , Owen SM , Kerndt PR . Clin Infect Dis 2011 52 (2) 257-63 BACKGROUND: Since 2002, the US Food and Drug Administration has approved 6 rapid human immunodeficiency virus (HIV) tests for use in the United States. To date, there has been no direct comparison of the performance of all 6 tests. METHODS: Persons known to be HIV-infected and persons who sought HIV testing at 2 clinical sites in Los Angeles, California, were recruited for evaluation of 6 rapid HIV tests with whole blood, oral fluid, serum, and plasma specimens. Sensitivity and specificity of the rapid tests were compared with viral lysate and immunoglobulin (Ig) M-sensitive peptide HIV enzyme immunoassays (EIAs). RESULTS: A total of 6282 specimens were tested. Sensitivity was >95% and specificity was >99% for all rapid tests. Compared with the IgM-sensitive EIA, rapid tests gave false-negative results with an additional 2-5 specimens. All rapid tests had statistically equivalent performance characteristics, based on overlapping confidence intervals for sensitivity and specificity, compared with either conventional EIA. CONCLUSIONS: All 6 rapid tests have high sensitivity and specificity, compared with that of conventional EIAs. Because performance was similar for all tests and specimen types, other characteristics, such as convenience, time to result, shelf life, and cost will likely be determining factors for selection of a rapid HIV screening test for a specific application. |
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- Page last updated:Oct 28, 2024
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