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CHARACTERISTICS OF THE SAMPLE ADEQUACY CONTROL (SAC) IN THE CEPHEID XPERT® CCT/NG ASSAY IN FEMALE URINE SPECIMENS
Autor
Afiliación
University of California. Fielding School of Public Health. Department of Epidemiology. Los Angeles, USA.
University of California. David Geffen UCLA School of Medicine. USA.
University of California. David Geffen UCLA School of Medicine. USA.
University of California. David Geffen UCLA School of Medicine. USA.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brazil.
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brazil.
University of California. David Geffen UCLA School of Medicine. USA.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.
National Institutes of Health. Eunice Kennedy Shriver National Institute of Child Health and Human Development. USA.
University of California. David Geffen UCLA School of Medicine. USA.
University of California. David Geffen UCLA School of Medicine. USA.
University of California. David Geffen UCLA School of Medicine. USA.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brazil.
Hospital Federal dos Servidores do Estado. Rio de Janeiro, RJ, Brazil.
University of California. David Geffen UCLA School of Medicine. USA.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.
National Institutes of Health. Eunice Kennedy Shriver National Institute of Child Health and Human Development. USA.
Resumen en ingles
Background: The Xpert® CT/NG (Cepheid Sunnyvale, CA) is a rapid, fully automated real-time polymerase chain reaction test that simultaneously detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). It has high sensitivity and specificity, but also includes a Specimen Adequacy Control (SAC). SAC controls for false negative results by confirming adequate patient sample and appropriate testing conditions. SAC is quantified by its cycle threshold (Ct), the number of cycles required to detect the presence of a single copy human gene. A lower SAC indicates an earlier Ct and more human cellular material detected. Our objectives were to describe the frequency and distribution of SAC Ct values and observe any correlations with detected infections. Methods: Urine samples from 1382 HIV-1-infected pregnant women, collected at the time of labor/delivery underwent Xpert® CT/NG testing. Mean SAC Ct values and standard deviation (SD) were calculated. Student’s t-test was used to compare mean SAC Ct values to a reference of urine samples negative for CT and NG. Results: The urine CT positivity was 17.9% (248/1382) and NG, 4.6% (63/1382). The mean SAC Ct value in urine from women without CT or NG was 28.09 (SD: 4.12) and higher than the mean SAC Ct value for CT positive specimens (27.29, SD: 3.84(P=.0054)), NG positive specimens (26.23, SD: 3.09(P<.0001)), specimens positive for both CT and NG (26.41, SD: 3.01(P=.0027)). Conclusion: Lower SAC Ct values were significantly associated with chlamydial and gonococcal infections. Further studies should be conducted to determine the utility of SAC Ct values for identifying the presence of increased human cellular material and infection.
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