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Item Erratum for Pancholi et al., "Multicenter Evaluation of the Simplexa VZV Direct Assay for Detection of Varicella-Zoster Virus in Cerebrospinal Fluid and Lesion-Swab Specimens"(American Society for Microbiology, 2022) Pancholi, P.; Relich, R.F.; Chandrasekaran, S.; Dunn, J.J.; Granato, P.A.; Harrington, A.T.; Hansen, G.T.; Ledeboer, N.A.; Li, Q.; Sims, M.D.; Uphoff, T.S.; Greene, W.; Young, S.; Dhiman, N.; Pathology and Laboratory Medicine, School of MedicineErratum for: Multicenter Evaluation of the Simplexa VZV Direct Assay for Detection of Varicella-Zoster Virus in Cerebrospinal Fluid and Lesion-Swab Specimens. Pancholi P, Relich RF, Chandrasekaran S, Dunn JJ, Granato PA, Harrington AT, Hansen GT, Ledeboer NA, Li Q, Sims MD, Uphoff TS, Greene W, Young S, Dhiman N. J Clin Microbiol. 2022 Apr 20;60(4):e0235521. doi: 10.1128/jcm.02355-21. Epub 2022 Mar 14.Item Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System(American Society for Microbiology, 2019-01-30) Emery, C. L.; Relich, R. F.; Davis, T. H.; Young, S. A.; Sims, M. D.; Boyanton, B. L.; Pathology & Laboratory Medicine, IU School of MedicineGroup B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis in developed countries. Recommendations for antepartum GBS detection include enriched culture with several options for identifying GBS, some of which are time-consuming. To reduce the time for identification and determination of the maternal GBS colonization status, rapid nucleic acid amplification technologies have been developed and commercialized. For rapid detection of GBS, a three-site clinical study was conducted to evaluate the NeuMoDx GBS assay, a real-time PCR test performed for vaginal/rectal swab specimens in Lim broth enrichment culture on the NeuMoDx 288 molecular system (NeuMoDx system); these data were used to a support 510(k) submission. A total of 1,250 eligible remnant samples were prospectively enrolled and tested during the study. The results of the PCR assay were compared to the results of the Centers for Disease Control and Prevention (CDC)-recommended enriched-culture method, which served as the gold standard reference method for the study. The NeuMoDx GBS assay results yielded a sensitivity of 96.9% (95% confidence interval [CI] = 94.1 to 98.4), specificity of 96.0% (95% CI = 94.6 to 97.1), and a total agreement with the reference method of 96.2% (95% CI = 93.8 to 98.3). NeuMoDx GBS assay results were also compared to results obtained using the BD MAX GBS assay on the BD MAX system. The two systems demonstrated a total percent agreement of 98.0% (95% CI = 95.5 to 100.0). The performance of the NeuMoDx GBS assay implemented on the NeuMoDx system compared favorably to the CDC enriched-culture method and to the BD MAX GBS assay.Item Multicenter Evaluation of the Simplexa VZV Direct Assay for Detection of Varicella-Zoster Virus in Cerebrospinal Fluid and Lesion-Swab Specimens(American Society for Microbiology, 2022) Pancholi, P.; Relich, R.F.; Chandrasekaran, S.; Dunn, J.J.; Granato, P.A.; Harrington, A.T.; Hansen, G.T.; Ledeboer, N.A.; Li, Q.; Sims, M.D.; Uphoff, T.S.; Grene, W.; Young, S.; Dhiman, N.; Pathology and Laboratory Medicine, School of MedicineVaricella-zoster virus (VZV) is the etiologic agent of varicella (chickenpox) and herpes zoster (shingles) infections commonly involving skin, mucous membranes, and less frequently the central nervous system. Traditional methods for the laboratory diagnosis of these infections are time-consuming, labor-intensive, and often insensitive. As such, these tests are being replaced by more sensitive and rapid molecular methods. This study evaluated the performance of two different molecular assays, the Simplexa VZV Direct and Simplexa VZV Swab Direct, to detect VZV DNA in cerebrospinal fluid (CSF) and lesion-swab specimens, respectively. The Simplexa VZV Direct and Simplexa VZV Swab Direct assays were compared against individual composite reference methods that varied depending on the sample cohort examined. A total of 883 CSF and 452 cutaneous and mucocutaneous prospective, retrospective, and contrived specimens were evaluated in this multicenter study. The results of this study showed that the Simplexa assays demonstrated near perfect agreement (k = 0.98) compared to the composite reference methods for the detection of VZV in CSF and lesion swab specimens. A further comparison between the standard of care molecular assays employed at the site of specimen collection and the Simplexa assays demonstrated excellent agreement (k = 1.0). The Simplexa assays offer rapid and reliable alternatives for the detection of VZV in certain clinical specimens without the need for nucleic acid extraction.