Impact of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) vaccination on the incidence of coronavirus disease 2019 (COVID-19) among healthcare workers at an academic medical center in Vermont.

Infection prevention strategies and vaccination reduce risk of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) transmission to healthcare workers (HCWs). We describe coronavirus disease 2019 (COVID-19) incidence and vaccination rates in a cohort of HCWs at the University of Vermont Medical Center. Before vaccines, the HCW COVID-19 incidence paralleled that of the State of Vermont; after vaccination, incidence fell and remained low.

Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status.

The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers' in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2. The U.S. government's Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulates the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization (EUA) pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated, in order to continue to be marketed as an IVD in the United States. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists' Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.

Testing of integrated human papillomavirus mRNA decreases colposcopy referrals: could a change in human papillomavirus detection methodology lead to more cost-effective patient care?

OBJECTIVES: This study investigates potential colposcopy referral rates, as per the latest American Society for Colposcopy and Cervical Pathology recommendations, following the change in high-risk human papillomavirus (HR-HPV) detection methodology from Hybrid Capture 2 (HC2) to APTIMA at our institution. STUDY DESIGN: Rates of colposcopy referral were compared between two cohorts, each comprising all Pap samples with a diagnosis of atypical squamous cells of undetermined significance (ASCUS) tested for HR-HPV in our laboratory during a 12-month period. Cohorts I and II included Pap samples tested with HC2 (n = 1,856) and APTIMA (n = 1,651), respectively. The rates of quantity not sufficient (QNS) results were determined for all Pap samples during the same time periods. RESULTS: The proportion of HR-HPV-positive Pap samples with an ASCUS diagnosis was significantly lower with APTIMA (42%) than with HC2 (53%; p < 0.0001). APTIMA also resulted in a significantly lower QNS rate among all Pap samples (0.42 vs. 4.3% with HC2; p < 0.0001). CONCLUSION: The change in HR-HPV detection methodology from HC2 to APTIMA has led to a 21% reduction in colposcopy referrals and a 90% decrease in QNS rates at our institution. The new methodology has resulted in more cost-effective patient care and fewer insufficient samples requiring repeat HR-HPV testing.

Evaluation of the Verigene Gram-positive blood culture nucleic acid test for rapid detection of bacteria and resistance determinants.

Rapid identification of pathogens from blood cultures can decrease lengths of stay and improve patient outcomes. We evaluated the accuracy of the Verigene Gram-positive blood culture (BC-GP) nucleic acid test for investigational use only (Nanosphere, Inc., Northbrook, IL) for the identification of Gram-positive bacteria from blood cultures. The detection of resistance genes (mecA in Staphylococcus aureus and Staphylococcus epidermidis and vanA or vanB in Enterococcus faecium and Enterococcus faecalis) by the BC-GP assay also was assessed. A total of 186 positive blood cultures (in BacT/Alert FA bottles) with Gram-positive cocci observed with Gram staining were analyzed using the BC-GP assay. The BC-GP results were compared with the identification and susceptibility profiles obtained with routine methods in the clinical laboratory. Discordant results were arbitrated with additional biochemical, cefoxitin disk, and repeat BC-GP testing. The initial BC-GP organism identification was concordant with routine method results for 94.6% of the blood cultures. Only 40% of the Streptococcus pneumoniae identifications were correct. The detection of the mecA gene for 69 blood cultures with only S. aureus or S. epidermidis was concordant with susceptibility testing results. For 3 of 6 cultures with multiple Staphylococcus spp., mecA detection was reported but was correlated with oxacillin resistance in a species other than S. aureus or S. epidermidis. The detection of vanA agreed with susceptibility testing results for 45 of 46 cultures with E. faecalis or E. faecium. Comparison of the mean times to results for each organism group showed that BC-GP results were available 31 to 42 h earlier than phenotypic identifications and 41 to 50 h earlier than susceptibility results.

Comparison of Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 (CAP/CTM v2.0) with other real-time PCR assays in HIV-1 monitoring and follow-up of low-level viral loads.

Viral load monitoring of HIV-1 has become standard of care in HIV-1 positive patients. In this study, we evaluated the performance characteristics of the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 (CAP/CTM v2.0) in comparison with Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 1.0 (CAP/CTM v1.0) and Abbott RealTime HIV-1 assay (m2000), with special emphasis on the quantitation of clinically controversial low-level viral loads. The performance characteristics of CAP/CTM v2.0 were confirmed by the validation study. All three assays performed comparably, with Abbott m2000 showing slightly decreased sensitivity for detection of viral loads close to the lower limit of quantitation. Follow-up of patients with low-level viral loads revealed that some of those represent single viral blips; however, a significant portion of these patients have intermittent or persistent low-positive viremia. We conclude that CAP/CTM v2.0 is an accurate and reliable assay for HIV-1 viral load monitoring.

Bloodstream infection caused by nontoxigenic Corynebacterium diphtheriae in an immunocompromised host in the United States.

Corynebacterium species are well-known causes of catheter-related bloodstream infections. Toxigenic strains of Corynebacterium diphtheriae cause respiratory diphtheria. We report a bloodstream infection caused by a nontoxigenic strain of C. diphtheriae and discuss the epidemiology, possible sources of the infection, and the implications of rapid species identification of corynebacteria.