Lab Matters Summer 2021 | Page 50

APHL 2021 Poster Abstracts
COVID-19
If any of the four antibody levels are positive , the antibody screen result is reported as positive . The individual antibody results can be reported semi-quantitatively in U / ml . To evaluate specificity , a total of 1,078 samples from patients with potentially crossreactant antibodies , as well as a total of 1557 samples from presumed healthy subjects and blood bank donors , were tested . All samples were collected prior to November 2019 . To test for clinical sensitivity , a total of 305 samples from subjects who had been identified as positive for SARS-CoV-2 by PCR testing were evaluated with the BioPlex 2200 SARS-CoV-2 IgG panel .
Results : BioPlex 2200 SARS-CoV-2 IgG panel exhibited an overall specificity of 99.8 % ( 1554 / 1557 ). The individual assay specificities for RBD IgG , S1 IgG , S2 IgG , and N IgG were all > 99.9 %. No significant cross-reactivity was observed . The CoV-2 IgG NPA , for all potentially cross-reactant samples , was 99.7 % ( 1,075 / 1,078 ). The CoV-2 IgG PPA for all samples ( N &# 3f305 ) was 96.3 &# 37 ; ( 237 / 246 ) at > 15 days , 100 % ( 27 / 27 ) at 8-14 days and 84.4 % ( 27 / 32 ) at 0-7 days . The sensitivity for samples > 15 days for the individual analytes RBD IgG , S1 IgG , S2 IgG , and N IgG were 95.5 %, 93.9 %, 50.4 %, and 93.9 %, respectively . As each patient can generate a unique antibody response to any or all of the analytes in this panel , the individual assay sensitivities varied , as expected , when compared to PCR-positive COVID-19 patients .
Conclusion : The BioPlex 2200 SARS-CoV-2 IgG Panel demonstrated excellent specificity and high sensitivity . The BioPlex 2200 System offers practical advantages that allow for rapid , fully automated , and simultaneous evaluation of IgG antibodies to all four key SARS- CoV-2 proteins RBD , S1 , S2 , and N .
Presenter : Heidi Scholz , Bio-Rad Laboratories , heidi _ scholz @ bio-rad . com
SARS-CoV-2 Point-of-Care Antigen Testing and Training in Congregate Living Facilities
P . Seabourn , E . Desmond and J . Kettlewell , Hawaii State Laboratory Division , Pearl City , HI
The COVID-19 pandemic has emphasized the need for rapid and accurate testing for SARS-CoV-2 and emphasized that without high quality testing at the laboratory levels , modern public health interventions are impossible to carry out . While viral cultures and RT-PCR remain the gold standard for diagnosis of COVID-19 , pointof-care antigen test are inexpensive , offer rapid turnaround time , and do not require viral transport media , allowing for testing to occur many types of locations . Antigen testing can be used supplement other testing efforts , particularly in settings where RT-PCR testing capacity is limited , or results are delayed . While antigen test typically have a lower sensitivity , the specificity is on par with RT-PCR testing and offers a viable alternative to helping mitigate SARS-CoV-2 transmission . Similar to other types of laboratory testing , antigen testing platforms are subject to operator error due to insufficient training , which can lead to inaccurate results ( i . e ., false positives and negatives ), and increased spread of SARS-CoV-2 . To mitigate this problem , I provided training to congregate living facilities ( i . e ., nursing homes , correctional facilities , national guardsman , Hawaii Department of Health and department of education workers ) on SARS-CoV-2 point-of-care antigen testing platforms such as Abbott BinaxNOW , Abbott IDNOW , and BD-Veritor . I developed educational materials on the various antigen testing platforms , which included PowerPoint presentations , how-to videos , and training quizzes to test for competency . I also developed testing guidelines that emphasize orthogonal antigen testing algorithms which aimed to further improve antigen testing specificity and reduce false positive results . In addition , I provided virtual consultations to congregate living facilities to ensure accurate reporting to the disease outbreak control division ( DOCD ) in Hawaii , and the COVID-19 module offered by CDC . As an Hawaii Department of Health ( HDOH ) point of contact , I was available for troubleshooting potential problems with antigen testing platforms and identifying any supply chain issues to ensure facilities had the materials to provide SARS-CoV-2 testing . Point-ofcare antigen test offer a rapid diagnostic that can augment nucleic acid testing measures , and allows for early reporting , quarantine , and treatment . My position as an associate has enabled HDOH to expand testing in congregate living facilities , thus further mitigating the spread of COVID-19 .
Presenter : Priscilla Seabourn , Hawaii State Laboratory Division , pseabour @ hawaii . edu
Development and Evaluation of a Mass Specimen Collection Event in Response to the COVID-19 Pandemic in Nebraska
K . Stiles and P . Iwen , Nebraska Public Health Laboratory , Omaha , NE
Background / Introduction : Previous mass collection exercises that occurred in Nebraska provided a foundation for better community or statewide collection settings and were flexible enough to advance and expand into CoVID-19 collection / transport protocols . Escalating to the next level , however , did emphasize that certain time-consuming modifications were needed to the original plan . This study defined some opportunities to evaluate and modify these previous plans as we participated in the ongoing COVID-19 pandemic .
Methods : The Nebraska Public Health Laboratory ( NPHL ), the Douglas County Health Department ( DCHD ), the Nebraska Department of Health & Human Services ( NEDHHS ) and the Nebraska Army National Guard ( ANG ) collaborated in establishing processes for the large-scale collection of specimens to detect for SARS-CoV-2 . The pre-analytical modifications to previous mass collection exercises involved multiple areas to include the identification of strategically located specimen collection sites ( DHHS and ANG ), specimen collection team organizations ( ANG ), a digitalized program and QR coding process for self-registration ( NPHL ), supply chain processes to procure the necessary supplies for collection ( PPE , specimen collection kits , labeling ) and packaging and shipment processes to transport specimens to the NPHL ( shipping containers and courier services ). In addition , interaction with the Infection Control Assessment and Promotion Program ( ICAP ) provided needed guidance for infection prevention and biosafety during the collection process .
Results : The pre-analytical processes showed the importance of communication among a variety of state organizations ( to include the NPHL ) and the need for continued review of processes as they occurred . Despite multiple years of full-scale chemical event exercises , participation in a real-life pandemic event emphasized the challenges that occur and that flexibility to make the necessary changes was essential . The experiences learned can be used in the future to provide for a more realistic preparedness planning to match the expediential laboratory testing demands of a worldwide event .
Conclusion : The lessons learned from the COVID-19 pandemic can only enhance preparedness planning of mass collection and transport of clinical specimens in not only biological pandemics , but chemical
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LAB MATTERS Summer 2021