Lab Matters Fall 2020 | Page 21

INDUSTRY MATTERS the qualitative and semi-quantitative detection of IgG class antibodies against the RBD , S1 , S2 , and nucleocapsid protein , providing a composite and individual test results for these targets . Initial performance data of this fully automated multiplex assay indicates high sensitivity ( 96.3 %, 15 days after symptoms onset ) and specificity ( 99.8 %) ( data on file ).

Though a wide range of NAAT , antigen and antibody-based assays are currently available for COVID-19 diagnosis and monitoring , additional data from large clinical studies is needed so that clinicians and public health officials can properly interpret assay results and understand when to use the various options for best patient care . n

References

1 . COVID-19 Dashboard by the Center for Systems Science and Engineering ( CSSE ) at Johns Hopkins University ( JHU ). [ Accessed Nov 17 , 2020 .] https :// coronavirus . jhu . edu / map . html .

2 . Janeway CA Jr , Travers P , Walport M , Shlomchik MJ . 2001 . Immunobiology : The Immune System in Health and Disease . 5th edition . New York : Garland Science .

3 . Havers FP , Reed C , Lim T , et al . 2020 . Seroprevalence of Antibodies to SARS-CoV-2 in 10 Sites in the United States . JAMA Intern Med . DOI : 10.1001 / jamainternmed . 2020.4130 .

4 . Interim Guidelines for COVID-19 Antibody Testing . [ Accessed August 10 , 2020 ]. https :// www . cdc . gov / coronavirus / 2019-ncov / lab / resources / antibody-testsguidelines . html .

5 . FAQs on Testing for SARS-CoV-2 . [ Accessed Sept 1 , 2020 ]. https :// www . fda . gov / medical-devices / coronavirus-covid-19-and-medical-devices / faqs-testing-sars-cov-2 .

6 . Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19 : Serologic Testing . August 18 , 2020 . IDSA . [ Accessed Sept 1 , 2020 ]. https :// www . idsociety . org / practice-guideline / covid-19-guideline-serology /.

7 . Deeks JJ , Dinnes J , Takwoingi Y , Davenport C , Spijker R , Taylor-Phillips S , Adriano A , Beese S , Dretzke J , Ferrante di Ruffano L , et al . 2020 . Antibody tests for identification of current and past infection with SARS-CoV-2 . Cochrane Database of Systematic Reviews . Issue 6 . Art . No .: CD013652 . DOI : 10.1002 / 14651858 . CD013652 .

8 . Platelia SARS-CoV-2 IFU . [ Accessed Sept 1 , 2020 ]. https :// www . fda . gov / media / 137493 / download .

9 . Charlton CL ., Kanji JN , Johal K , Bailey A , Plitt SS , McDonald C , Kunst A , Buss E , Burnes LE , Fonseca K , et al . 2020 . Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 antibodies . Journal of Clinical Microbiology . DOI : 10.1128 / JCM . 01361-20 .

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