key: cord-0953163-ij1hnuz2 authors: SoRelle, Jeffrey A.; Mahimainathan, Lenin; McCormick-Baw, Clare; Cavuoti, Dominick; Lee, Francesca; Thomas, Abey; Sarode, Ravi; Clark, Andrew E.; Muthukumar, Alagarraju title: Saliva for use with a point of care assay for the rapid diagnosis of COVID-19 date: 2020-09-08 journal: Clin Chim Acta DOI: 10.1016/j.cca.2020.09.001 sha: 8453d803e4cdbac8a223023d8531c1a43a4a9bd5 doc_id: 953163 cord_uid: ij1hnuz2 nan Letter to the Editor 2 Saliva for use with a point of care assay for the rapid diagnosis of COVID-19 3 Dear Editor: 4 Access to rapid and accurate testing is essential to limit the community spread of severe 5 acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and curtail COVID-19 resurgence. 6 The development of point of care (POC) testing platforms can facilitate rapid clinical decision 7 making and alleviate testing backlogs in centralized laboratories (1). The Abbott ID Now 8 (Abbott Diagnostics) is a POC isothermal amplification-based platform that detects SARS-CoV-9 2 in approximately 5 min, and is used in pharmacies, hospitals, and outpatient settings in all 50 10 states (2). Recently, concerns regarding IDNOW sensitivity compared to RT-PCR assays have been 12 raised (3). In response, the manufacturer no longer endorses the use nasopharyngeal swabs 13 (NPS) collected in viral transport media (VTM). However, any reflexive or confirmatory testing 14 requires recollection of an additional specimen. This not only poses additional risk of exposure 15 to the patient and health care workers, but also burdens already thin resources. Because of these limitations, laboratories continue to explore the utility of alternative Chart review of all FN samples in this work revealed a majority (n=6/9) of patients were 46 tested >2 weeks after symptom onset while 2 patients tested positive by NPS on a qPCR assay within 2 48 days of the saliva sample being collected. One patient lacked specific symptoms onset time but 49 had close contacts who were COVID-19 positive, so they may have been infected much earlier A liver transplant recipient was 10 days from symptom onset. The last patient had no previous COVID-19 diagnosis, but had a two-week atypical presentation of weakness and diarrhea before 52 coming to the ED. Radiographic exam revealed subtle hazy opacities of the lung base indicative 53 of minor respiratory disease Saliva contains digestive enzymes which could potentially affect specimen stability 55 during self-collection and transport. To investigate this, six SARS-CoV-2-positive saliva 56 specimens were evaluated daily by the IDNOW for 5-days post-collection stored at room 57 temperature (20-22°C). All specimens remained positive during serial testing over that time Easily collected specimens like saliva are 1 solution. Many FN patients 61 presented after 2 weeks of symptom onset, when viral loads are decreasing (6). Therefore, the and RT-PCR comparison studies indicate saliva as a matrix is stable MD 1, * 67 Lenin Mahimainathan, PhD, MB(ASCP) 1, * 79 Alagarraju.Muthukumar@UTSouthwestern.edu 80 Acknowledgments: The authors thank Anjali Bararia MS, M(ASCP) Molecular and Serological Tests for COVID-19 Comparative Review of SARS-CoV-2 Coronavirus Laboratory and Point-of-Care Diagnostics An update on Abbott's work on COVID-19 testing Comparison of two 92 commercial molecular tests and a laboratory-developed modification of the CDC RT-PCR assay for the detection of SARS-CoV-2 Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 97 from nasopharyngeal and nasal swabs from symptomatic patients Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2 Interpreting Diagnostic Tests for SARS-CoV-2 Table 1: Saliva as sample type for IDNOW COVID-19 assay performance comparison against 108 the Abbott RealTime SARS-CoV-2 and Cepheid Xpert® Xpress SARS-CoV-2 Real-Time PCR