The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing (January 2021)

Abstract

Background Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. Objective The IDSA’s goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. Methods IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 17 diagnostic recommendations. Conclusions Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.

Second COVID-19 infection in a patient with granulomatosis with polyangiitis on rituximab

“…However, rapid tests are typically highly specific. 5 GPA flare was considered as a cause of her illness; however, the positive SARS-CoV-2 tests and improvement without immunosuppression argue against this. Corticosteroids are a known risk factor for severe COVID-19 6 ; however, she had not taken prednisone in the approximately 4 weeks preceding initial infection.…”

COVID-19 serological survey using micro blood sampling

“…2). The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19 currently make no recommendations for or against the use of capillary blood in serological assays due to a knowledge gap on the subject 6 . We hope that the success of our study begins to fill this knowledge gap, paving the way for further proof-of-concept studies using capillary blood.…”

“…5 Research Support Division, Occupational Health and Safety, OIST, Onna-son, Okinawa, Japan. 6 Research Support Division, Office of the Provost, OIST, Onna-son, Okinawa, Japan. 7 Institute of Biological Chemistry, Academia Sinica, Taipei, Taiwan.…”

Evaluating the home isolation of COVID-19 patients in primary care

“…The American Association of Infectious Diseases (IDSA) recommends testing nasopharyngeal specimens instead of the oropharyngeal specimen (or saliva) due to lower sensitivity to oropharyngeal specimens and lack data on the accuracy of saliva specimens [31]. Fang et al [34] reported that among 51 patients hospitalized in China with fever or acute respiratory symptoms and ultimately a positive PCR test, the initial PCR test was negative in 15 patients (29.0%), and they were subsequently diagnosed only after repeated tests.…”