Current best evidence for clinical care (more info)
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.
| Discipline / Specialty Area | Score |
|---|---|
| Emergency Medicine | |
| Allergy and Immunology | |
| Pediatric Hospital Medicine | |
| Pediatric Emergency Medicine | |
| Oncology - Hematology | |
| Pediatrics (General) | |
| Public Health | |
| Infectious Disease | |
| Rheumatology | |
| Hospital Doctor/Hospitalists | |
| Internal Medicine | |
This is a very helpful guideline for all practitioners in these trying times.
Accurate testing for COVID is essential, but there are currently many assays available and unclear scenarios. This guideline from the IDSA based on a systematic review using GRADE methodology provides key recommendations on testing. Unfortunately, the evidence quality was considered moderate to very low. NAAT testing is recommended in symptomatic patients with suspected COVID using nasopharyngeal, mid-turbinate, anterior nasal, saliva or a combined anterior nasal/oropharyngeal swab rather than an oropharyngeal swab alone. If suspicion of COVID is low, they recommend a single viral RNA test. If the patient is symptomatic and there is moderate-to-high suspicion, repeat viral testing is recommended. They also recommend RNA testing in asymptomatic patients with known or suspected exposure, but no testing in those with no known contact who are being hospitalized in areas with low prevalence. If prevalence is high or the patient is immunocompromised, then testing is recommended.
Detailed review of data on COVID-19 testing with reasonable recommendations.
As COVID-19 rapidly spread and became pandemic, an evidence-based rapid and accurate molecular diagnostic testing was required to confirm diagnosis and to develop an effective public health response to limit the spread. The IDSA panel critically appraised the available diagnostic literature and made SARS-CoV-2 testing recommendations. Since the quality of data is limited and COVID-19 is still unfolding, nucleic acid testing for all symptomatic individuals is recommended by the panel. There is a need to determine a well-defined reference standard for COVID-19 diagnostic testing.
This information is very important, because most doctors are familiar with the test to identify SARS-CoV-2 infection. However, the level of evidence is not known for most people.