The outbreak of SARS-CoV-2, the virus that causes COVID-19, led to a wealth of questions on how to manage the virus. Many of these questions can be answered with the help of diagnostic tests.
There's a growing variety and availability of tests related to SARS-CoV-2. All types of tests can help healthcare providers make more accurate diagnosis, support better management of individual patients and provide better guidance to manage population risk.
Diagnosing active infections and managing resolved infections require different technologies.
Bullard J, Dust K, Funk D, et al. Predicting infectious SARS-CoV-2 from diagnostic samples. Clinical Infectious Diseases. 2020/05/22/ 2020.
Woelfel R, Corman VM, Guggemos W, Seilmaier M, et al. Clinical presentation and virological assessment of hospitalized cases of coronavirus disease 2019 in a travel associated transmission cluster. 2020. medRxiv 2020.03.05.20030502.
Weiss A, Jellingso M, Sommer MOA. Spatial and temporal dynamics of SARS-CoV-2 in COVID-19 patients: A systematic review and meta-analysis. EBioMedicine. Aug 2020;58:102916.
Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020/06/09/ 2020;323(22):2249-2251.
Zou L, Ruan F, Huang M, et al. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. Mar 19 2020;382(12):1177-1179.
RT-PCR tests detect the presence of SARS-CoV-2 based on its genetic make up (RNA).
Antigen tests detect certain proteins of the SARS-CoV-2 virus.
Antibody tests measure the body's immune response to SARS-CoV-2 antigens, for instance the nucleocapsid or the spike protein. (We distinguish between qualitative (providing a yes/no result) and quantitative (measure the amount of antibodies) antibody tests.)
Depending on the technology, different samples may be collected.
Different healthcare settings require different instruments and tests.
Clinical or medical labsoffer a wide range of tests for many patient samples obtained elsewhere and sent to the lab.
Theinstruments in labsare usually highly automated and designed to process large numbers of patient samples.
Near-patient or Point of Care (PoC)facilities like doctors' offices or emergency departments usually offer a limited range of tests for individual patients visiting the facility.
The tests forPoCfacilities are designed for smaller testing volumes, with shorter time to test results, helping expedite clinical decision making. They can be used in settings around the world.
Hometesting kits, also referred to as patient-self tests, usually can be fully self-administrated by individuals. These tests aim to detect the presence of a target causing one specific medical condition.
Hometesting kits are designed to test one single patient and provide results quickly. The ease of use allows for more frequent testing.
The selection of the appropriate test also depends on the respective question one wants to answer.
Testing for symptomatic patients to potentially guide treatment
Managing exposed individuals and essential workers
Testing of asymptomatic individuals to contain disease spread and potentially manage outbreaks
Understanding disease prevalence in order to advise governments, health institutions and healthcare industry
Identifying recovering patients who could potentially be serum and plasma donors for developing treatments for COVID-19
Supporting the development of vaccines through tests that measure levels of antibodies to the virus
Helping with the development of treatments for infected patients
Identifying active or past infections to support better decision making and pandemic management
Help facilitate contact tracing and surveillance
Expand access to testing
Meeting the testing needs across the healthcare continuum requires a broad SARS-CoV-2 diagnostics portfolio.