Rapid collection and testing of appropriate specimens from patients meeting the suspected case definition for COVID-19 is a must for outbreak control and clinical management. Molecular testing is the current recommended method for the identification of infectious cases. Serological assays and rapid test kits for antigen detection may play an important role in diagnosis, research, and surveillance but are not currently recommended.
Currently, laboratories are detecting unique gene sequences of SARS-CoV-2 using NAAT such as real-time reverse-transcription polymerase chain reaction (rRT-PCR) for the confirmation of COVID-19 cases. The viral genes targeted so far include the N, E, S, and RdRP genes.
A number of manufacturers are currently developing commercial test methods for the diagnosis of COVID-19 based on unique gene detection, antigen detection, or serological assays. Some of these test methods have got Emergency Use Authorization (EUA) from FDA.
So far, there are no FDA-approved diagnostics for COVID-19.
Most of these test methods detect SARS-CoV-2 nucleic acid in direct nasal, nasopharyngeal, or throat swabs and nasal, nasopharyngeal, or throat swabs eluted in viral transport media from individuals who are suspected of COVID-19
Recently, ABBOTT has launched rapid molecular testing for COVID-19. According to the manufacturer, ID NOW gives positive results within 5 minutes and a negative result in 13 minutes.
Some of the manufacturers are also evaluating performance using other respiratory specimens such as sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.
Tests for the detection of IgG/IgM
As of now, World health organization (WHO) has not endorsed any of these products yet [find more] but has activated the Emergency Use Listing (EUL) of the assays for the detection of SARS-CoV-2 nucleic acids.
| Test Name | Use | Manufacturer |
|---|---|---|
| qSARS-CoV-2 IgG/IgM Rapid Test | Qualitative test for the detection of IgM and IgG antibodies against SARS-CoV-2 in blood. | Cellex Inc. |