Scientific basis |
Detection of SARS-CoV-2 viral sequences by nucleic acid amplification tests in respiratory tract specimens. |
Detection of SARS-CoV-2 viral proteins (antigens) in respiratory tract specimens. |
Detection of antibodies produced by the human body in response to infection with the SARS-CoV-2. |
Aim of test |
Diagnosis of SARS-CoV-2 infection |
Diagnosis of SARS-CoV-2 infection |
Check for previous SARS-CoV-2 infection as part of epidemiological investigations |
Sample type |
Nasopharyngeal (NP), Oropharyngeal (OP), Midturbinate (MT) |
Nasopharyngeal (NP), Oropharyngeal (OP), Midturbinate (MT) |
Venous blood, fingerprick, for point-of-care testing (POCT) |
Turnaround time |
- 4-6 hours per run (lab)
- ~1 hour per run in POCT PCR or PCR that does not require separate extraction step (Cepheid)
|
- 15-30 minutes per run
- All kits are POCT, no analyser machines required for most kits
|
- Lab-based: 40-120 minutes per test; 100-200 tests per hour
- POCT: ~30 minutes per test
|
Clinical performance
(Sensitivity / Specificity) |
>99.5%/100% |
Variable sensitivity but generally higher sensitivity for individuals with high viral load.
WHO criteria for antigen-detecting rapid diagnostic tests: >80%/97% |
Performance of serologic assays varies widely in different testing groups (such as disease severity, age), timing of testing and the target viral protein.
In general, lab-based tests using venous blood has higher sensitivity/specificity than POCT. |
Examples of use cases and role in overall testing strategy |
- Symptomatic individuals
- Stay-Home Notice (SHN) exit swab
- Quarantine Order (QO) entry and exit swab
- Rostered routine testing
|
- Screening for pre-event testing, rostered routine testing
|
- Differentiate between acute and old infections in cases that test positive for COVID-19
|
Limitations |
- Unable to differentiate between acute and old infections due to persistent shedding of viral fragments among recovered individuals.
|
- Potentially high false negative rate in individuals with low viral load.
- Higher false positive rate than PCR tests.
|
- Unable to rule out acute/early infection if serology-negative.
|