Table 3.
Selected target product profile characteristics for high- and low-throughput diagnostic SAR-CoV-2 detection testing
| World Health Organization |
Medicines and Healthcare Products Regulatory Agency |
|||
|---|---|---|---|---|
| Scope | Desired | Acceptable | Desired | Acceptable |
| Intended use | To detect the presence of virus components to diagnose or confirm acute and subacute SARS-CoV-2 infection. | Multiplex—determining current infection by detecting SARS-CoV-2 virus, differentiate other respiratory infections. | Determining current infection by detecting SARS-CoV-2 virus. | |
| Target population | Patients with acute or subacute respiratory symptoms; suspicious symptoms and contact with confirmed or probable case/living in the area of cluster/community transmission. | People with/without clinical signs associated with SARS-CoV-2 infection. | People with clinical signs associated with SAR-CoV-2 infection. | |
| Target settings/users | High volume: reference laboratories/district hospitals/mobile laboratories. Laboratory technicians. Low volume: outpatient clinics, point of care or near-patient settings. Laboratory technicians/health care workers. | Health care and medical laboratories. Trained health care professional (governed by professional standards authority) and suitably trained and assessed lab technician or scientist. | ||
| Target analyte | Must have at least one target specific for SARS-CoV-2 RNA or protein/antigen. | Dual (or more) SARS-CoV-2 RNA. Multiplex panel for a range of infectious respiratory viruses. | Single SARS-CoV-2 RNA. | |
| Target type | Samples amenable to self-collection: saliva/oral fluid, stool; inactivated samples. | NP or OP or nasal swab. Washes-nasal, oropharyngeal, BAL. Sputum | Oral fluid | NP or OP, lower respiratory tract aspirate, BAL, nasopharyngeal wash/aspirate, or nasal aspirate. |
| Clinical sensitivity | ≥98% | ≥95% | >99%. 95% two-sided confidence interval > 97%a | >95%. 95% two-sided confidence interval > 90%a |
| Clinical specificity | ≥99% | ≥99% | >99%. 95% two-sided confidence interval > 97%b | >95%. 95% two-sided confidence interval > 90%b |
| Analytical sensitivity (LOD) | 1 × 102 copies per ml in upper/lower respiratory tract specimens, stool | 1 × 103 copies per ml in any respiratory tract specimen. | ≤100 SARS-CoV-2 copies/ml | ≤1000 SARS-CoV-2 copies/ml |
| Technical failure rate | NA | NA | <0.2% | <1% |
| Turnaround time | < 45 min | < 4 h | < 90 min | < 5 h |
| Throughput | High volume: 200–500 tests in 4 h. Low Volume: 6 patients in 45 min | High volume: 50–150 tests in 4 h. Low volume: 1–4 patients per 45 min | > 200 tests in unit per 4 h | > 50 tests in unit per 4 h |
Abbreviations: BAL, bronchoalveolar; LOD, limit of detection; NP, nasopharyngeal swab; OP, oropharyngeal swab.
a
Determined using at least 150 positive clinical samples covering a clinically meaningful range of viral loads.
b
Determined using at least 250 negative clinical samples.