TPP: For point of care test for suspected COVID-19 cases and their close contacts to diagnose acute SARS-CoV-2 infection in areas where reference assay testing is unavailable, or turnaround times obviate clinical utility

Suspected COVID-19 cases and their close contacts to diagnose acute SARS-CoV-2 infection in areas where reference assay testing is unavailable, or turnaround times obviate clinical utility

Minimum/Acceptable: In areas with confirmed SARS-CoV-2 community wide transmission or confirmed outbreaks in closed or semi-closed communities and in high risk groups: Early detection of SARS-CoV-2 cases where molecular/reference assays are not available or services are overloaded, leading to turnaround times that are not useful for guiding clinical case management and infection control measures. In suspected SARS-CoV-2 outbreak situations: multiple positive cases highly suggestive of SARS-CoV-2 Monitor trends in disease incidence. Preferred/Optimal/Ideal: In areas with confirmed SARS-CoV-2 community wide transmission or confirmed outbreaks in closed or semi-closed communities and in high risk groups: Early detection of SARS-CoV-2 cases where molecular/reference assays are not available or services are overloaded, leading to turnaround times that are not useful for guiding clinical case management and infection control measures. In suspected SARS-CoV-2 outbreak situations: multiple positive cases highly suggestive of SARS-CoV-2 Monitor trends in disease incidence.

Minimum/Acceptable: Patients with acute or subacute respiratory symptoms or fever or other suspicious symptoms (diarrhoea, anosmia) and either a known contact with a confirmed or probable COVID-19 patient or living in an area of cluster or community transmission, and close contacts (with or without symptoms) of index patients (confirmed COVID-19 patients). Preferred/Optimal/Ideal: Patients with acute or subacute respiratory symptoms or fever or other suspicious symptoms (diarrhoea, anosmia) and either a known contact with a confirmed or probable COVID-19 patient or living in an area of cluster or community transmission, and close contacts (with or without symptoms) of index patients (confirmed COVID-19 patients).

Minimum/Acceptable: Nasopharyngeal, oropharyngeal swab (or wash) nasal swab (anterior nares or mid-turbinate), nasal wash, sputum. Single swab and minimal extraction buffer/diluent. Preferred/Optimal/Ideal: Anterior nares, saliva/oral fluid, sputum. Single swab and minimal extraction buffer/diluent.

Minimum/Acceptable: The tests can be performed outside laboratories including at routine and ad-hoc triage/screening points of health care facilities such as emergency units, mobile units and in the community (contact tracing) by health care workers or laboratory technicians with appropriate training in sample collection, biosafety and in the use of the test. Preferred/Optimal/Ideal: Same as acceptable but can be self-administered and/or performed by trained lay workers (volunteer/community health workers).

Clinical sensitivity:: Minimum/Acceptable: >=80%. Preferred/Optimal/Ideal: >=90%. Clinical specificity:: Minimum/Acceptable: >=97%. Preferred/Optimal/Ideal: >97%. Time to results:: Minimum/Acceptable: <=40 minutes. Preferred/Optimal/Ideal: <=20 minutes.

Stability and storage:: Minimum/Acceptable: 12 months at 4-30°C; tolerates brief periods > 40°C; humidity 75%+ 5% any associated equipment must meet or exceed these requirements. Preferred/Optimal/Ideal: 18-24 months at 4-40°C; tolerates freezing and brief periods > 45°C; humidity 75%+ 5%.; any associated equipment must meet or exceed these requirements. 

ID_250