TPP: For a test for diagnosis or confirmation of acute or subacute SARS-CoV-2 infection, suitable for low or high-volume needs

For diagnosis or confirmation of acute or subacute SARS-CoV-2 infection, suitable for low or high-volume needs.

Minimum/Acceptable: To detect the presence of virus component(s) to diagnose or confirm acute and subacute SARS-CoV-2 infection e.g. first two weeks since onset of symptoms in suspected cases or contacts (of probable or confirmed COVID-19 patients) with or without symptoms. Preferred/Optimal/Ideal: To detect the presence of virus component(s) to diagnose or confirm acute and subacute SARS-CoV-2 infection e.g. first two weeks since onset of symptoms in suspected cases or contacts (of probable or confirmed COVID-19 patients) with or without symptoms.

Minimum/Acceptable: Patients with acute or subacute respiratory symptoms or fever or other suspicious symptoms (anosmia, diarrhoea) and either having had a known contact with a probable or confirmed COVID-19 patient or living in an area of a cluster or community transmission and symptomatic, pre-symptomatic or asymptomatic close contacts. Suspected COVID-19 cases requiring confirmation (positive triage test but low PPV) or exclusion (negative triage test but low NPV) of COVID-19 infection. Preferred/Optimal/Ideal: Patients with acute or subacute respiratory symptoms or fever or other suspicious symptoms (anosmia, diarrhoea) and either having had a known contact with a probable or confirmed COVID-19 patient or living in an area of a cluster or community transmission and symptomatic, pre-symptomatic or asymptomatic close contacts. Suspected COVID-19 cases requiring confirmation (positive triage test but low PPV) or exclusion (negative triage test but low NPV) of COVID-19 infection.

Minimum/Acceptable: Any of the following: swabs – nasopharyngeal, oropharyngeal nasal; washes - oropharyngeal, nasal, bronchoalveolar; sputum. The minimal sample volume required to reach clinically relevant sensitivities and ideally would allow for repeat testing. Preferred/Optimal/Ideal: Sample types amenable to self-collection and/or easy to collect: saliva/oral fluid, stool; inactivated samples. Not applicable.

Minimum/Acceptable: High-volume needs: reference laboratories or ideally in district hospitals or mobile laboratories by laboratory technicians with appropriate training in sample collection, biosafety and in the use of the test. These labs can of course also serve low-moderate needs. Preferred/Optimal/Ideal: Low-volume needs/non-laboratory settings: outpatient clinics, emergency units at the point of care or near patient by health care workers or laboratory technicians with appropriate training in sample collection, biosafety and in the use of the test.

Clinical sensitivity:: Minimum/Acceptable: >=95%. Preferred/Optimal/Ideal: >=98%. Clinical specificity:: Minimum/Acceptable: >=99%. Preferred/Optimal/Ideal: >=99%. Time to results:: Minimum/Acceptable: < 4 hours (half day). Preferred/Optimal/Ideal: < 45 mins.

Stability and storage:: Minimum/Acceptable: 12 months, stable between 4-10°C, 70% humidity; 3000 meters altitude; Indicator of instability or expiration. Preferred/Optimal/Ideal: 18-24 months, stable between 4-40°C (no cold chain), 90% humidity; 3000 meters altitude; Indicator of instability or expiration.

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