Validation Protocol for COVID-19 Diagnostic Items, Nepal

RT-PCR Kits

• US-FDA approved and WHO listed or recommended kits will not require validation.
• CE-IVD approved/ Non-US-FDA approved/ Indigenous: Kits will require validation

RNA Extraction

• US-FDA approved and WHO listed or recommended kits will not require validation.
• CE-IVD approved/ Non-US-FDA approved/ Indigenous Kits: Kits will require validation.

VTM Kits

• US-FDA approved and WHO listed or recommended kits will not require validation.
• CE-IVD approved/ Non-US-FDA approved/ Indigenous Kits: Kits will require validation

Antigen kits

• US-FDA approved and WHO listed or recommended kits will not require validation.
• CE-IVD approved/ Non-US-FDA approved/ Indigenous Kits: Kits will require validation

Antibody kits

• US-FDA approved and WHO listed or recommended kits will not require validation.
• CE-IVD approved/ Non-US-FDA approved/ Indigenous Kits: Kits will require validation.

Others

• If NPHL considers any other non-FDA and non-WHO WHO listed or recommended technologies may be appropriate for Nepal, NPHL can request HTAC/ MOHP to facilitate the approval process.
• If a non-government entity wants to bring a new technology, which is not approved by the FDA or WHO, for research purpose, that entity can do so by submitting proper application to the NHRC stating the purpose of research. If the new technology is planned to be used and marketed in Nepal, the application must get approval by both HTAC and NPHL.

AGENCIES ELIGIBLE FOR REQUESTING FOR VALIDATION:

• Supplier/ Manufacturer of kits
• Logistic management division, DOHS

PROCEDURE FOR VALIDATION

• Government bodies should come through Logistic management division, DoHS for requesting validation of available kits
• Manufacturer or supplier can directly approach NPHL for kit validation
• Any organization requesting kit validation shall send request (PCR kits/ RNA extraction kits/ VTM) to NPHL via email ([email protected]) and also submit written request letter.

COST

• For Government bodies: No cost will be charged
• For suppliers/ manufacturers: RS.30,000 ( for each component)

Minimum requirement to accept a kit for validation

The kit should have a fulfill requirement of minimum sensitivity and specificity to be accepted for validation. This will depend upon the accepted specification
by DOHS.

More Info: Download Protocol