Snapshot

The CRP for registration of WHO-prequalified IVDs pathway has been developed by the of WHO.

This pathway can be used where Primary health care: - intended for health posts, community health centres, doctors’ offices, outreach clinics, and ambulatory care - either no laboratories or only small laboratories with non-specialist staff General IVDs at primary care - hemoglobin, white blood cell count, peripheral blood film examination, albumin, bilirubin, glucose, HbA1c, lactate, blood typing/Rh typing, hCG pregnancy testing, urine dipstick/microscopy, and basic microbiology/parasitology screening Disease-specific IVDs at primary care: - tests for hepatitis B surface antigen - hepatitis B e antigen - anti-HCV - HIV antibodies - malaria tests - syphilis tests - related rapid diagnostic tests Health care facilities with clinical laboratories: - district, regional, provincial, specialized, and national reference laboratories where trained laboratory technicians and infrastructure are available IVDs at laboratory level: - more advanced chemistry, hematology, serology, microbiology, and parasitology tests, including tests that support diagnosis and monitoring of many conditions broader and more complex testing for HIV, TB, malaria, hepatitis, syphilis, and HPV, including reference and confirmatory-type assays .

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Target time assessment is .