Part 1) Establishing analytical performance characteristics.
https://www.who.int/publications/i/item/9789241513814
Aspect | Testing requirements | Notes on testing requirements | Source Documents |
1.1 Specimen type and collection | |||
1.1.1 Demonstration of equivalence between contrived specimens and clinical specimens | Equivalence between contrived specimens and clinical specimens shall be demonstrated to enable contrived specimens to be used instead of clinical specimens in certain analytical HPV test analytical studies. For example: Performance can be compared by testing; • serial dilutions of clinical HPV positive cervical specimens with a targeted level of analyte; and • serial dilutions of contrived specimens derived from either, HPV infected cell lines, HPV genomic DNA plasmids or RNA transcripts in sample collection buffer with targeted levels of analyte (see note 4). Equivalence shall be determined for each reportable type or type group (e.g. HPV 16, HPV 18, etc.), as appropriate. For assays that detect more than 1 genotype, but do not differentiate the genotype, the justification as to whether to study each genotype shall be risk- and evidence based. | 1. The relationship between IVD performance in | Technical Guidance |
1.1.2 | For each claimed collection device or method (e.g. health Equivalence shall be determined for each reportable type | 1. Equivalence between specimen collection methods |
Aspect | Testing requirements | Notes on testing requirements | Source Documents |
1.2 Specimen storage and transport |
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1.2.1 | Real time studies taking into account: | 1. Recommended storage conditions should be |