الزامات سازمان بهداشت جهانی (WHO) برای کیت های تشخیصی پاپیلوماویروس انسانی (HPV)

Aspect

Testing requirements

Notes on testing requirements

Source Documents

1. The relationship between IVD performance in
claimed specimen types and contrived specimens
used for analytical studies shall be established. The
design of subsequent studies shall then take that
relationship into account.
2. If there is no equivalence between claimed specimen
types and contrived specimens, then the impact that
this will have on each subsequent performance claim
shall be fully understood and described.
3. Specimens should be chosen that are considered to
have low to moderate concentrations of the analyte
(include levels of analyte at relevant medical decision
points and near the cut-off decision point)
4. Equivalence may be established as part of analytical
sensitivity.

Technical Guidance
Series for WHO
Prequalification –
Diagnostic Assessment
TGS-3

1.1.2
Demonstration
of equivalence
between
specimen
collection
methods

For each claimed collection device or method (e.g. health
care provider collection: brush/spatula; self-collection:
tampon, etc.) and/or claimed liquid collection media
(specify brand), as appropriate (see note 2).
Performance may be compared by testing serial dilutions
of clinical HPV positive cervical specimens with a targeted
level of analyte.

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. Equivalence between specimen collection methods
may be established as part of clinical studies.
2. The specimen collection method may use different
specimen types, e.g. vaginal specimen collection
using a tampon, or cervical specimen collection using
a brush.
3. Paired specimens should be used.

Aspect

Testing requirements

Notes on testing requirements

Source Documents

1.2 Specimen storage and transport

1.2.1
Specimen
collection,
processing and
stability

Real time studies taking into account:
• storage conditions (duration at different
temperatures, temperature limits, freeze/thaw
cycles)
• transport conditions (see note 1)
• intended use (see note 1)
• specimen collection and/or transfer devices intended
to be used with the IVD (see 1.1.2)

1. Recommended storage conditions should be
established using a panel of real clinical cervical
specimens.
2. Evidence shall be provided which validates the
maximum allowable time between specimen
collection and its processing or addition to the IVD in
the setting where testing takes place.