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Disease/health condition - Cancer
Papanicolaou (Pap) stain
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Microscopic examination
Information History
First added in 2019
Changed in 2024
Purpose type
Screening, Aid to diagnosis
Purpose
To screen for and to aid in early diagnosis of cervical cancer.
Specimen types
Liquid-based cervical cytology
WHO prequalified or recommended products
N/A
GMDN

65667

Endocervical specimen cytological examination kit IVD

A collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. This is a single-use device.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W01030708

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2013)‎. WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. World Health Organization. https://iris.who.int/handle/10665/94830
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion of the Pap smear test on the EDL, noting that the test is already widely used and is an effective alternative to HPV screening. Recommended test purpose: for screening and as an aid in early diagnosis of cervical cancer.
There is strong evidence for the accuracy of Pap smear testing and the impact of screening programmes with this test on mortality and advanced cancer rates. It is unclear whether Pap smear testing can be used to triage women with HPV infection.
The Group was aware of substantial evidence of reductions in cervical cancer mortality in countries in which Pap smear testing has been used. The Group also noted emerging evidence of the greater benefits of screening with HPV testing than with the Pap smear (8) but recognized that HPV testing may not be feasible in all settings.
World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527