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Disease/health condition -
Vaccine-preventable diseases, Pertussis (Whooping cough)
Bordetella pertussis nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of whooping cough in the early stages of the disease (in the first three weeks of cough onset).
Specimen types
Nasal wash, Nasopharyngeal swab, Bronchoalveolar lavage, Respiratory aspirate, Sputum
WHO prequalified or recommended products
N/A
GMDN
50513
Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Bordetella pertussis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
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 2005-2024EMDN
W0105011607
BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
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/emdnWHO supporting publications
World Health Organization. (2014). Laboratory Manual for the diagnosis of whooping cough caused by bordetella pertussis/bordetella parapertussis : update 2014. World Health Organization. https://iris.who.int/handle/10665/127891 ; World Health Organization. Pertussis: Vaccine Preventable Diseases Surveillance Standards.* . Available at: https://cdn.who.int/media/docs/default-source/immunization/vpd_surveillance/vpd-surveillance-standards-publication/who-surveillancevaccinepreventable-16-pertussis-r2.pdf?sfvrsn=a0157ae7_10&download=true
* Internet
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended conditionally listing the Bordetella pertussis test in EDL 5:
• as a disease-specific IVD for use in health care facilities with clinical laboratories (Section II.b. Vaccine-preventable diseases);
• using NAAT as assay format;
• using nasal wash, nasopharyngeal swabs, bronchoalveolar lavage, respiratory aspirates, or sputum as specimen type;
• to aid in the diagnosis of whooping cough in the early stages of the disease (in the first three weeks of cough onset).
• as a disease-specific IVD for use in health care facilities with clinical laboratories (Section II.b. Vaccine-preventable diseases);
• using NAAT as assay format;
• using nasal wash, nasopharyngeal swabs, bronchoalveolar lavage, respiratory aspirates, or sputum as specimen type;
• to aid in the diagnosis of whooping cough in the early stages of the disease (in the first three weeks of cough onset).
The application proposed the inclusion of a nucleic acid amplification test for Bordetella pertussis. It was noted that B. pertussis, the cause of whooping cough, is vaccine-preventable disease but increasing due to: inadequate vaccination in children; antigenic variation reducing vaccine effectiveness; and rising prevalence in adults. Molecular tests are essential for rapid detection, especially given the limitations of culture sensitivity and delays in serological methods.
The SAGE IVD recognized the test was a potentially important public health tool, particularly for outbreaks and surveillance and that molecular assays had higher sensitivity than traditional methods (culture). The proposed test can be performed using open systems and across multiple real-time PCR machines. Some concerns were raised about insufficient data on test specificity across kits; sample processing, storage and handling; and affordability and accessibility, especially in LMICs. It was seen as more useful for monitoring vaccination programme effectiveness than for individual case management.
Views were mixed on whether to conditionally list, fully list or reject the application for now, but the majority supported conditional listing with the requirement for additional data submission, specifically on cost, specificity and operational feasibility, particularly for LMICs.
No systematic review evidence on diagnostic performance was provided by the applicant. Primary studies are methodologically flawed, though the general trend remains that PCR and particularly RT-PCR, have excellent diagnostic accuracy for detecting pertussis. Even when alternative reference standards (such as CRS and LCA) are used, diagnostic accuracy was still found to be very high.
No systematic reviews or primary studies on clinical utility were provided by the applicant.
Regarding cost-effectiveness analysis, only one cost of illness study is provided, which does not address RT-PCR specifically. As such there is insufficient evidence on cost-effectiveness of RT-PCR.
Though studies on diagnostic accuracy are methodologically flawed, their extremely high estimates and limited uncertainty surrounding the point estimates (i.e. large sample size) make it likely that this test is able to differentiate those with and without Bordetella. Downstream consequences on clinical utility and cost-effectiveness are unknown, and depend greatly on clinical consequences, and availability and effectiveness of treatment.
The selection and use of essential in vitro diagnostics: report of the fifth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2024. World Health Organization. (To be published)