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Discipline - Clinical microbiology
Bacterial culture
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory National reference laboratory
Assay format
Automated systems
Information History
First added in 2020
Changed in 2024
Purpose type
Diagnosis
Purpose
Initial step in the detection and identification of bacterial pathogens for selection of appropriate antibiotic regimens.
Specimen types
Urine, Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid), Respiratory specimens (e.g., Sputum, Bronchial brushing, Bronchoalveolar lavage), Exudates, Wound and abscess specimens, Genital specimens (e.g., Endocervical swabs, Urethral swabs, Vaginal swabs, Prostatic secretion), Corneal scrapings, Ear discharge, Catheter and device-related specimens, Tissue samples
WHO prequalified or recommended products
N/A
GMDN

61712

Microbial specimen inoculation/streaking/colony-picking instrument IVD

An electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.

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

W010401

BACTERIOLOGY - CULTURE MEDIA

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
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health. (2016). https://iris.who.int/bitstream/handle/10665/205490/9789241565028_eng.pdf?sequence=1 ; World Health Organization. (‎2025)‎. WHO guidelines on meningitis diagnosis, treatment and care. World Health Organization. https://iris.who.int/handle/10665/381006
Technical specifications
N/A
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A