MeDevIS eEDL MeDevPACKs

Fifth WHO Model List of

Essential In Vitro Diagnostics

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Setting

1. Non-laboratory (2)

2. Laboratory (11)

Type of test

Disease-specific (13)

General (0)

Disease/health condition

HIV infection (3)

Hepatitis B virus (HBV) infection (3)

Hepatitis C virus (HCV) infection (3)

Malaria (3)

Sexually transmitted infections (STIs) (1)

Syphilis (1)

Anaemia (0)

Arboviral diseases (0)

Aspergillosis (0)

Cancer (0)

Cardiovascular health (0)

Chagas disease (0)

Chlamydial infection (0)

Cholera (0)

Clostridioides difficile infection (0)

Coronavirus disease (COVID-19) (0)

Dengue (0)

Diabetes mellitus (0)

Endocrine disorders (0)

Gonorrhoea (0)

Hepatitis D virus (HDV) infection (0)

Hepatitis E virus (HEV) infection (0)

Influenza A and B infection (0)

Kidney disease (0)

Lead exposure and poisoning (0)

Leishmaniasis (0)

Leprosy (0)

Measles (0)

Meningitis (0)

Mpox infection (0)

Neglected tropical diseases (0)

Pertussis (Whooping cough) (0)

Pneumocystis pneumonia (0)

Primary immunodeficiency disorders (PIDs) (0)

Rubella (0)

Schistosomiasis (0)

Septicaemia (0)

Sickle cell disease (SCD) (0)

Sleeping sickness (0)

Soil-transmitted helminthiases (STH) (0)

Streptococcal pharyngitis (0)

Trypanosomiasis (0)

Tuberculosis (TB) (0)

Vaccine-preventable diseases (0)

Visceral leishmaniasis (Kala-azar) (0)

Zika virus infection (0)

Discipline

Anatomical pathology (0)

Clinical chemistry (0)

Clinical microbiology (0)

Coagulation (0)

Haematology (0)

Immunohematology (0)

Serology and Immunology (0)

Urinalysis (0)

Assay format

Immunoassay (8)

Particle agglutination (2)

Lateral flow RDT (2)

Microscopic examination (1)

Manual techniques (0)

Automated systems (0)

Optical methods on semi-automated or automated clinical chemistry analysers (0)

Immunoturbidimetry (0)

Ion-selective electrode (0)

Blood gas analyser (0)

Tube agglutination test (0)

Automated haematology analyser (0)

Point-of-care test (0)

Several formats involved (0)

Haemagglutination (0)

Coagulation analyser (0)

Microhaematocrit method (0)

Capillary electrophoresis (0)

NAAT (0)

Flow cytometry (0)

Latex agglutination immuneturbidimetry (0)

Radial immunodiffusion (RID) (0)

Charcoal agglutination (0)

Slide agglutination test (0)

Flocculation test (0)

Low-complexity manual NAAT (0)

Moderate-complexity automated NAAT (0)

Line probe assays (LPAs) (0)

High-complexity reverse hybridization NAAT (0)

Next-generation sequencing (NGS) (0)

ELISPOT assay (0)

Gel electrophoresis (0)

Dipstick (0)

Westergren (0)

Latex agglutination (0)

Self-testing (0)

Low-complexity automated NAAT (0)

Mantoux test (0)

Specimen type

Plasma (12)

Serum (12)

Capillary whole blood (3)

Venous whole blood (3)

Oral fluid (1)

Dried blood spots (DBS) (0)

Throat swab (0)

N/A (0)

Biopsy samples (0)

Cell block (0)

Surgical resection (0)

Fine needle aspiration (FNA) (0)

Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid) (0)

Body organs (e.g., Lymph node, Spleen, Cervix, Skin, etc) (0)

Bone marrow aspirate (0)

Respiratory specimens (e.g., Sputum, Bronchial brushing, Bronchoalveolar lavage) (0)

Formalin-Fixed, Paraffin-Embedded (FFPE) tissue blocks (0)

Exudates (0)

Bacterial isolates (0)

Slit-skin smear (0)

Sputum (0)

Cerebrospinal fluid (0)

Skin scrapings (0)

Hair (0)

Nail clippings or scrapings (0)

Vaginal discharge (0)

Oral swabs or scrapings (0)

Respiratory specimens (e.g., Sputum, Bronchial brushing) (0)

Corneal scrapings (0)

Ear discharge (0)

Fungal isolates (0)

Lymph node aspirate (0)

Wound and abscess specimens (0)

Urine (0)

Genital specimens (e.g., Endocervical swabs, Urethral swabs, Vaginal swabs, Prostatic secretion) (0)

Catheter and device-related specimens (0)

Tissue samples (0)

Arterial whole blood (0)

Peritoneal fluid (0)

Citrated plasma (0)

Bronchoalveolar lavage (0)

Bone marrow (0)

Liquid-based cervical cytology (0)

Oropharyngeal swab (0)

Stool (0)

Cervical cells collected in test-specific transport fluid/vials (0)

Genital specimens (e.g., Endocervical swabs, Urethral swabs, Vaginal swabs) (0)

Tracheal aspirate (0)

Nasopharyngeal aspirate (0)

Gastric aspirate (0)

Pleural tissue (0)

Pleural fluid (0)

Synovial fluid (0)

Pericardial fluid (0)

M. tuberculosis culture isolates (0)

Rectal swab (0)

Nasal wash (0)

Respiratory aspirate (0)

Lesion material (0)

Upper respiratory specimens (e.g., Nasal swab (0)

Nasopharyngeal swab (0)

Nasopharyngeal aspirate or wash) (0)

Tiered Testing Service

Regional or provincial hospital with laboratory (177)

District hospital with laboratory (155)

Primary health care center without laboratory (35)

WHO 2025 operational handbook on TB (19)

Blood establishment laboratory (13)

Community/outreach (10)

National reference laboratory (6)

N/A (3)

Year of recommendation

2018 (11)

2019 (0)

2020 (2)

2022 (0)

2024 (0)

Technical specifications available

No (7)

Yes (6)

WHO Model List of Essential In Vitro Diagnostics

Found 13 recommendations for 9 in vitro diagnostics

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Assay format Purpose type Purpose Specimen types Tiered testing service WHO prequalified or recommended products WHO supporting publications Technical specifications

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Antibodies to HIV 1/2

Antibodies to HIV 1/2 (anti-HIV 1/2)

HIV infection, Primary immunodeficiency disorders (PIDs)

Setting

Laboratory

Assay format

Immunoassay

Particle agglutination
Antibodies to Plasmodium spp.

Antibodies to Plasmodium spp.

Malaria

Setting

Laboratory

Assay format

Immunoassay
Antibodies to Treponema pallidum

Antibodies to Treponema pallidum

Syphilis, Sexually transmitted infections (STIs)

Setting

Laboratory

Assay format

Immunoassay
Antibodies to hepatitis C virus

Antibodies to hepatitis C virus (anti-HCV)

Hepatitis C virus (HCV) infection

Setting

Non-laboratory

Assay format

Lateral flow RDT

Setting

Laboratory

Assay format

Immunoassay
Combined antibodies to HCV and HCV core antigen

Combined antibodies to HCV and HCV core antigen

Hepatitis C virus (HCV) infection

Setting

Laboratory

Assay format

Immunoassay
Combined antibodies to HIV 1/2 - p24 antigen

Combined antibodies to HIV 1/2 - p24 antigen (anti-HIV 1/2 - p24 Ag)

HIV infection

Setting

Laboratory

Assay format

Immunoassay
Hepatitis B surface antigen

Hepatitis B surface antigen (HBsAg)

Hepatitis B virus (HBV) infection

Setting

Non-laboratory

Assay format

Lateral flow RDT

Setting

Laboratory

Assay format

Immunoassay

Particle agglutination
Plasmodium spp.
Stains: Giemsa or Wright-Giemsa

Plasmodium spp.

Malaria

Setting

Laboratory

Assay format

Microscopic examination
Plasmodium spp. antigens
Plasmodium spp. antigens: species-specific (PfHRP2, pLDH) or pan-malarial antigens (Pan-pLDH or aldolase)

Plasmodium spp. antigens

Malaria

Setting

Laboratory

Assay format

Immunoassay