MeDevIS eEDL MeDevPACKs

Fifth WHO Model List of

Essential In Vitro Diagnostics

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Setting

1. Non-laboratory (10)

2. Laboratory (0)

Type of test

Disease-specific (9)

General (3)

Disease/health condition

Anaemia (2)

Neglected tropical diseases (2)

Cardiovascular health (1)

Chagas disease (1)

HIV infection (1)

Kidney disease (1)

Lead exposure and poisoning (1)

Primary immunodeficiency disorders (PIDs) (1)

Schistosomiasis (1)

Sexually transmitted infections (STIs) (1)

Soil-transmitted helminthiases (STH) (1)

Syphilis (1)

Arboviral diseases (0)

Aspergillosis (0)

Cancer (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 B virus (HBV) infection (0)

Hepatitis C virus (HCV) infection (0)

Hepatitis D virus (HDV) infection (0)

Hepatitis E virus (HEV) infection (0)

Influenza A and B infection (0)

Leishmaniasis (0)

Leprosy (0)

Malaria (0)

Measles (0)

Meningitis (0)

Mpox infection (0)

Pertussis (Whooping cough) (0)

Pneumocystis pneumonia (0)

Rubella (0)

Septicaemia (0)

Sickle cell disease (SCD) (0)

Sleeping sickness (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 (2)

Immunohematology (1)

Serology and Immunology (0)

Urinalysis (0)

Assay format

Point-of-care test (5)

Lateral flow RDT (3)

Microscopic examination (1)

Microhaematocrit method (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)

Immunoassay (0)

Tube agglutination test (0)

Automated haematology analyser (0)

Several formats involved (0)

Haemagglutination (0)

Coagulation analyser (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)

Particle agglutination (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

Capillary whole blood (9)

Venous whole blood (2)

Plasma (1)

Oral fluid (1)

Stool (1)

Serum (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)

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 (2)

2019 (2)

2020 (2)

2022 (1)

2024 (3)

Technical specifications available

No (9)

Yes (1)

WHO Model List of Essential In Vitro Diagnostics

Found 10 recommendations for 10 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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ABO and RH

ABO blood groups and Rhesus (Rh) factor typing

Setting

Non-laboratory

Assay format

Point-of-care test
Antibodies to HIV 1/2

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

HIV infection, Primary immunodeficiency disorders (PIDs)

Setting

Non-laboratory

Assay format

Lateral flow RDT
Antibodies to Treponema pallidum

Antibodies to Treponema pallidum

Syphilis, Sexually transmitted infections (STIs)

Setting

Non-laboratory

Assay format

Lateral flow RDT
Creatinine
Individual components: Creatinine portable meter, test strips and associated calibrators and controls

Creatinine

Kidney disease

Setting

Non-laboratory

Assay format

Point-of-care test
Haematocrit

Haematocrit (Hct)

Anaemia

Setting

Non-laboratory

Assay format

Microhaematocrit method
Haemoglobin
Individual components: Haemoglobinometer, test strips and associated controls

Haemoglobin (Hb)

Anaemia

Setting

Non-laboratory

Assay format

Point-of-care test
Kato-Katz faecal smear
STH: Ascaris lumbricoides, Trichuris trichiura, Necator americanus and Ancylostoma duodenale. Schistosoma mansoni, S. japonicum, S. intercalatum, and S. mekongi.

Kato-Katz faecal smear

Neglected tropical diseases, Soil-transmitted helminthiases (STH), Schistosomiasis

Setting

Non-laboratory

Assay format

Microscopic examination
Lead
Anodic stripping voltammetry (ASV) point-of-care test

Lead

Lead exposure and poisoning

Setting

Non-laboratory

Assay format

Point-of-care test
Total cholesterol

Total cholesterol

Cardiovascular health

Setting

Non-laboratory

Assay format

Point-of-care test
Trypanosoma cruzi IgG antibody

Trypanosoma cruzi IgG antibody

Chagas disease, Neglected tropical diseases

Setting

Non-laboratory

Assay format

Lateral flow RDT