MeDevIS eEDL MeDevPACKs

Fifth WHO Model List of

Essential In Vitro Diagnostics

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Setting

1. Non-laboratory (34)

2. Laboratory (1)

Type of test

Disease-specific (29)

General (9)

Disease/health condition

HIV infection (5)

Diabetes mellitus (3)

Malaria (3)

Anaemia (2)

Cholera (2)

Kidney disease (2)

Neglected tropical diseases (2)

Sexually transmitted infections (STIs) (2)

Sickle cell disease (SCD) (2)

Syphilis (2)

Cardiovascular health (1)

Chagas disease (1)

Coronavirus disease (COVID-19) (1)

Hepatitis B virus (HBV) infection (1)

Hepatitis C virus (HCV) infection (1)

Hepatitis E virus (HEV) infection (1)

Lead exposure and poisoning (1)

Meningitis (1)

Primary immunodeficiency disorders (PIDs) (1)

Streptococcal pharyngitis (1)

Visceral leishmaniasis (Kala-azar) (1)

Arboviral diseases (0)

Aspergillosis (0)

Cancer (0)

Chlamydial infection (0)

Clostridioides difficile infection (0)

Dengue (0)

Endocrine disorders (0)

Gonorrhoea (0)

Hepatitis D virus (HDV) infection (0)

Influenza A and B infection (0)

Leishmaniasis (0)

Leprosy (0)

Measles (0)

Mpox infection (0)

Pertussis (Whooping cough) (0)

Pneumocystis pneumonia (0)

Rubella (0)

Schistosomiasis (0)

Septicaemia (0)

Sleeping sickness (0)

Soil-transmitted helminthiases (STH) (0)

Trypanosomiasis (0)

Tuberculosis (TB) (0)

Vaccine-preventable diseases (0)

Zika virus infection (0)

Discipline

Anatomical pathology (0)

Clinical chemistry (1)

Clinical microbiology (0)

Coagulation (0)

Haematology (2)

Immunohematology (1)

Serology and Immunology (2)

Urinalysis (3)

Assay format

Lateral flow RDT (17)

Point-of-care test (9)

Dipstick (7)

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)

Westergren (0)

Latex agglutination (0)

Self-testing (0)

Low-complexity automated NAAT (0)

Mantoux test (0)

Specimen type

Capillary whole blood (23)

Venous whole blood (9)

Urine (7)

Plasma (4)

Serum (4)

Oral fluid (2)

Stool (2)

Rectal swab (2)

Throat swab (1)

Upper respiratory specimens (e.g., Nasal swab (1)

Nasopharyngeal swab (1)

Nasopharyngeal aspirate or wash) (1)

Dried blood spots (DBS) (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)

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)

Nasal wash (0)

Respiratory aspirate (0)

Lesion material (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 (16)

2019 (5)

2020 (8)

2022 (2)

2024 (4)

Technical specifications available

No (28)

Yes (7)

WHO Model List of Essential In Vitro Diagnostics

Found 35 recommendations for 33 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
Albumin

Albumin

Kidney disease

Setting

Non-laboratory

Assay format

Dipstick
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
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
Antibodies to recombinant K39 antigen

Antibodies to recombinant K39 (rK39) antigen

Neglected tropical diseases, Visceral leishmaniasis (Kala-azar)

Setting

Non-laboratory

Assay format

Lateral flow RDT
CD4 cell enumeration
Point-of-care flow cytometry

CD4 cell enumeration

HIV infection

Setting

Non-laboratory

Assay format

Point-of-care test
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

Non-laboratory

Assay format

Lateral flow RDT
Combined antibodies to Treponema pallidum and HIV 1/2

Combined antibodies to Treponema pallidum and HIV 1/2

HIV infection, 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
Cryptococcal antigen

Cryptococcal antigen

HIV infection, Meningitis

Setting

Non-laboratory

Assay format

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

Glucose

Diabetes mellitus

Setting

Non-laboratory

Assay format

Point-of-care test
Glucose

Glucose

Diabetes mellitus, Meningitis

Setting

Non-laboratory

Assay format

Dipstick
Glycated haemoglobin

Glycated haemoglobin (HbA1c)

Diabetes mellitus

Setting

Non-laboratory

Assay format

Point-of-care test
Group A Streptococcus antigen

Group A Streptococcus antigen

Streptococcal pharyngitis

Setting

Non-laboratory

Assay format

Lateral flow RDT
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
Haemoglobin

Haemoglobin (Hb)

Anaemia

Setting

Non-laboratory

Assay format

Dipstick
Haemoglobin A, S and C detection

Haemoglobin A, S and C detection

Sickle cell disease (SCD)

Setting

Non-laboratory

Assay format

Lateral flow RDT
Hepatitis B surface antigen

Hepatitis B surface antigen (HBsAg)

Hepatitis B virus (HBV) infection

Setting

Non-laboratory

Assay format

Lateral flow RDT
Human chorionic gonadotropin beta-subunit

Human chorionic gonadotropin beta-subunit (beta-hCG)

Cancer

Setting

Non-laboratory

Assay format

Dipstick

Lateral flow RDT
IgM antibodies to hepatitis E virus

IgM antibodies to hepatitis E virus (anti-HEV IgM)

Hepatitis E virus (HEV) infection

Setting

Non-laboratory

Assay format

Lateral flow RDT
Ketones

Ketones

Setting

Non-laboratory

Assay format

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

Lead

Lead exposure and poisoning

Setting

Non-laboratory

Assay format

Point-of-care test
Plasmodium spp. antigens
Plasmodium spp. antigens: species-specific (PfHRP2, pLDH) or pan-malarial antigens (Pan-pLDH or aldolase)

Plasmodium spp. antigens

Malaria

Setting

Non-laboratory

Assay format

Lateral flow RDT
Qualitative Glucose-6-phosphate dehydrogenase

Qualitative Glucose-6-phosphate dehydrogenase (G6PD)

Malaria

Setting

Non-laboratory

Assay format

Lateral flow RDT
SARS-CoV-2 antigen

SARS-CoV-2 antigen

Coronavirus disease (COVID-19)

Setting

Non-laboratory

Assay format

Lateral flow RDT
Semi-quantitative Glucose-6-phosphate dehydrogenase

Semi-quantitative Glucose-6-phosphate dehydrogenase (G6PD)

Malaria

Setting

Non-laboratory

Assay format

Point-of-care test
Sodium metabisulfite slide test
Also known as Emmel’s sickling test

Sodium metabisulfite slide test

Sickle cell disease (SCD)

Setting

Laboratory

Assay format

Microscopic examination
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
Urinalysis
Individual analytes: Bilirubin, Blood, Glucose, Ketones, Leukocyte Esterase, Nitrites, pH, Protein, Specific Gravity, Urobilinogen

Urinalysis

Setting

Non-laboratory

Assay format

Dipstick
Vibrio cholerae antigen

Vibrio cholerae antigen

Cholera

Setting

Non-laboratory

Assay format

Lateral flow RDT

Dipstick