1. ABO and RH
    ABO blood groups and Rhesus (Rh) factor typing
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  2. Albumin
    Albumin
    Kidney disease
    Setting
    Non-laboratory
    Assay format
    Dipstick
  3. 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
    Self-testing
  4. Antibodies to Treponema pallidum
    Antibodies to Treponema pallidum
    Syphilis, Sexually transmitted infections (STIs)
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  5. 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
    Self-testing
  6. 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
  7. CD4 cell enumeration
    Point-of-care flow cytometry
    CD4 cell enumeration
    HIV infection
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  8. 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
  9. 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
  10. 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
  11. Cryptococcal antigen
    Cryptococcal antigen
    HIV infection, Meningitis
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  12. Glucose
    Individual components: Glucose meter, test strips and associated calibrators and controls
    Glucose
    Diabetes mellitus
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
    Setting
    Non-laboratory
    Assay format
    Self-testing
  13. Glucose
    Glucose
    Diabetes mellitus, Meningitis
    Setting
    Non-laboratory
    Assay format
    Dipstick
  14. Glycated haemoglobin
    Glycated haemoglobin (HbA1c)
    Diabetes mellitus
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  15. Group A Streptococcus antigen
    Group A Streptococcus antigen
    Streptococcal pharyngitis
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  16. Haematocrit
    Haematocrit (Hct)
    Anaemia
    Setting
    Non-laboratory
    Assay format
    Microhaematocrit method
  17. Haemoglobin
    Individual components: Haemoglobinometer, test strips and associated controls
    Haemoglobin (Hb)
    Anaemia
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  18. Haemoglobin
    Haemoglobin (Hb)
    Anaemia
    Setting
    Non-laboratory
    Assay format
    Dipstick
  19. Haemoglobin A, S and C detection
    Haemoglobin A, S and C detection
    Sickle cell disease (SCD)
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  20. Hepatitis B surface antigen
    Hepatitis B surface antigen (HBsAg)
    Hepatitis B virus (HBV) infection
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  21. Human chorionic gonadotropin beta-subunit
    Human chorionic gonadotropin beta-subunit (beta-hCG)
    Cancer
    Setting
    Non-laboratory
    Assay format
    Dipstick
    Lateral flow RDT
  22. 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
  23. 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
  24. Ketones
    Ketones
    Setting
    Non-laboratory
    Assay format
    Dipstick
  25. Lead
    Anodic stripping voltammetry (ASV) point-of-care test
    Lead
    Lead exposure and poisoning
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  26. Lipoarabinomannan antigen
    Lipoarabinomannan (LAM) antigen
    HIV infection, Tuberculosis (TB)
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  27. 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
  28. Qualitative Glucose-6-phosphate dehydrogenase
    Qualitative Glucose-6-phosphate dehydrogenase (G6PD)
    Malaria
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  29. SARS-CoV-2 antigen
    SARS-CoV-2 antigen
    Coronavirus disease (COVID-19)
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  30. Semi-quantitative Glucose-6-phosphate dehydrogenase
    Semi-quantitative Glucose-6-phosphate dehydrogenase (G6PD)
    Malaria
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  31. Total cholesterol
    Total cholesterol
    Cardiovascular health
    Setting
    Non-laboratory
    Assay format
    Point-of-care test
  32. Trypanosoma cruzi IgG antibody
    Trypanosoma cruzi IgG antibody
    Chagas disease, Neglected tropical diseases
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
  33. Tuberculin skin test
    This is not an IVD test
    Tuberculin skin test (TST)
    Tuberculosis (TB)
    Setting
    Non-laboratory
    Assay format
    Mantoux test
  34. Urinalysis
    Individual analytes: Bilirubin, Blood, Glucose, Ketones, Leukocyte Esterase, Nitrites, pH, Protein, Specific Gravity, Urobilinogen
    Urinalysis
    Setting
    Non-laboratory
    Assay format
    Dipstick
  35. Vibrio cholerae antigen
    Vibrio cholerae antigen
    Cholera
    Setting
    Non-laboratory
    Assay format
    Lateral flow RDT
    Dipstick