MEDEVIS

Rapid diagnostic test (RDT) (dipstick and cassette), latex agglutination (1)

Microscopic examination; May require staining procedures for microbial pathogens (e.g. Gram stain, modified Ziehl–Neelsen stain) (0)

Microscopic examination; May require staining procedures for microbial pathogens and cytological examination for neoplastic cells (0)

IHC testing (ki-67, CD45, BCL6, IRF4/MUM1, MYC, CD20, CD5, CD10, BCL2, CD23, CD79a, cyclinD1, CD3, CD15, CD30, TdT, CD138/syndecan-1, kappa and lambda chains, PAX5) (0)

IHC testing markers include desmin, cytokeratin, AE1/AE3, S100, synaptophysin, myogenin, hCG, PLAP, Oct3/4, NANOG, CD30, CD117/c-kit, WT1, SALL4 (0)

Flow cytometry (CD10, CD19, CD45, CD34, CD7, CD33, CD117, myeloperoxidase, CD79a, cytoplasmic CD3, HLA-DR, CD5, CD23, CD43) (0)

Immunoassay or enzyme-linked immune absorbent spot (ELISpot) assay (0)

Macroscopic assessment of tissue and selection of areas for microscopic examination; Microscopy of tissue sections mounted on slides and stained most commonly with haematoxylin and eosin in the first instance, then treated with a variety of special stains, selected case by case to identify pathogens and other abnormal features (0)

Microscopy of histopathology tissue sections mounted on slides and stained with antibodies to specific markers ; Refer to EDL sections on disease-specific tests for individual assays (0)

Macroscopic assessment and microscopy of tissue sections; Procedures selected case by case (0)

Microscopic examination of slides which may use different types of microscopes and stains (0)

Culture on growth media plates or broth in an incubator followed by recovery of isolates and species identification (traditional manual techniques or automated equipment) (0)

Blood culture bottle in an incubator followed by recovery of isolates (traditional manual techniques or automated equipment) (0)

Antimicrobial susceptibility testing of isolates may be done manually (by disc diffusion, gradient tests and broth microdilution), or by automated platforms (0)

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

Optical methods on semi-automated or automated chemistry analysers methods; automated chemistry analyser if available (0)

Blood gas analysers, including portable analysers for emergency and critical care (0)

Electrochemical or optical methods on semi-automated or automated chemistry analysers (0)

Electrochemical or optical methods on semi-automated or automated chemistry analyser (0)

Optical and electrochemical methods on semi-automated or automated chemistry analysers and handheld analysers. (0)

Automated haematology analyser, total and differential counts of WBCs, RBCs, platelets, Hb and haematocrit (Hct) (0)

Haemocytometer / automated haematology analysers with body fluid mode (0)

Wright–Giemsa-stained smears /automated haematology analysers with body fluid mode (0)

Hand-held or automated coagulation analyser (fibrinogen activity); Immunoassay (fibrinogen antigen) (0)

Micro-haematocrit method (if automated haematology analyser not available) (0)

Optical methods, haemoglobinometer, if automated haematology analyser not available (0)

Optical methods (iron and TIBC); Immunoassay (ferritin and transferrin) (0)

Haemocytometer, if automated haematology analyser is not available (0)

Haemocytometer, if automated haematology analyser not available (0)

Rapid diagnostic test (RDT) (dipstick and cassette), latex agglutination

Instrument-based point-of-care immunoassay

RDT; Handheld or small benchtop instrument for POC use

WHO Model List of

Essential In Vitro Diagnostics

WHO Model List of Essential In Vitro Diagnostics

Export

ABO and RH

ABO and RH

Albumin

Bilirubin

CD4 cell enumeration

Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag)

Combined antibodies to T. pallidum and HIV-1/2

Cryptococcal antigen

Erythrocyte sedimentation rate (ESR)

Glucose

Group A Streptococcus antigen

HIV 1/2 antibody (anti-HIV Ab)

HIV qualitative nucleic acid test

Haemoglobin (Hb)

Haemoglobin A1c (HbA1c)

Hepatitis B e antigen (HBeAg)

Hepatitis B surface antigen (HBsAg)

Hepatitis C antibody (Anti-HCV Ab)

Human chorionic gonadotropin (hCG)
Pregnacy testing; Tumor marker

Influenza A and B antigen

Influenza A and B nucleic acid

Ketones

Lipoarabinomannan (LAM) antigen

Plasmodium spp. antigens
species-specific (e.g. HRP2) and/ or pan-species specific (e.g. pan-pLDH)

SARS CoV-2 antigen

Sickle cell testing

Treponema pallidum antibodies

Trypanosoma cruzi IgG antibody

Tuberculin skin (Mantoux) test (TST)

Urinalysis test strips

Vibrio cholerae antigen

Anti-HEV IgM

RK39 antigen

WHO Model List of Essential In Vitro Diagnostics

Export

ABO and RH

ABO and RH

Albumin

Bilirubin

CD4 cell enumeration

Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag)

Combined antibodies to T. pallidum and HIV-1/2

Cryptococcal antigen

Erythrocyte sedimentation rate (ESR)

Glucose

Group A Streptococcus antigen

HIV 1/2 antibody (anti-HIV Ab)

HIV qualitative nucleic acid test

Haemoglobin (Hb)

Haemoglobin A1c (HbA1c)

Hepatitis B e antigen (HBeAg)

Hepatitis B surface antigen (HBsAg)

Hepatitis C antibody (Anti-HCV Ab)

Human chorionic gonadotropin (hCG) Pregnacy testing; Tumor marker

Influenza A and B antigen

Influenza A and B nucleic acid

Ketones

Lipoarabinomannan (LAM) antigen

Plasmodium spp. antigens species-specific (e.g. HRP2) and/ or pan-species specific (e.g. pan-pLDH)

SARS CoV-2 antigen

Sickle cell testing

Treponema pallidum antibodies

Trypanosoma cruzi IgG antibody

Tuberculin skin (Mantoux) test (TST)

Urinalysis test strips

Vibrio cholerae antigen

Anti-HEV IgM

RK39 antigen

Human chorionic gonadotropin (hCG)
Pregnacy testing; Tumor marker

Plasmodium spp. antigens
species-specific (e.g. HRP2) and/ or pan-species specific (e.g. pan-pLDH)