Model List of Essential In-Vitro Diagnostics by World Health Organization

The World Health Organization (WHO) published the first edition of the Model List of Essential In Vitro Diagnostics (EDL) in May 2018. It is intended to complement the WHO Model List of Essential Medicines (EML).
Model List of Essential In Vitro Diagnostics (EDL) EDL will provide guidance and serve as a reference to Member States (including ministries of health, programme managers, end users such as laboratory managers, procurement officers and reimbursement systems), who are developing and/or updating lists of national essential IVDs for defining universal health coverage interventions, as well as selecting and implementing such IVDs.
The list concentrates on in vitro tests – i.e. tests of human specimens like blood and urine.
It contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients.

  1. General IVDs for primary health care
S. No.                                   Category                          Diagnostic Test
    1.                                 Hematology Hemoglobin (Hb)
 
    White blood cell Count
 
    CBC manual (only as back-up to automated method)
 
    2.         Clinical chemistry and immunoassays
 
Albumin
 
    Bilirubin
 
    Glucose
 
    Hemoglobin A1c (HbA1c)
 
    Whole blood lactate
 
    3.                                 Blood transfusion
 
Blood typing
 
   4.                                       Serology
 
Human chorionic gonadotropin (hCG)
 
   5.     Microbiology, Mycology and Parasitology
 
Urine dipstick and urine microscopy
 
    Microscopy
 

 

  1. Disease-specific IVDs for primary health care

 

S. No.                                   Category           Diagnostic Test
    1.                                   Hepatitis B
 
Hepatitis B surface antigen (HBsAg)
 
    Hepatitis B e antigen (HBeAg)
 
    2.                                    Hepatitis C
 
Antibodies to HCV
(anti-HCV)
   3.                                         HIV
                                    
Antibodies to HIV 1/2 (anti-HIV) test
 
    Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag) test
 
   4.                                      Malaria
 
Plasmodium spp. antigens; species specific (e.g. HRP2) and/or pan-species specific (e.g. pan-pLDH)
 
    Plasmodium spp.
 
    5.
 
 
                                Tuberculosis
 
Mycobacterium tuberculosis bacteria
 
    Immune response
 
    6.                                      Syphilis
 
Antibodies to Treponema pallidum
 
    Combined antibodies to T. pallidum and to HIV-1/2 (anti-HIV)
 

 
III. General IVDs for health care facilities with clinical laboratories
 

S. No.                                  Category Diagnostic Tests
    1.       Clinical chemistry and immunoassays
 
Alanine amino-transferase (ALT)
 
Albumin
 
Alkaline phosphatase
 
Aspartate amino- transaminase (AST)
 
Bilirubin
 
Blood pH and gases
 
Blood urea nitrogen  (BUN)
 
Creatinine
 
Electrolytes
 
Glucose
 
Haemoglobin A1c (HbA1c)
 
C-reactive protein (CRP)
 
    Lipid profile
 
Basic metabolic panel (BMP)
 
Comprehensive metabolic panel
 
Amylase and lipase
 
Troponin T/I
 
Urinalysis
 
      2.                             Blood transfusion
 
Blood cross-matching
 
Transfusion transmitted infections
 
      3.                                   Serology
 
Human chorionic gonadotropin (hCG)
 
      4.   Microbiology, mycology and parasitology
 
Urine dipstick and urine microscopy
 
  Culture
 
 
Blood culture
  Antimicrobial susceptibility testing
 
     5.                             Haematology
 
Haematocrit (Ht)
 
Prothrombin time test and international normalized ratio (PT/INR)
 
Platelet count
 
Complete blood count (CBC)
Automated, differential
  1. Disease-specific IVDs for health care facilities with clinical laboratories

 

S. NO.                                     Category       Diagnostic Tests
       1.                                   Hepatitis B
 
Hepatitis B surface antigen (HBsAg)
 
Virological
(HBV DNA – quantitative)
Hepatitis B e antigen (HBeAg)
 
IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc)
 
Antibodies to hepatitis B surface antigen (anti-HBs)
 
     2.                               Hepatitis C
 
Antibodies to HCV
(anti-HCV)
Antibodies to HCV (anti-HCV) and HCV core antigen (HCV cAg)
 
HCV core antigen
(HCV cAg)
HCV RNA (qualitative or quantitative)
 
      3.                                      HIV
 
Antibodies to HIV-1/2 (anti-HIV) test
 
Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag) test
 
HIV qualitative virological or quantitative virological
 
HIV quantitative virological
 
CD4 cell enumeration (quantitative)
 
Cryptococcal antigen test
 
      4.                                   Malaria
 
Plasmodium spp. antigens; species specific (e.g. HRP2) and/or pan-species specific (e.g. pan-pLDH)
 
Plasmodium spp.
 
Glucose-6-phosphate dehydrogenase activity (G6PD)
 
      5                            Tuberculosis
 
Mycobacterium tuberculosis bacteria
 
M. tuberculosis DNA
 
M. tuberculosis DNA mutations associated with resistance
 
M. tuberculosis culture-based DST
 
Lipoarabino- mannan (LAM) antigen
 
Immune response
 
      6.                                    HPV
 
Human papillomavirus (HPV) DNA
 
      7.                                  Syphilis
 
Antibodies to Treponema pallidum
 
Combined antibodies to T. pallidum and to HIV-1/2 (anti-HIV)
 

 
 Reference Links:

  1. https://www.healio.com/infectious-disease/practice management/news/online/%7Bce791df8-6a0b-4369-aaa d23699a7504b%7D/who-releases-first-essential-diagnostics-list.
  2. http://www.who.int/news-room/detail/15-05-2018-first-ever-who-list-of-essential-diagnostic-tests-to-improve-diagnosis-and-treatment-outcomes

 
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