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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