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.
- General IVDs for primary health care
| S. No. | Category | Diagnostic Test |
| 1. | Hematology | Hemoglobin (Hb)
|
| White blood cell Count
|
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| CBC manual (only as back-up to automated method)
|
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| 2. | Clinical chemistry and immunoassays
|
Albumin
|
| Bilirubin
|
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| Glucose
|
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| Hemoglobin A1c (HbA1c)
|
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| Whole blood lactate
|
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| 3. | Blood transfusion
|
Blood typing
|
| 4. | Serology
|
Human chorionic gonadotropin (hCG)
|
| 5. | Microbiology, Mycology and Parasitology
|
Urine dipstick and urine microscopy
|
| Microscopy
|
- 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.
|
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| 5.
|
Tuberculosis
|
Mycobacterium tuberculosis bacteria
|
| Immune response
|
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| 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)
|
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| Albumin
|
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| Alkaline phosphatase
|
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| Aspartate amino- transaminase (AST)
|
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| Bilirubin
|
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| Blood pH and gases
|
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| Blood urea nitrogen (BUN)
|
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| Creatinine
|
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| Electrolytes
|
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| Glucose
|
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| Haemoglobin A1c (HbA1c)
|
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| C-reactive protein (CRP)
|
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| Lipid profile
|
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| Basic metabolic panel (BMP)
|
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| Comprehensive metabolic panel
|
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| Amylase and lipase
|
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| Troponin T/I
|
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| Urinalysis
|
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| 2. | Blood transfusion
|
Blood cross-matching
|
||
| Transfusion transmitted infections
|
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| 3. | Serology
|
Human chorionic gonadotropin (hCG)
|
||
| 4. | Microbiology, mycology and parasitology
|
Urine dipstick and urine microscopy
|
||
| Culture
|
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|
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| Antimicrobial susceptibility testing
|
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| 5. | Haematology
|
Haematocrit (Ht)
|
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| Prothrombin time test and international normalized ratio (PT/INR)
|
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| Platelet count
|
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| Complete blood count (CBC)
Automated, differential |
- 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
|
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| 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:
- https://www.healio.com/infectious-disease/practice management/news/online/%7Bce791df8-6a0b-4369-aaa d23699a7504b%7D/who-releases-first-essential-diagnostics-list.
- 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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