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Laboratory tests for diagnosis and monitoring1
Primary care level2 District level3 Regional or referral level4
Nationallevel5
Send out6 Performon-site Send out6 Perform
on-site Send out6 Performon-site
Performon-site
HIV antibody testing
Lab ELISA a a a a
Rapid point of care 1 a a a a
Rapid point of care 2 a a a a
Rapid point of care 3 a
HIV virological diagnostic testing
RNA a a a a
DNA a a a a
Ultrasensitive p24 antigen a a a a
HIV viral load measurement a a a
Haemoglobin
Haemoglobinometer such as HemoCue a a a a
WHO colour scale a a a
Full blood count and differential a a a a
CD4
Absolute count a a a a a
% a a a a a
HIV resistance testing7 a8
Pregnancy testing
Urine rapid test ?9 a a a
Liver function tests (transaminases and bilirubin) a a a
Glucose
Blood dipstick a a a
Urine dipstick a a a a
Blood a a a
Serum electrolytes ? a a a
Renal function tests (creatinine /urea) a a a
Urine protein dipstick a a a a
Lipids a a
Amylase a a a
Lactate a a a
Oxygen saturation – pulse oximetry a a a
Blood gases Ph a a
1. These are the generic recommendations and it is recognized that exceptions apply (e.g., some health centers will send out some tests). Where appropriate these tests may used for public health surveillance and quality assurance activities.
2. Primary health care services are those providing first point of contact with the health care system.3. District level is defined as hospital at the first referral level that is responsible for a district of a defined
geographical area containing a defined population and governed by a politico-administrative organization such as a district health management team.
4. In some smaller countries there may not be regional laboratories.5. Including the national reference laboratory or public health laboratory, which is usually responsible for quality
assurance and surveillance activities.6. “Send out” refers to not having the testing capability on site and samples or patients are sent to another site for
the actual test to be performed.
7. HIV DR testing is only recommended as part of national efforts for surveillance and monitoring as outlined in WHO HIV DR strategy and is usually done by sending out to an accredited international lab.
8. May be done at national level or sent to accredited lab.9. May need to reconsider recommendation at primary care level. WHO ART guidelines recommend in context of efavirenz initiation. Pregnancy test not recommended for routine pregnancy care at the primary level. Most women seek antenatal
care when pregnancy is “obvious” and the pregnancy test does not add additional information.
SUMMARY OF WHO RECOMMENDATIONS ON LABORATORY INVESTIGATIONS FOR CLINICAL CARE BY LEVEL OF HEALTH CARE FACILITY
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HIV/AIDS Department
1. These are the generic recommendations and it is recognized that exceptions apply (e.g., some health centers will send out some tests). Where appropriate these tests may used for public health surveillance and quality assurance activities.
2. Primary health care services are those providing first point of contact with the health care system.3. District level is defined as hospital at the first referral level that is responsible for a district of a defined
geographical area containing a defined population and governed by a politico-administrative organization such as a district health management team.
4. In some smaller countries there may not be regional laboratories.5. Including the national reference laboratory or public health laboratory, which is usually responsible for quality
assurance and surveillance activities.6. “Send out” refers to not having the testing capability on site and samples or patients are sent to another site for
the actual test to be performed.
10. At some health centres depending on specimen load.11. Given complexity of using DSTs may need adaptation.12. Provision guided by Hepatitis C prevalence.13. High prevalence, low IDU and for surveillance.
Diagnostic tests for treatable co-infections and major HIV-related opportunistic diseases
Laboratory tests for diagnosis and monitoring1
Primary care level2 District level3 Regional orreferral level4
Nationallevel5
Send out6 Performon-site Send out6 Perform
on-site Send out6 Performon-site
Performon-site
Tuberculosis
Microscopy
Light a a a10 a a
Fluorescence a a a
Culture
Solid medium a a ?10 a a
Liquid medium a a a a
Drug susceptibility test 11
First-line a a a
Second-line a a a
Diagnosis of malaria
Rapid test for malaria a a a a
Microscopy for malaria (thick/thin) a a a a
Cerebrospinal fluid (CSF)
Basic CSF microscopy including India ink and Gram stain and Ziehl-Neelsen a a a
CSF culture a a a
CSF glucose a a a
Cryptococcal antigen (serum or CSF ) a a a
STI diagnostic tests
Microscopy (Gram & wet) a a a
Gonorrhea a a a
Chlamidya a a a
Syphilis rapid diagnostic test a a a a
Syphilis serological (RPR, FTA and TPHA) a a a
Hepatitis B a a a a
Hepatitis C12 a a a13
PCP a
Blood culture a a a
Radiography a a a
HIV/AIDS Department
SUMMARY OF WHO RECOMMENDATIONS ON LABORATORY INVESTIGATIONS FOR CLINICAL CARE BY LEVEL OF HEALTH CARE FACILITY
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HIV/AIDS Department
SUMMARY OF WHO RECOMMENDATIONS ON LABORATORY INVESTIGATIONS FOR CLINICAL CARE BY LEVEL OF HEALTH CARE FACILITY
WHO consultation on technical and operational recommendations for scale-up of laboratory services and monitoring HIV antiretroviral therapy in resource-limited settingshttp://www.who.int/hiv/pub/meetingreports/scaleup/en/index.html
Standards for quality HIV care: a tool for quality assessment, improvement, and accreditationhttp://www.who.int/hiv/pub/prev_care/en/standardsquality.pdf
Guidance on provider-initiated HIV testing and counselling in health facilitieshttp://whqlibdoc.who.int/publications/2007/9789241595568_eng.pdf
Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approachhttp://www.who.int/hiv/pub/guidelines/artadultguidelines.pdf
Antiretroviral therapy for HIV infection in infants and children: towards universal access. Recommendations for a public health approachhttp://www.who.int/hiv/pub/guidelines/paediatric020907.pdf
Antiretroviral drugs antiretroviral for treating pregnant women and preventing hiv infection in infants: towards universal access. Recommendations for a public health approachhttp://www.who.int/hiv/pub/guidelines/pmtctguidelines3.pdf
IMAI Sharepointhttp://www.who.int/hiv/capacity/IMAIsharepoint/en/ Contact: [email protected]://www.who.int/hiv/capacity/Access_Sharepoint.pdf (registration required)
CD4+ T-cell enumeration technologieshttp://www.who.int/diagnostics_laboratory/CD4_Technical_Advice_ENG.pdf
Early detection of HIV infection in infants and children. Technical guidance notehttp://www.who.int/hiv/paediatric/EarlydiagnostictestingforHIVVer_Final_May07.pdf
WHO case definitions of HIV for surveillance and revised clinical staging and immunological classification of HIV-related disease in adults and childrenhttp://www.who.int/hiv/pub/guidelines/HIVstaging150307.pdf
Guidelines for appropriate evaluations of HIV testing technologies in Africahttp://www.who.int/diagnostics_laboratory/publications/EN_HIVEval_Guide.pdf
Essential list of laboratory equipment and supplies for HIV testinghttp://www.afro.who.int/aids/laboratory_services/resources/list-laboratory.pdf
Rapid HIV tests: guidelines for use in HIV testing and counselling services in resource-constrained settingshttp://whqlibdoc.who.int/publications/2004/9241591811.pdf
Joint United Nations Programme on HIV/AIDS (UNAIDS) – WHO revised recommendations for the selection and use of HIV antibody testshttp://www.who.int/diagnostics_laboratory/publications/en/Selection_HIV_tests.pdf
HIV assays: operational characteristics (phase 1) report 14 simple/rapid testshttp://www.who.int/diagnostics_laboratory/publications/hiv_assays_rep_14.pdf
HIV assays: operational characteristics (phase 1) report 15 antigen/antibody elisashttp://www.who.int/diagnostics_laboratory/publications/en/HIV_Report15.pdf
Guidelines for organizing national external quality assessment schemes for HIV serological testinghttp://www.who.int/diagnostics_laboratory/quality/en/EQAS96.pdf
Guidelines or assuring the accuracy and reliability of HIV rapid testing: Applying a quality system approachhttp://www.who.int/diagnostics_laboratory/publications/HIVRapidsGuide.pdf
Chapter 2: Overview of current TB diagnostics http://www.who.int/tdr/publications/publications/pdf/tbdi/tbdi_chap2.pdf
Chapter 5 : Potential market for new TB diagnosticshttp://www.who.int/tdr/publications/publications/pdf/tbdi/tbdi_chap5.pdf
The use of malaria rapid diagnostic testshttp://www.who.int/tdr/diseases/malaria/files/wpro_guidelines.pdf
The use of rapid syphilis testshttp://www.who.int/std_diagnostics/publications/manuals/Syphilis_Eng_14May07.pdf
Integrated management of pregnancy and childbirth. Pregnancy, childbirth, postpartum and newborn care: A guide for essential practiceFor primary level: http://www.who.int/making_pregnancy_safer/publications/PCPNC_2006_03b.pdf
Integrated management of pregnancy and childbirth. Managing complications in pregnancy and childbirth: A guide for midwives and doctorsFor referral level:http://www.who.int/making_pregnancy_safer/publications/archived_publications/mcpc.pdf
Laboratory services at the district levelhttp://www.who.int/eht/en/Laboratory.pdf
Equipment requirements for a PHC centre laboratoryhttp://www.phclab.com/images/PHC.pdf
Global recommendations and guidelines: Task shiftinghttp://www.who.int/healthsystems/TTR_TaskShifting.pdf
References:
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