2.0: National HIV Reference Laboratory

2.0: National HIV Reference Laboratory 2.1: Introduction The National HIV Reference Laboratory (NHRL) is ISO 15189 accredited. Its broad mandate is to offer specialized testing on HIV and strengthen laboratory systems in Quality Assurance (QA) activities in support of HIV prevention, care, treatment and surveillance in the country. Its roles include;

 Specialized HIV testing  Development of guidelines, tools and standard operating procedures  Technical support to the Counties to review laboratory infrastructural preparedness  Forecasting and quantification of commodities, supplies and reagents  External quality assessments within testing laboratories  Technical progress reviews through technical working groups  Support of laboratory accreditation efforts within the testing laboratories

The lab comprises of 3 sections namely Molecular, Serology and CD4 Monitoring 2.2: NHRL Test Menu The molecular section undertakes the following:

 Performs Early Infant Diagnosis (EID) viral load testing.  Co-ordination and provision of laboratory technical support in policy and guidelines formulation on EID and viral load testing in the country  In the near future, the section plans to introduce HIV drug resistance testing to confirm ART treatment failure. The Serology section undertakes the following:

 Confirmation of discrepant results from the field and discordant couple’s results using ELISA.  Provides HIV Proficiency Testing (PT) among enrolled testers,  Verification of HIV Rapid test kit new lot to lot  Post market surveillance of HIV testing kits  National Survey sample testing for Kenya AIDS indicator survey (KAIS) and Kenya Demographic Health Survey (KDH) Sentinel survey for pregnant mothers.

The CD4 monitoring section is involved in:

 Verification and placement of CD4 testing equipment,  Development of protocols for CD4 testing,  Quality audits and rational use of reagents,  Coordination of CD4 EQA program (QASI, HUQAS, sample split for inter-lab comparison)  Benchmarking within CD4 testing networks. 2.3: HIV burden in Kenya HIV is the leading cause of deaths in Kenya (30%) and disease burden (24%). Newly released estimates by the National AIDS and STIs Control Program (NASCOP) indicate the country has a population of 1,380,929 people living with HIV of which 1,219,288 are adults and 161,641 children (NASCOP 2015). Of these, 805,421 adults and 84,269 children were in care by June 2015 while 747,468 adults and 70,619 children were on the highly active antiretroviral therapy (HAART). To achieve the UNAIDS 90-90-90 global targets, the number of PLWHIV on HAART is estimated to rise from the current 818,087 to 1,188,033 by June 2018. 2.3.1: HIV Testing Knowledge of HIV status is the entry point into HIV prevention, care and treatment. Current global target aims at having 90% of all people living with HIV know their HIV status by year 2020. Currently, testing and counseling services are offered at about 6,000 sites in the country through various settings such as Provider Initiated Testing and Counseling (PITC), Prevention of Mother to Child Transmission (PMTCT), and Voluntary Counseling and Testing (VCT). The National guidelines recommend annual testing for; 1. the general population, 2. for pregnant women at 1st ANC visits, and repeat testing in the 3rd trimester for all women who test HIV negative at the first ANC visit, and 3. Every 3 months for high risk (Key) populations and negative partners in discordant couple. Serial testing is used in the country. In the FY 2014/15 the testing algorithm comprised Colloidal Gold (KHB) as the screening test, First Response for confirmatory and Unigold for tiebreaking. Access to HIV testing has gradually increased over the years. In the FY 2014/15, 9,122,660 persons were tested in various testing settings compared to 8.2M in FY 2013/14.

Figure 2.1: HIV Testing Trend (2012-2015) 2.3.2: HIV testing trend in 2014/2015 Testing trend during the year indicate a slight increase in testing volumes from July 2014 to June 2015. On average, 756,783 were tested for HIV per month.