NHRL is a unit under the division of National Public Health Laboratory (NPHL) within the department of laboratory services. It was established by the Ministry of Health in 2003 to provide oversight of Laboratory HIV Quality Assurance services for the National HIV Program – NASCOP. The NHRL was the first government laboratory to be accredited in the country in 2012 under ISO 15189:2012 for three scopes: Viral Load (VL), Early infant diagnosis (EID) and serology and ISO 17043:2010 for two scopes: VL, EID. NHRL attained WHO HIV DR Accreditation in 2021 as the first government public health laboratory to achieve such.

Mandate

  • NHRL is involved in the formulation/Review of HIV Lab policies and guidelines, development and updating of HIV lab policies for diagnosis and HIV quality management.
  • The laboratory coordinates and provides technical guidance in the delivery of HIV Laboratory services
  • Coordinates the HIV Diagnosis (HIV Rapid and Early infant diagnosis (EID) and treatment Monitoring Viral load (VL) trends in 12 centralized VL&EID in the Current 12 testing laboratories and in EID/VL Point of care, and HIV DR in line with the global targets of 95:95:95.
  • NHRL monitors the impact of growing HIV Epidemic in the country
  • The lab coordinates and tests all reference specialized HIV testing services HIV (VL, EID, HIVDR) and HIV related tests CD4.
  • HIV reference panel (PT) production, distribution and provide intervention of the HIV test analytes. In peer participating laboratories (HIV rapid recency, VL, EID, CD4 and HIV DR).
  • HIV QA activities of test Analytes (serology, RTRI, VL/EID, CD4, DRT, and currently Covid 19)
  • Pre and Post markets surveillance of HIV tests kits (Rapid, molecular tests kits) (Pre-distribution lot verification) and post distribution lot verification, to check the quality of kits that are in use in facilities across the country
  • HIV Kits, Equipment verification/validations
  • Conducting HIV population-based surveys and surveillance (KAIS, PHIA, Recency, KDHS, HIVDR) together with NASCOP.
  • Conducting training and mentorship of HIV laboratory service providers in the country.
  • Analysis of HTS inconclusive samples from all county facilities using DNA PCR.
  • Optimization of HIV diagnostic referral networks
  • HIV drug-resistance assays for the patients with suspected therapy failure.

Laboratory sections

  • Sample reception & management: samples are received from across the country. Samples received include dry blood spot filter paper, whole blood for CD4s, plasma. Once samples are received, they are taken through sample acceptance and rejection criteria which is predetermined. The samples that require cold chain are deep frozen at -80, -40 degrees Celsius awaiting testing. These samples include plasma and any other study sample type. The requisition forms are taken to the data entry section for logging into the LIMS.
  • Serology section: this section does serological surveillance and post-market surveillance. The section largely is solely involved for studies and surveys, preparation of Proficiency Testing (PT) panels for Recency study. The section also does CD4 and coordination of PT.
  • Molecular section: there are 3 subsections within this section:
    1. Early infant diagnostic section (EID)
    2. Viral Load section
    3. Drug Resistance Testing

Drug Resistance Testing

This section does HIV DR testing which includes:

  • Pre-treatment (before initiating ART) surveys
  • Acquired Drug Resistance (ADR) Surveys
  • Regimen Optimization
  • ART switching decision; on patients failing 2nd line regimen and switching to 3rd line regimen and those failing a 1st line protease inhibitor-based regimen (pediatrics).

Test menu

TestWalk-in/Referral serviceFree/chargeableExpected TAT
CD4ReferralFree72 hours
SerologyReferralFree10 days
EIDReferralFree5 days
HTS Inconclusive DNA PCRReferralFree5 days
Viral LoadReferralFree10 days
DRTReferralFree10 days
Studies/surveysReferralFreeProtocol driven

List of accreditations/licensure

  • ISO 15189:2012 standards – KENAS
  • ISO 17043 standards – KENAS

Downloads

Kenya ARV Guidelines 2022Download