Diagnostic Services

CENTRAL TB AND LEPROSY REFERENCE LABORATORY 

Biography

Our website offers you an overview of our activities, functions, services, events, and publications. It takes you through what CTRL is all about, our motivation and aspiration. We are really looking forward to offering a Tuberculosis diagnosis service in applicable standards and offering standardization and quality assurance services. Thank you for visiting our website. And, you can visit us at Muhimbili National Hospital, 3rd Floor, Central Pathology Laboratory, Dar es Salaam, Tanzania.

Welcome.

Dr. Basra Doulla - Laboratory Head

Central Tuberculosis Reference Laboratory

Historical Background

CTRL is SADCAS accredited Central Tuberculosis Reference Laboratory established by the government as part of the efforts to strengthen the management of Tuberculosis diagnosis in the country. The CTRL operates under the National Tuberculosis and Leprosy Program mandated to oversee the TB diagnostic services in TB diagnostic network. The Central TB and Leprosy Reference Laboratory (CTRL) was established in 1968 with assistance from the British Medical Research Council (BMR) purposely for research in TB disease and thereafter the CTRL operates under NTLP establishment in 1977.

Roles and Functions

CTRL has the following major functions:

• To provide diagnostic as well as surveillance and monitoring of Tuberculosis (TB) services in the country. These include smear Microscopy, Culture and DST, Gene Xpert MTB/RIF/Ultra, and Line Probe Assay (LPA)
• To provide coordination, supportive supervision, proficiency testing on TB tests, and capacity-building for all TB laboratories public and private sectors.
• To establish national standards and oversee the implementation of national policies for TB laboratory investigations
• To coordinate with the Zonal TB Reference Laboratories (ZTRL) on performing culture first-line DST for the country
• To plan and coordinate training, supervision, and external quality assurance
• To Provide technical advice for strengthening laboratory services within the network,
• To Promote and coordinate an effective specimen referral system within and outside the country.
• To conduct TB operational research,
• To organize and conducts training and supervision of zonal and peripheral TB laboratories.
• To Implement the Quality Management System (QMS) that complies with ISO 15189:2012 version and World Health Organization requirements.
• To develop quality objectives which are throughout the different levels within the laboratory and review them annually during the management review (under 4.1.2.4)
• To produce accurate and reliable results that meet the Laboratory established turnaround times (TAT)
• To ensure there are adequate resources, supplies, and reagents in order to provide quality services
• Ensure that all TB laboratory staff are qualified and competent to carry out their daily task and that they are familiar with quality system documentation in order to implement the policies and procedures in their work
• To ensure TB laboratory staff adhere to the professional code of ethics, safe and good Laboratory practices
• To ensure that all processes of the quality management system conform to ISO 15189, and that are continuously reviewed to ensure continuous development and improvement
• To ensure that all examination procedures are fit for intended use and comply with the requirements of the international standard
• To ensures that Laboratory staff understand the quality policy and follow its principles in the course of their daily work
• To review the quality policy for continuing suitability in order to keep updated with knowledge and technological developments
• To maintain collaboration with the World Health Organization (WHO), the International Union against Tuberculosis and Lung Disease (IUATLD), and Supra-National Reference Laboratory (SNRL)
• To strengthen quality systems in TB diagnostic network
• To link with the private sector and regulatory bodies to ensure smooth and integrated implementation of NTLP activities in the country

Available offered tests and intended use

CTRL currently follow NTLP testing Algorithm for the tests offered

1. Microscopy
   1. Fluorescence Microscopy (FM)
   2. Ziehl-Neelsen Smear Microscopy (ZN Microscopy)

Whereas microscopy is Intended for TB diagnosis and treatment management, at CTRL microscopy is used for only treatment management. Whoever ZN microscopy is mainly used for diagnosis of Leprosy

2. Mycobacterium TB Culture
   1. Löweinsten-Jensen solid Media Method (LJ Culture)

Intended for TB diagnosis and treatment management

1. 2. Mycobacterial Growth Indicator Tube (MGIT) method

Intended for TB diagnosis and treatment management,

3. Drug susceptibility testing (DST)
   1. Löweinsten-Jensen solid Media Method

Intended for diagnosis of MDR or XDR TB and routine drug resistance Surveillance.

1. 2. LPA (HAIN Test)

Intended for rapid diagnosis of rifampin, Isoniazid, ofloxacin and injectables resistance. Intended for rapid diagnosis of MDR or XDR TB, routine drug resistance Surveillance and management of MDR treatment

1. 3. Xpert MTB/Ultra/RIF

Intended for rapid diagnosis of TB and Rifampicin resistance

Results Turnaround Time

Turnaround Time is the usual amount of time between the time a specimen is received within the laboratory and the time result is available. The TAT for the various tests performed at the CTRL is shown in the table below:

Other service offered by CTRL

1. Training on TB Laboratory Diagnostic techniques for FM and ZN Microscopy, LJ Drug

susceptibility Testing, MGIT 1ST AND 2ND LINE DST, LPA 1ST AND 2ND LINE DST,Truenat and GeneXpert

2. Laboratory Quality Management System
3. TB specimen referral system

Laboratory Quality Management System

CTRL is SADCAS accredited laboratory, providing Technical Assistance on the TB diagnostic laboratories in the entire TB diagnostic network within the country, supporting accreditation process in the laboratories seeking international accreditation specifically on TB diagnostic tests. The TA includes the provision of PT for Genexpert and method verification External Quality Assurance

TB specimen referral system                                                                                                                                                            

Sample referral System follow Spoke to Hub model

The SRS integrated with other disease programs like Malaria and HIV sample referral operational across the country, standard national guideline for integrated specimen referral that assures enforcement and sustainability

SRS is facilitated by a contract agreement between MoH and Tanzania Post Corporation.

CTRL Vision

To provide well-coordinated, high-quality, sustainable, nationwide TB Laboratory services that are accessible and affordable to all.

CTRL Mission

Ensure high-quality, efficient TB Laboratory services at all levels of public and private laboratories, functioning according to accepted national standards.

How CTRL operate

TB Diagnostic laboratory services are managed by the Central TB reference laboratory (CTRL) through the National TB control Program (NTLP) under the Ministry of Health.

Government supports TB diagnostic network of laboratories that provide services for TB diagnosis and treatment monitoring for patient care.

Number and distribution of laboratories within the network vary dramatically depending on several factors including geography, disease burden, economic setting, and political implications.

Structure of TB Diagnostic network in the country

TB laboratory diagnostic network comprises with a total of 1900 (2022) diagnostic centers

The network operates at four levels

1. • National levels 
   • Zonal level
   • Intermediate level
   • Peripheral Laboratories