Roll Out of GeneXpert Rapid TB Testing

Swaziland, a small country with a population of 1.2 million, has the highest estimated TB incidence rate in the world at 1,349 per 100,000 in 2012.1 The TB epidemic in Swaziland

is further compounded by high rates of drug-resistant TB (DR-TB) which account for 7.7% of all new TB cases and 34% of all

C e n t e r s f o r D i s e a s eC o n t r o l a n d P r e v e n t i o n

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URC/CDC Lab ProjectSince September 2009, University Research Co., LLC (URC) has implemented the HIV and TB related Laboratory Support and Technical Assistance project (known as the URC/CDC Lab project) funded by the Centre for Disease Control and Prevention in Swaziland. In close coordination with the Ministry of Health through the Swaziland Health Laboratory Services (SHLS), the project works to strengthen laboratory services at all levels, implement quality management systems, and expand HIV/AIDS and TB diagnostic and laboratory monitoring services within the Swaziland health system. With the increasing health burden in a limited resource setting, the need for cost effective, accessible and equitable delivery of health services is more urgent today than ever before and this project is aimed at filling a critical need for clinical laboratory support for disease surveillance, diagnosis, and treatment response monitoring.

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retreatment cases. Swaziland also reports one of the highest HIV prevalence in the world. Around 77% of TB patients are co-infected with HIV, and the risk of developing TB is between 20 and 37 times greater in people living with HIV than among those who are not infected with HIV.2

This heavy burden of DR-TB and TB/HIV complicates efforts to provide TB prevention, diagnosis, and treatment services to all Swazis. Many people die from TB because of delays in testing and diagnosis. Traditional smear microscopy only detects TB in 20% to 80% of TB cases (using fluorescence microscopy methods) and has significant limitations in detecting cases of insufficient bacillary load (those who are HIV-infected) or detecting drug resistance (those with DR-TB). Culture and drug-susceptibility testing (DST) requires expensive and sophisticated lab infrastructure and the process can take 42 days, depending on the ability of viable bacilli to grow. Line probe assay is dependent on smear results (which further increases turn-around-time to patients) and is prone to contamination and human error.

GeneXpert Rapid TB Testing Early diagnosis is essential to achieving significant reductions in death and disability as a result of TB and HIV. In December 2010, the World Health Organization (WHO) endorsed Xpert MTB/RIF (GeneXpert), a

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rapid testing machine offers a major breakthrough in overcoming the limitations outlined above. GeneXpert can simultaneously diagnose TB and detect resistance to rifampicin, one of the most important anti-TB drugs. This molecular based rapid test simplifies molecular testing by fully integrating and automating the three processes (sample preparation, amplification and detection) required for real-time PCR-based molecular testing. The assay provides results directly from sputum in two hours - and has the potential to greatly reduce the delay between sputum sample collection and treatment initiation for patients with suspected DR-TB. This test can also diagnose up to 72% of smear negative pulmonary TB. In an effort to improve the diagnostic capacity for drug susceptible and drug resistant TB, Swaziland was among the first countries to adopt and implement GeneXpert as a replacement of smear microscopy for all people presenting with TB symptoms.

Given the high HIV prevalence among incident TB cases in Swaziland, GeneXpert is performed as an initial diagnostic test for all persons with presumptive TB and for all previously treated TB cases. Where the equipment is unavailable, access to an off-site laboratory with equipment is possible through efficient sample transportation.

Introducing and Scaling Up GeneXpert NationwideThrough the URC/CDC Lab Project, URC is working actively with the Swaziland Ministry of Health (MOH), through the National TB Control Program and the Swaziland Health Laboratory Services (SHLS) to strengthen national capacity to lead and manage roll-out

of GeneXpert MTB/RIF diagnostics in order to decentralize TB testing and ensure swifter, more accurate diagnosis and initiation of patients onto treatment.

The National TB Program began scaling up roll out of GeneXpert testing in 2012. Figure 1 below shows the increase in the number of GeneXpert tests performed at the Mbabane National Reference Laboratory and the TB Hospital during FY2013.

Capacity Building of Laboratory and Clinical Staff

The URC/CDC Lab Project is supporting the MOH to provide training for microscopists deployed at TB diagnostic sites to improve their skills on operating the GeneXpert instrument. Lab managers are also provided GeneXpert training so they are able to transfer these skills to their subordinates. Finally, clinicians and health care workers are being trained on updated clinical guidelines to diagnose TB via GeneXpert.

Strengthening External Quality Assessment (EQA) for GeneXpert

In 2013, the URC/CDC Lab Project conducted an EQA of 15 GeneXpert sites throughout Swaziland. Results of this assessment showed that from April - June 2013, 93% (14 out of 15 participating facilities) attained an acceptable performance score of 100%.

Strengthening Sample Transport Systems

For laboratory services to be delivered in efficient, timely, and accessible manner, strong supportive systems must be in place to carry patient samples to the laboratory sites and to return

Figure 1: Facility test statistics - GeneXpert

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Distribution of Project GeneXpert Machines

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diagnostic results. With URC/CDC Lab Project assistance, the Swaziland National Sample Transport System (NSTS) currently reaches 116 facilities served by 5 mother laboratories (referred to as ‘hubs’), transporting patient specimens from rural clinics to hubs for testing and returning results. Through continual technical assistance, the project has assisted to improve efficiencies and coverage for the NSTS. Additionally, NSTS has assisted in the distribution of laboratory reagents/commodities and external quality assurance samples to peripheral sites. The NSTS has been critical in reducing the number of specimens rejected by laboratory sites as well as in decreasing turn-around-time of patient results.

As of March 2014, 26 GeneXpert machines (25 GX4 and one GX16) have been placed throughout Swaziland’s four regions.

1 WHO Swaziland TB Country Profile, 2012: https://extranet.who.int/sree/Reports?op=Replet&name=/WHO_HQ_Reports/G2/PROD/EXT/TBCountryProfile&ISO2=SZ&outtype=html.

2 Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.

Rogers KisameSenior Laboratory Technical Advisory/Team Lead

+268 2404 7154rogersk@urc-sa.com

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