An assessment of nucleic acid amplification testing for active mycobacterial infection


Appendix Study profiles of studies included in the assessment



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Appendix Study profiles of studies included in the assessment


Table Study profiles of included studies providing direct evidence on the effectiveness of NAAT on patients suspected of having TB

Study setting

Study design
Quality appraisal


Study population

Selection criteria

Intervention

Comparator

Outcomes

Theron et al. (2014)

University of Cape Town, South Africa

Conducted at:

Five primary healthcare facilities in areas with a high HIV prevalence in South Africa, Zimbabwe and Tanzania



Randomised controlled trial (multicentre)

Level: II

Quality: 23/26

Low risk of bias



N=1,502

Median age: 37 years (IQR 30–46), 643 (43%) females, 895 (60%) HIV infected

758 assigned to AFB microscopy

744 assigned to Xpert MTB/RIF



Inclusion:

> 17 years of age, one or more symptoms of pulmonary TB (according to WHO criteria), able to provide sputum specimens, no anti-TB treatment in past 60 days



Exclusion:

Not reported



Xpert MTB/RIF on sputum specimen by nurse who received a 1-day training session

AFB microscopy on sputum specimen Positive if any smear revealed AFB over 100 fields (1000x for light microscopy and 400x for fluorescence microscopy)

TB-related morbidity after 2 and 6 months (using TBscore and Karnofsky performance score)

Mortality at 6-month follow-up

Failure rates


Yoon et al. (2012)

Division of Pulmonary and Critical care Medicine, San Francisco General Hospital, University of San Francisco, San Francisco, California, USA

Conducted at:

Mulago Hospital, Kampala, Uganda



Historical cohort study

Level: III-3

Quality: 18.5/26

Some risk of bias



N=477/525 included

Median age: 33 years (IQR 27–40), 229 (48%) female, 362 (76%) HIV infected



Inclusion:

Consecutive adults > 17 years of age admitted to hospital with cough > 2 weeks but < 6 months duration and provided consent



Exclusion:

Receiving TB treatment at the time of enrolment, no available culture results, no NAAT on implementation phase, death within 3 days of hospital admission



GeneXpert MTB/RIF, sputum AFB microscopy and mycobacterial culture

Same tests, but in comparator group Xpert results were not reported to clinicians or used for patient management

2-month mortality

IQR = interquartile range; NAAT = nucleic acid amplification test; TB = tuberculosis; WHO = World Health Organization

Table Study profiles of included studies on diagnostic accuracy




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