An assessment of nucleic acid amplification testing for active mycobacterial infection



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Study setting

Study design
Quality appraisal


Study population

Selection criteria

Intervention

Comparator

Outcomes

Ponticiello et al. (2001)

Monaldi Hospital, Naples, Italy

TB referral center for Campania


Prospective cohort study

Level: III-2

Quality: 16/26

High risk of bias



N=90 cases of TB

100% Caucasian

48 (53%) had cavity type lesion on chest X-ray

Average delay in diagnosis 2.25 ± 1.0 months

3 (2.7%) TST-negative

Contacts:

N=277 (out of 346 identified contacts)

44 did not comply with protocol

25 refused consent


Inclusion

All patients with newly diagnosed pulmonary TB during the period January 1997 – December 1998 and their contacts (those sharing the same indoor environment for prolonged periods)

AFB in sputum or bronchial smear and positive culture for MTB

Exclusion

Patients with HIV and their contacts

No written informed consent

Failure to comply with study protocol



Delay to diagnosis ≤ 1 month

Delay defined as period from onset of any TB symptoms to diagnosis



Delay in diagnosis:

1.5 months

2.0 months

(also examines up to 5 months)



Proportion of contacts TST-positive

Proportion of contacts TST-negative

Odds TST+/TST–

OR (TST+/TST–) Various lengths of delay compared with reference ≤ 1 month delay



Analysis of clinical risk factors

ORs and their 95%CIs were calculated by means of univariate and multivariate logistic regression



Golub et al. (2006)

Maryland, USA



Prospective cohort study

Level: III-2

Quality: 16/26

High risk of bias



N=124 total patients with pulmonary TB included

34 excluded due to no contacts identified/tested

N=54 (44%) born in USA

US patients:

65% male


72% black

59% < 50 years of age

57% AFB sputum-positive

19% chest X-ray with cavitation

385 contacts, of whom 310 (81%) skin tested


Inclusion

All verified pulmonary TB patients who reported to the Maryland Department of Health and Mental Hygiene between 1 June 2000 and 30 November 2001 and their close contacts

Close contacts included those living in the same household, working in a closed environment with patient, and reported close friends and relatives

Exclusion

No contacts identified or no contacts tested



Treatment delay either:

≤ 60 days or

≤ 90 days

Delay treated as a dichotomous variable, analysed for cut-offs of 60 and 90 days

Total treatment delay defined as interval from first TB symptoms to initiation of treatment for TB


Treatment delay > 60 days

Treatment delay > 90 days



Number of contacts infected TST-positive (tested at baseline and 10–12 weeks later)

Van der Oest, Kelly & Hood (2004)

Waikato Health District, New Zealand



Retrospective cohort study

Level: III-2

Quality: 11/26

High risk of bias



N=244 (189 new cases, 37 relapse cases, 18 unclassified):

52% male

110 (45%) Maori

46 (19%) non-Indigenous New Zealanders

81 (33%) born overseas, 40 of whom were refugees

number with length of diagnostic delay reported 152 (62% of cases)

outcome of treatment reported for 214 (88%) of cases


Inclusion

All notified cases of TB who were residing in the Waikato Health District at the time of notification from 1 January 1992 to 31 December 2001



No diagnostic delay

Delay defined as time between development of symptoms and notification/diagnosis of the case



Increasing diagnostic delay

Favourable treatment outcome as defined by WHO (i.e. cure or treatment completed)

Statistical analysis

Logistic regression was used for multivariate and univariate comparisons

Chi-square test


AFB = acid-fast bacilli; HIV = human immunodeficiency virus; OR = odds ratio; TB = tuberculosis; TST = tuberculin skin test; WHO = World Health Organization

Table Study profiles of included studies on the effectiveness of change in management due to rifampicin-resistance mutations being identified




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