EVALUATION OF TB DIAGNOSIS Sample Clauses

EVALUATION OF TB DIAGNOSIS. An outcome classification committee will classify each participant according to the standard case definitions below. The committee will consist of clinician investigators from the participating sites. They will assign a classification of Definite TB, Probable TB, Possible TB or non-TB (see table below) to each participant, as soon as possible after the week 8 follow up time point. Participants started on TB treatment at clinics will be followed up for 6 months to evaluate treatment response. During phase 3 of the study, the committee will remain blind to the point of care TransDot test results on the test cohort, until outcome classification is complete. Screen TB Protocol Version 0.3 May 2016 The case definitions will be applied as shown in the table below: Pos = positive; neg = negative; con = contaminated; GR = good response; PR = poor response; NG = none given Category Culture GeneXpert AFB smear CXR Symptoms TB Treatment started by clinic TB Treatment response Response to antibiotic (AB), if prescribed Class A pos pos Definite B neg or con pos (no TB in past year) pos Definite C neg or con neg or pos (TB in past year) pos pos pos yes GR Definite D neg or con neg or pos (TB in past year) pos neg pos yes GR Probable E neg or con neg or pos (TB in past year) neg pos pos yes GR Probable F neg or con neg or pos (TB in the past year) neg pos pos No PR Possible G neg or con pos (TB in past year) neg neg pos yes GR Possible H neg neg neg pos pos no GR No TB I neg neg neg neg pos no NG No TB J Not done or con Not done Not done Exclude K Not done or con pos (TB in past year) pos or neg neg or not done pos yes PR Exclude L Not done or contam Pos TB in past year pos or neg neg or not done pos no NG PR Exclude Definitions: TB symptoms or signs: symptoms volunteered or specifically elicited by interviewer and signs objectively observed by examiner that include Cough ≥ 2 weeks; Fever (subjective, present ≥ 2 weeks); Weight loss (significant, unintentional loss of ≥ 10% of body weight in last 6 months. If no previous weight available, the patient’s judgement of weight loss will be used); Haemoptysis (blood stained to blood clots); Wasting (clinical finding of examining health care professional) ; Night sweats (drenching of sleeping clothes or bedding, not related to environment); Adenopathy (clinical finding of significantly enlarged lymph nodes by examining health care professional), of particular significance in HIV co-infected individuals; Other: may be considered...
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