title: Evaluation of a rapid screening test for rifampicin resistance in re-treatment tuberculosis patients in the Eastern Cape.
abstract: OBJECTIVE
  Patients with multidrug-resistant (MDR) tuberculosis (TB) are at high risk of treatment failure. It is anticipated that early identification of MDR-TB and appropriate treatment will improve patient outcome and disease control. We evaluated the rapid detection of rifampicin resistance in previously treated TB patients, directly from acidfast bacilli (AFB)-positive sputum using a phage-based test, FASTPlaque-Response (Biotec Laboratories Ltd, Ipswich, UK). The ability of rifampicin resistance to predict MDR-TB was also determined.
  
  
  METHODS
  A prospective study was done comparing performance of the rapid phage test with conventional culture and drug susceptibility testing (DST) in AFB-positive TB patients.
  
  
  METHODS
  Five primary health clinics and one TB referral centre in the Port Elizabeth Metropolitan area, Eastern Cape.
  
  
  METHODS
  Sensitivity, specificity and overall accuracy of the phage test were determined compared with gold standard culture and DST. Discrepant results were resolved by molecular detection of mutations conferring rifampicin resistance. The proportion of rifampicin-resistant strains that were MDR was also determined.
  
  
  RESULTS
  Previously treated patients were at a high risk of MDRTB (35.7%). Sensitivity, specificity and overall accuracy of FASTPlaque-Response for rifampicin resistance determination were 95.4% (95% confidence interval (CI): 91.0 - 99.8%), 97.2% (95% CI: 94.5 - 99.9%) and 96.5% (95% CI: 94.1 - 98.9%) respectively compared with conventional DST (unresolved), calculated for specimens that had both FASTPlaque-Response and conventional DST results available. FASTPlaque-Response results were available in 2 days instead of 28 - 85 days with conventional DST. However, only 70.6% of FASTPlaque-Response results were interpretable compared with 86.3% of conventional DST results. The majority (95.5%) of rifampicinresistant strains were MDR-TB.
  
  
  CONCLUSIONS
  Rapid detection of rifampicin resistance using FASTPlaque-Response could contribute to improved management of patients at risk of MDR-TB, such as previously treated patients. However, improvement in control of specimen-related contamination is needed to ensure that a higher proportion of FASTPlaque-Response results are interpretable. Where indicated, early modification of therapy could improve patient prognosis and reduce disease transmission.
authors.affiliation: Biotec Laboratories Ltd, Somerset Hospital, Cape Town, South Africa. alberth@mweb.co.za
authors.forename: H
authors.initials: H
authors.lastname: Albert
authors.forename: A P
authors.initials: AP
authors.lastname: Trollip
authors.forename: T
authors.initials: T
authors.lastname: Seaman
authors.forename: C
authors.initials: C
authors.lastname: Abrahams
authors.forename: R J
authors.initials: RJ
authors.lastname: Mole
authors.forename: A
authors.initials: A
authors.lastname: Jordaan
authors.forename: T
authors.initials: T
authors.lastname: Victor
authors.forename: E
authors.initials: E
authors.lastname: Hoosain
mesh_terms: D000904:Antibiotics, Antitubercular / Q000494:pharmacology*; D001434:Bacteriophage Typing / Q000379:methods*; D024881:Drug Resistance, Bacterial; D006801:Humans; D008826:Microbial Sensitivity Tests / Q000379:methods; D009169:Mycobacterium tuberculosis / Q000145:classification / Q000187:drug effects / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D019233:Retreatment; D012293:Rifampin / Q000494:pharmacology*; D013019:South Africa; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000904:Antibiotics, Antitubercular; D012293:Rifampin