Tuberculosis cure rates and the ETR.Net: investigating the quality of reporting treatment outcomes from primary healthcare facilities in Mpumalanga province, South Africa.

BACKGROUND: Tuberculosis control programs rely on accurate collection of routine surveillance data to inform program decisions including resource allocation and specific interventions. The electronic TB register (ETR.Net) is dependent on accurate data transcription from both paperbased clinical records and registers at the facilities to report treatment outcome data. The study describes the quality of reporting of TB treatment outcomes from facilities in the Ehlanzeni District, Mpumalanga Province. METHODS: A descriptive crossectional study of primary healthcare facilities in the district for the period 1 January - 31 December 2010 was performed. New smear positive TB cure rate data was obtained from the ETR.Net followed by verification of paperbased clinical records, both TB folders and the TB register, of 20% of all new smear positive cases across the district for correct reporting to the ETR.Net. Facilities were grouped according to high (>70%) and low cure rates (≤ 70%) as well as high (> 20%) and low (≤ 20%) error proportions in reporting. Kappa statistic was used to determine agreement between paperbased record, TB register and ETR.Net. RESULTS: Of the100 facilities (951 patient clinical records), 51(51%) had high cure rates and high error proportions, 14(14%) had a high cure rate and low error proportion whereas 30(30%) had low cure rates and high error proportions and five (5%) had a low cure rate with low error proportion. Fair agreement was observed (Kappa = 0.33) overall and between registers. Of the 473 patient clinical records which indicated cured, 383(81%) was correctly captured onto the ETR.Net, whereas 51(10.8%) was incorrectly captured and 39(8.2%) was not captured at all. Over reporting of treatment success of 12% occurred on the ETR.Net. CONCLUSIONS: The high error proportion in reporting onto the ETR.Net could result in a false sense of improvement in the TB control programme in the Ehlanzeni district.

Evaluation of the GenoType MTBDRsl Version 2.0 Assay for Second-Line Drug Resistance Detection of Mycobacterium tuberculosis Isolates in South Africa.

Early detection of resistance to second-line antituberculosis drugs is important for the management of multidrug-resistant tuberculosis (MDR-TB). The GenoType MTBDRsl version 2.0 (VER 2.0) line probe assay has been redesigned for molecular detection of resistance-conferring mutations of fluoroquinolones (FLQ) (gyrA and gyrB genes) and second-line injectable drugs (SLID) (rrs and eis genes). The study evaluated the diagnostic performance of the GenoType MTBDRsl VER 2.0 assay for the detection of second-line drug resistance compared with phenotypic drug susceptibility testing (DST), using the Bactec MGIT 960 system on Mycobacterium tuberculosis complex isolates from South Africa. A total of 268 repository isolates collected between 2012 and 2014, which were rifampin monoresistant or MDR based on DST, were selected. MTBDRsl VER 2.0 testing was performed on these isolates and the results analyzed. The MTBDRsl VER 2.0 sensitivity and specificity indices for culture isolates were the following: FLQ, 100% (95% confidence interval [CI] 95.8 to 100%) and 98.9% (95% CI, 96.1 to 99.9%); SLID, 89.2% (95% CI, 79.1 to 95.6%) and 98.5% (95% CI, 95.7 to 99.7%). The sensitivity and specificity observed for individual SLID were the following: amikacin, 93.8% (95% CI, 79.2 to 99.2%) and 98.5% (95% CI, 95.5 to 99.7%); kanamycin, 89.2% (95% CI, 79.1 to 95.6%) and 98.5% (95% CI, 95.5 to 99.7%); and capreomycin, 86.2% (95% CI, 68.3 to 96.1%) and 95.9% (95% CI, 92.2 to 98.2%). An interoperator reproducibility of 100% and an overall interlaboratory performance of 93% to 96% were found. The overall improvement in sensitivity and specificity with excellent reproducibility makes the GenoType MTBDRsl VER 2.0 a highly suitable tool for rapid screening of clinical isolates for second-line drug resistance for use in high-burden TB/HIV settings.