Table 1.
Study | Year | Country | Prospective data collection | Double or single blinding | Index test used | Specific details of index test used | Number of patients | Specimens per patient | Reference standard | Reported sensitivity | Reported specificity |
---|---|---|---|---|---|---|---|---|---|---|---|
Khan et al. [41] | 2013 | Pakistan | Yes | No | In-house | Real Time PCR IS6110, MPB-64, 16rRNA | 50 | 3 CMUS | A | 88·6 | 96·5 |
Garcia-Elorriaga et al. [42] | 2009 | Mexico | No | No | In-house | Nested PCR 32-kDa, MTP40 and IS6110 |
20 | 1 | a | 100 | 82 |
Khosravi et al. [43] | 2010 | Iran | Yes | No | In-house | Nested PCR IS6110 |
200 | 1 | A | 100 | 100 |
Raghavendran et al. [44] | 2016 | India | Yes | No | In-house | PCR (gene target nor reported) | 48 | 1 | A | 89·5 | 89·6 |
Hemal et al. [45] | 2000 | India | Yes | No | In-house | PCR MPB-64 |
42 | Unknown | b | 94·3 | 85·7 |
van Vollenhoven et al. [46] | 1996 | South Africa | Yes | No | In-house | PCR M13 mp8 |
82 | Unknown | A | 100 | 100 |
Moussa et al. [47] | 2000 | Egypt | Yes | No | In-house | PCR 16S rRNA | 1000 | 3 CMUS | A | 87·05 | 98·9 |
Moussa et al. [47] | 2000 | Egypt | Yes | No | In-house | PCR IS6110 | 1000 | 3 CMUS | A | 95·59 | 98·11 |
Gamboa et al. [48] | 1998 | Colombia | Yes | No | Commercial | LCx M. Tuberculosis Assay | 69 | Unknown | A | 70 | 100 |
Hillerman et al. [49] | 2011 | Germany | Yes | Yes | Commercial | Xpert MTB/RIF | 91 | 1 | A | 100 | 98.6 |
Tortoli et al. [50] | 2012 | Italy | Yes | Yes | Commercial | Xpert MTB/RIF | 130 | 1 | B | 87·5 | 99·1 |
CMUS continuous day- morning urine sample, A microbiological reference standard (positive culture), B broad reference standard (either a positive culture or clinical manifestations with adequate treatment response after a minimum one-month follow-up); aFinal Physician Decision considering culture and treatment response; badvanced and typical radiologic findings, positive urine smear or culture, and histologic examination of a biopsy or surgically resected specimen