Feasibility and Sensitivity of Saliva GeneXpert MTB/RIF Ultra for Tuberculosis Diagnosis in Adults in Uganda

Abstract

Tuberculosis is among the leading causes of morbidity and mortality worldwide, in large part because >3 million people go undiagnosed and untreated each year. Sputum has been the mainstay for TB diagnosis for over a century but can be difficult for patients to produce.

Accuracy of upper respiratory tract samples to diagnose Mycobacterium tuberculosis: a systematic review and meta-analysis

“…From included manuscripts (appendix pp 26–33 for study characteristics; appendix p 5 includes full methodological details and results by study), we classified types of upper respiratory tract sampling into four groups: laryngeal swabs (32 studies 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 ), nasopharyngeal aspirate (ten studies 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 ), oral swabs (18 studies 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 ), and other (mouthwash three studies, 71 , 72 , 73 nasal swabs one study, 74 saliva four studies, 75 , 76 , 77 ,…”

“…From included manuscripts (appendix pp 26-33 for study characteristics; appendix p 5 includes full methodological details and results by study), we classified types of upper respiratory tract sampling into four groups: laryngeal swabs (32 studies ), nasopharyngeal aspirate (ten studies [43][44][45][46][47][48][49][50][51][52] ), oral swabs (18 studies [53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70] ), and other (mouthwash three studies, [71][72][73] nasal swabs one study, 74 saliva four studies, [75][76][77][78] and other mucosa or dental samples three studies [79][80][81] ). Studies were published between May 13, 1933, and Dec 19, 2022, from South Africa (11 studies), Norway (seven studies), UK (seven studies), Peru (four studies), Uganda (seven studies), Canada (three studies), India (three studies), USA (three studies), Australia (two studies), Germany (two studies), Kenya (two studies), and one study from each of Brazil, Chile, China, Slovakia and Czech Republic, Denmark, Finland, France, Hungary, Italy, Japan, Malawi, Moldova, Mozambique, South Korea, southeast Asia (individual countries not specified), Spain, Sweden, Taiwan, Turkey, and Yemen.…”

Oral swabs with a rapid molecular diagnostic test for pulmonary tuberculosis in adults and children: a systematic review

“…In addition, this is a rapidly developing field, and a modified search update identified additional evidence published or submitted since the full search was completed on Aug 23, 2023. Although no additional studies using swabs have been published, additional studies 28 have continued to explore saliva with findings of good sensitivity comparable with the highest sensitivities seen with oral swabs.…”

Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study

“…In a previous report by Shenai and coresearchers, the X-Classic showed a lower sensitivity in detecting MTB from saliva specimens compared with testing on sputum samples isolated from the same patients [ 21 ]. However, a recent study conducted in Uganda revealed that X-Ultra on a single saliva sample produced a sensitivity of 90% relative to the composite MGIT reference standard [ 22 ]. The use of X-Ultra and enrollment of only individuals with definite TB may explain the promising sensitivity of X-Ultra on saliva specimens in the latter study.…”