Test characteristics and potential impact of the urine LAM lateral flow assay in HIV-infected outpatients under investigation for TB and able to self-expectorate sputum for diagnostic testing

摘要: The commercially available urine LAM strip test, a point-of-care tuberculosis (TB) assay, requires evaluation in primary care setting where it is most needed. There currently inadequate data to guide implementation TB and HIV-endemic settings. Adult HIV-infected outpatients with suspected pulmonary able self-expectorate sputum from four clinics South Africa, Zambia Tanzania underwent diagnostic [sputum smear microscopy, Xpert-MTB/RIF, culture (reference standard)] as part of prospective parent study. Urine testing (grade-2 cut-point) was performed on archived samples. Performance characteristics alone or combination sputum—based diagnostics were evaluated. Potential impact 2 6-month morbidity (TBscore), patient dropout rates, prognosis (death/ loss follow-up) Among 583 participants that refused testing, the overall sensitivity (95 % CI; n/N) CD4 ≤ 100 cells/mm3 sub-group 22.7 (16.6-28.7; 41/181) 30.4 (17.1-43.7; 14/46), respectively. Overall specificity 93.0 (90.5-95.6; 361/388). Amongst culture-positive cases, adjunctive did not improve either Xpert-MTB/RIF [78.2 (69.8-86.7; 72/92) versus 76.1 (67.4-84.8; 70/92), p = 0.7] smear-microscopy [56.2 (45.9-66.5; 50/89) 43.8 (33.5-54.1; 39/89), p = 0.1). Clinic-based LAM, an adjunct microscopy Xpert MTB/RIF same-day would neither have decreased dropout, nor increased treatment initiation this clinical chest radiography available. positivity associated lost-to-follow-up/death (AOR 4.4; p = 0.002) but TBscore (at baseline change 2-months post-treatment) (p = 0.17). In African HIV-TB co-infected had limited even at low CD4 counts, offered no significant incremental yield over microscopy. empiric common, seems unlikely rates however, ability identify patients high risk death lost-to-follow-up may offer important prognostic value.