Performance of three LED-based fluorescence microscopy devices in detection of tuberculosis in HIV-positive suspects in Kampala, Uganda, per specimen analysis.

*<p>For sensitivity calculations, the denominator is the number of specimens for which the culture was positive for MTB. For specificity, the denominator shows the number of culture negative specimens.</p

Diagram of study flow.

<p>NTM =  non-tuberculous mycobacteria, Mtb  =  <i>Mycobacterium tuberculosis</i>.</p

Performance of three LED-based fluorescence microscopy devices in detection of tuberculosis in HIV-positive suspects in Kampala, Uganda, per patient analysis.

*<p>For sensitivity calculations, the denominator is the number of patients for which the culture was positive for MTB. For specificity, the denominator shows the number of culture negative patients. None of the 3 LED FM methods was significantly different from each other. ZN, ZiehlNeelsen staining method; FM, fluorescence microscopy; PPV, positive predictive value; NPV, negative predictive value.</p

False positive results.

<p>False positive results.</p

Sensitivities compared to positive culture (LJ or MGIT) at different CD4 T cell strata.

<p>Empty cells under reader 5 show that there were 13 patients and all tested negative for all 3 tests (i.e. iLed, Lumin, and Fraen). Overall-4 represents the overall sensitivities of readers 5 & 6 excluding reader 4 who had the highest false positivity rate. Table includes only those patients with a CD4 count record.</p

Per reader analysis of performance of ZN and LED-based fluorescence microscopy methods, per specimen analysis.

<p>Readers 1–3 read ZN slides, readers 4–6 read LED FM slides (all LED systems for a single specimen were read by the same reader).</p

User appraisal of LED FM systems.

<p>User appraisal of LED FM systems.</p

Per reader analysis of performance of ZN and LED-based fluorescence microscopy.

<p>*one-sided, 97.5% confidence interval.</p

Average Examination time of ZN and LED FM methods, related to smear grading.

<p>*1 slide only.</p

Intra and inter-reader variability.

<p>Intra-reader variability refers to re-reading of slides by the same reader.</p><p>Inter-reader variability refers to re-reading of slides by a second reader.</p><p>HFP, high false positive; LFP, low false positive; LFN, low false negative; QE, quantification error.</p