A Rapid and Sensitive Diagnostic Screening Assay for Detection of Mycobacteria Including Mycobacterium tuberculosis Directly from Sputum without Extraction

Table 1

Mtb detection and GeneXpert head to head clinical evaluation results.

Sample number	Sample type	Smear result	Culture	GeneXpert result	Mtb detection result	Days to positivity	Reference lab ID
1	Sputum	Neg	Neg	Pos	Pos
2	Sputum	Pos	Pos	Pos	Pos	6	M.tuberculosis
3	Sputum	Pos	Pos	Pos	Pos	5	M.tuberculosis
4	Sputum	Pos	Pos	Pos	Pos	4	Mycobacterium sp.
5	Sputum	Pos	Pos	Neg	Neg	11	Mycobacterium sp.
6	Sputum	Neg	Pos	Neg	Neg	8	M.kansasii
7	Sputum	Pos	Pos	Neg	Neg	5	M.kansasii
8	Sputum	Pos	Pos	Neg	Neg	5	M.kansasii
9	Sputum	Neg	Pos	Pos	Pos	14	M.tuberculosis
10	Sputum	ND	ND	Pos	Neg
11	Sputum	Pos	Pos	Pos	Pos	4	M.tuberculosis
12	Bronchial washing	Neg	Neg	Neg	Pos
13	Bronchial washing	Neg	Neg	Neg	Pos
14	Bronchial washing	Neg	Pos	Pos	Pos	8	M.tuberculosis
15	Bronchial washing	Neg	Pos	Pos	Pos	10	M.tuberculosis
16	Bronchial washing	Pos	Pos	Pos	Pos	10	Mycobacterium sp.
17	Bronchial washing	Pos	Pos	Pos	Neg	7	M.tuberculosis
18	Bronchial washing	Neg	Pos	Neg	Neg	12	M.chelonae
19	Biopsy	Neg	Neg	Pos	Neg
20	Biopsy	Pos	Pos	Pos	Neg	23
21	Fluid	Neg	Pos	Pos	Pos	23	M.tuberculosis
22	Fluid	Pos	Pos	Pos	Pos	14	M.triviale
23	Fluid	Pos	Neg	Pos	Pos
24	Fluid	Pos	Neg	Pos	Neg
25	Fluid	Pos	Pos	Pos	Pos	4	M.tuberculosis
26	Pus	Pos	Pos	Pos	Pos		M.tuberculosis

ND = not done.