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A total of 1, 515 TB suspects were enrolled in this study; 52% of the suspects (n = 788) provided three sputum specimens; 47.9% (n = 725) provided two sputum specimens; 0.1% (n = 2) provided only one sputum specimen. As a result, 3, 816 sputum specimens were collected.
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ATB detection analysis was carried out via MTSS and CM in the 3, 816 specimens. The overall positive rate of MTSS was 27.96%, which was higher as compared with that of CM, which yielded an average positive rate of 26.83%. However, these differences were insignificant in both hospitals (P = 0.228 and P = 0.611) (Table 1).
Hospital MTSS (%) CM (%) χ2 P-Value Anhui Provincial Chest Hospital 20.95 (328/1, 566) 19.22 (301/1, 566) 1.45 0.228 Linyi People's Hospital 32.84 (739/2, 250) 32.13 (723/2, 250) 0.26 0.611 Total 27.96 (1, 067/3, 816) 26.83 (1, 024/3, 816) 1.218 0.27 Table 1. Comparison of AFB Detection Rate by MTSS and CM
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The overall concordance rate between MTSS and CM was 95.9% (3, 661/3, 816). MTSS detected more scanty slides and 2+ slides while CM reported more 1+ and 3+ slides. A total of 155 specimens had discrepant results between MTSS and CM. Among them, 99 slides were MTSS positive but CM negative, while 56 slides that were MTSS negative were reported as positive by CM (Table 2). Approximately 92% (23/25) of the MTSS negative, but CM positive specimens, in Linyi Hospital were found to be culture positive, and 45% (14/31) of MTSS negative, but CM positive specimens, in Anhui Hospital were culture positive (Table 3).
Hospital MTSS Scanty CM 1+ 2+ 3+ 4+ Negative Subtotal Anhui Provincial Chest Hospital Scanty 17 30 8 7 1 33 96 1+ 6 21 13 3 5 11 59 2+ 3 44 29 11 15 12 121 3+ 5 10 8 3 6 1 34 4+ 3 1 2 1 6 1 18 Negative 16 12 1 1 1 1, 207 1, 238 Subtotal 35 118 61 26 34 1, 265 1, 566 Linyi People's Hospital Scanty 12 48 12 4 0 26 102 1+ 8 66 39 16 9 7 145 2+ 2 77 83 94 38 8 302 3+ 0 7 26 47 18 0 98 4+ 0 3 12 31 46 0 92 Negative 8 15 1 1 0 1, 486 1, 511 Subtotal 30 216 173 193 111 1, 527 2, 250 Total Scanty 29 78 20 11 1 59 198 1+ 14 87 52 19 14 18 204 2+ 5 121 112 105 53 20 423 3+ 5 17 34 50 24 1 132 4+ 3 4 14 32 52 1 110 Negative 24 27 2 2 1 2, 693 2, 749 Total 65 334 234 219 145 2, 792 3, 816 Table 2. Comparison of Microscopy Results between MTSS and CM
Hospital Solid Culture Positive Negative Subtotal Anhui Provincial Chest Hospital MTSS positive, CM negative 25 33 58 MTSS negative, CM positive 14 17 31 Subtotal 39 50 89 Linyi People's Hospital MTSS positive, CM negative 29 12 41 MTSS negative, CM positive 23 2 25 Subtotal 52 14 66 Total MTSS positive, CM negative 54 45 99 MTSS negative, CM positive 37 19 56 Total 91 64 155 Table 3. Analysis of Discrepant Results between MTSS and CM
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Fifteen specimens were excluded from analysis due to culture contamination. In total, data from 3, 801 specimens were used for performance analysis. Compared to culture, the general sensitivity and specificity of MTSS was 78.9% and 93.9%, respectively. CM showed lower sensitivity (77.4%) but higher specificity (95.0%) as compared with those of MTSS. Although CM demonstrated higher positive predictive value of 86.9%, MTSS showed a better negative predictive value of 91.2% (Table 4).
Sites Sensitivity (%) Specificity (%) PPV (%) NPV (%) Anhui Provincial Chest Hospital Correct No./Total No. (%) 222/349 (63.6) 1, 105/1, 211 (91.2) 222/328 (67.7) 1, 105/1, 232 (89.7) 95% CI 58.6-68.7 89.7-92.8 62.6-72.7 88.0-91.4 Linyi People's Hospital MTSS Correct No./Total No. (%) 681/795 (85.7) 1, 391/1, 446 (96.2) 681/736 (92.5) 1, 391/1, 505 (92.4) 95% CI 83.2-88.1 95.2-97.2 90.6-94.4 91.1-93.8 Total Correct No./Total No. (%) 903/1, 144 (78.9) 2, 496/2, 657 (93.9) 903/1, 064 (84.9) 2, 496/2, 737 (91.2) 95% CI 76.6-81.3 93.0-94.8 82.7-87.0 90.1-92.3 Anhui Provincial Chest Hospital Correct No./Total No. (%) 211/349 (60.5) 1, 121/1, 211 (92.6) 211/301 (70.1) 1, 121/1, 259 (89.0) 95% CI 55.3-65.6 91.1-94.0 64.9-75.3 87.3-90.8 Linyi People's Hospital CM Correct No./Total No. (%) 675/795 (84.9) 1, 401/1, 446 (96.9) 675/720 (93.8) 1, 401/1, 521 (92.1) 95% CI 82.4-87.4 96.0-97.8 92.0-95.5 90.8-93.5 Total Correct No./Total No. (%) 886/1, 144 (77.4) 2, 523/2, 657 (95.0) 886/1, 020 (86.9) 2, 523/2, 781 (90.7) 95% CI 75.0-79.9 94.1-95.8 84.8-88.9 89.6-91.8 Note. PPV, positive predictive value; NPV, negative predictive value. Table 4. Diagnostic Performance of MTSS and CM for Detection of TB Compared to Culture Methods
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From a total of 200 slides, 195 received same results as the original diagnosis, resulting in an accordance rate of 97.5%. All of five discrepant slides were minor grade differences. No false positive or false negative result was observed.
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Six laboratory staffs completed questionnaires on the acceptability of the MTSS method. According to the survey, all staffs believed that the MTSS procedure was easier to perform, five (83%) individuals noted that the price of the MTSS test was expensive, and six (100%) individuals expressed that they would like to use MTSS instead of CM.