Abstract
The gold standard for diagnosing pulmonary Mycobacterium tuberculosis (TB) is the detection of tubercle bacillus in patient sputum samples. However, current methods either require long waiting times to culture the bacteria or have a risk of getting false-positive results due to cross-contamination. In this study, a method to detect tubercle bacillus based on the molecular typing technique is presented. This method can detect genetic units, variable number of tandem repeat (VNTR), which are the characteristic of tuberculosis (TB), and performs quality control using a mathematical model, ensuring the reliability of the results. Compared to other methods, the proposed method was able to process and diagnose a large volume of samples in a run time of six hours, with high sensitivity and specificity. Our method is also in the pipeline for implementation in clinical testing. Reliable and confirmed results are stored into a database, and these data are used to further refine the model. As the volume of data processed from reliable samples increases, the diagnostic power of the model improves. In addition to improving the quality control scheme, the collected data can be also used to support other TB research, such as that regarding the evolution of the tubercle bacillus.
Highlights
In 2016, there were an estimated 10.4 million (95% uncertainty interval 8·8–12·2) new incident cases of Mycobacterium tuberculosis (MTB) worldwide
The aforementioned mycobacterial interspersed repetitive units (MIRUs)-variable number of tandem repeat (VNTR) loci were used as the characteristics of different TB subtypes [25], and MTUB21, MTUB04, QUB-18, QUB-26, QUB-11b, MIRU31, MIRU10, and MIRU26 were used due to the fact that they can be amplified at the same temperature. e repeat counts for each locus were set as the identifiers of the corresponding sample in the form of a numerical array
The occurrence rate of any given array is 1/108, assuming even distribution of each locus with a maximum repeat count of 10. e frequency of repeat counts for each locus can be measured from the sample data. en, as it can be seen in Table 1, the prior probability of each array can be calculated from the total number of permutations, following formula (1)
Summary
In 2016, there were an estimated 10.4 million (95% uncertainty interval 8·8–12·2) new incident cases of Mycobacterium tuberculosis (MTB) worldwide. E smear test of the primary specimen is the usual method, while the most reliable method of confirming the presence of the tubercle bacillus in the patient’s specimen is culture. This requires a waiting period of 3 to 6 weeks [6, 7], which results in uncertain treatment status for suspected TB patients during this long process of diagnosis. TB bacteria can be difficult to cultivate, leading to low sensitivity of smear microscopy [8, 9] Other methods, such as polymerase chain reaction (PCR) and the immunological ones, require less time but may generate false-positive results due to cross-contamination [10]. Other methods, such as polymerase chain reaction (PCR) and the immunological ones, require less time but may generate false-positive results due to cross-contamination [10]. erefore, it is important for clinicians, before making a definitive diagnosis, to take
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