[Evaluation of TB-beads assay utilizing the technique of magnetic beads--an innovative assay method for detection of acid fast bacilli].

ABSTRACT

The centrifuge method with the use of Semi-Alkalin Proteinase (SAP) and NALC-NaOH, recommended by the "2007 edition of the assay guideline for detection of Mycobacterium tuberculosis," has significantly contributed to improving the sensitivities and specificities of both smear and culture tests for detection of acid fast bacilli (AFB). However, this method poses some challenges in terms of its cumbersome and time-consuming assay protocol. "TB-beads (Kyokuto Pharmaceutical Industrial Co., Ltd.)" is a newly-developed method for detection of AFB utilizing magnetic beads. We evaluated the quality of this method in comparison with the centrifuge method, focusing on the results of smear and culture tests. This evaluation study was conducted using both 5 positive and 5 negative sputum samples. The sensitivity of TB-beads for fluorescent smear tests, conducted using "Acri-stain," was almost the same as that of the centrifuge method. One advantage of TB-beads, however, was that it was very convenient to practice microscopic observation due to the clear background of the smeared glass slides. The comparison of the contamination rates between the two methods showed that TB-beads suggested significantly lower contamination rates. The centrifuge method resulted in 50% and 60% of contamination rates for HK Semisolid Isolation Medium and BacT/ALERT MP, respectively. On the other hand, the contamination rates of TB-beads for both of the culture methods were only 10%. With regard to the 5 positive sputum samples, the comparison of the detection rates between the centrifuge and TB-Beads method was made utilizing Myco Acid, Ogawa K, and BacT/ALERT MP. The TB-Beads method suggested higher detection rates for Myco Acid and Ogawa K, while there were no significant differences between the two methods for BacT/ALERT MP (16-23 days). TB-beads is an easy method that allows to simplify the process of smear tests, and contributes to significantly reducing the contamination rate of culture tests. It also contributes to improving the sensitivity and detection rate of AFB testing. Furthermore, it does not require centrifugation. Ultimately, TB-beads is an innovative, safe, and convenient testing method for detection of AFB, which enables laboratory technicians to save time for routine work.