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Evaluation of two commercial amplification assays for detection ofMycobacterium tuberculosis complex in respiratory specimens

Bewertung zweier kommerzieller Amplifikationsassays für den Nachweis vonMycobacterium tuberculosis complex in Proben aus den Atemwegen

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Summary

To evaluate the usefulness of two standardized commercially available amplification assays for the detection ofMycobacterium tuberculosis: Amplicor® test (Roche) and MTD-Amplified direct test (Gen-Probe) a total of 281 respiratory specimens from 198 patients with symptoms of pulmonary diseases were examined and compared with conventional methods. Fifty-seven specimens were positive and 218 negative by both amplification assays. Three specimens were reactive by Amplicor® only, and three by MTD only. In comparison with culture, the sensitivity, specificity, positive predictive value and negative predictive value were 96.0, 94.8, 80.0, and 99.1%, respectively, for the Amplicor® test; the corresponding values were 94.0, 94.4, 78.3, and 98.6%, respectively, for the MTD. However, when 28 specimens from 14 patients on antituberculous therapy were excluded the improvement in PPV and specificity of both assays was obtained. In conclusion, both commercially available amplification tests are almost equally sensitive and specific and are suitable for the implementation in daily routine work in the specialized clinical laboratories.

Zusammenfassung

Um die Brauchbarkeit zweier standardisierter, kommerziell erhältlicher Amplifikationsassays für den Nachweis vonMycobacterium tuberculosis (Amplicor® Test (Roche und MTD Amplified Direct Test (Gen-Probe) zu beurteilen, wurden insgesamt 281 Proben aus den Atemwegen von 198 Patienten mit Symptomen einer Lungenerkrankung vergleichend mit konventionellen Methoden untersucht. 57 Proben waren positiv und 218 in beiden Amplifikationsassays negativ. Drei Proben waren nur mit Amplicor® positiv, drei nur mit MTD. Im Vergleich zur Kultur ergab sich eine Sensitivtät von 96,0%, Spezifität von 94,8%, ein positiver prädiktiver Wert von 80,0% und ein negativer prädikativer Wert von 99,1% für den Amplicor® Test. Die entsprechenden Werte für den MTD-Test sind 94,0, 94,4, 78,3 und 98,6%. Wenn man jedoch 28 Proben von 14 Patienten, die unter tuberkulostatischer Therapie standen, ausschließt, erhöhen sich der positive prädiktive Wert und die Spezifität bei beiden Testsystemen. Es folgt, daß beide kommerziell erhältlichen Amplifikationstests an Sensitivität und Spezifität nahezu gleich sind und sich für die Anwendung in der täglichen Routinearbeit in klinischen Speziallabors eignen.

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Authors and Affiliations

  1. Institute for Respiratory Diseases, 64204, Golnik

    Manca Žolnir-Dovč Dipl.-Biol

  2. Medical Faculty of Ljubljana, Institute of Microbiology, Zaloška 4, 61105, Ljubljana, Slovenia

    M. Poljak M. D., Katja Seme M. D. & Tatjana Avšič-Županc Ph. D.

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  1. Manca Žolnir-Dovč Dipl.-Biol
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  2. Alenka Rus M. Sc.
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  3. M. Poljak M. D.
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  4. Katja Seme M. D.
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  5. Tatjana Avšič-Županc Ph. D.
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Žolnir-Dovč, M., Rus, A., Poljak, M. et al. Evaluation of two commercial amplification assays for detection ofMycobacterium tuberculosis complex in respiratory specimens. Infection 23, 216–221 (1995). https://doi.org/10.1007/BF01781200

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