Application of the Roche Amplicor, Mycobacterium tuberculosis (PCR) test to specimens other than respiratory secretions

D'Amato, R F; Hochstein, Lisa; Colaninno, Peter M.; Scardamaglia, M; Kim, Kyungmee; Mastellone, Anthony J.; Patel, Rajesh; Alkhuja, Samer; Tevere, Vincent J.; Miller, Albert

doi:10.1016/0732-8893(95)00256-1

Cited by 19 publications

(15 citation statements)

References 2 publications

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“…This will ensure early treatment to patients and prevent further transmission of disease. 13 However, further work is needed for improving sensitivity, specificity and reproducibility of this test and to make it more user friendly and cost effective.…”

Section: Resultsmentioning

confidence: 99%

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Comparison of the conventional diagnostic modalities, bactec culture and polymerase chain reaction test for diagnosis of tuberculosis

Negi¹,

Khan²,

Gupta³

et al. 2005

Indian J Med Microbiol

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Purpose: To evaluate the performance of 65 kDa antigen based PCR assay in clinical samples obtained from pulmonary and extrapulmonary cases of tuberculosis. Methods: One hundred and fifty six samples were processed for detection of Mycobacterium tuberculosis by ZN smear examination, LJ medium culture, BACTEC radiometric culture and PCR tests. Results: A significant difference was seen in the sensitivities of different tests, the figures being 74.4% for PCR test, 33.79% for ZN smear examination, 48.9% for LJ culture and 55.8% for BACTEC culture (P<0.05). However, there was no significant difference (P>0.05) as far as specificity of different tests was concerned. PCR test sensitivity in pulmonary and extrapulmonary clinical samples were 72.7% and 75.9% respectively and found to be significantly higher (P<0.05) when compared with those of other tests. The mean detection time for M.tuberculosis was 24.03 days by LJ medium culture, 12.89 days by BACTEC culture and less than one day by PCR test. Conclusions: PCR is a rapid and sensitive method for the early diagnosis of pulmonary and extrapulmonary tuberculosis.

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Section: Resultsmentioning

confidence: 99%

“…12 PCR test was also shown to be reasonably sensitive (75.9%) in diagnosis of extrapulmonary TB. [13][14][15] To conclude, molecular diagnosis of tuberculosis by PCR has a great potential to improve the clinicians' ability to diagnose tuberculosis. This will ensure early treatment to patients and prevent further transmission of disease.…”

Section: Resultsmentioning

confidence: 99%

Comparison of the conventional diagnostic modalities, bactec culture and polymerase chain reaction test for diagnosis of tuberculosis

Negi¹,

Khan²,

Gupta³

et al. 2005

Indian J Med Microbiol

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“…For lymph node tuberculosis, several authors have reported on in-house PCR assays with sensitivities between 68 and 100%, and specificities between 86 and 100%, respectively (16,21,23). Furthermore, the commercially available manual AMPLICOR PCR assay has been tested for extrapulmonary specimens with sensitivities ranging from 33.3% for smearnegative specimens to 85.7% for all specimens and specificities ranging from 93.1 to 100% (2,3,5,7,20). Automated PCR assays have the great advantage of processing a large number of samples in shorter amount of hands-on time (11).…”

Section: Patients and Samplesmentioning

confidence: 99%

Performance of an IS 6110 -Based PCR Assay and the COBAS AMPLICOR MTB PCR System for Detection of Mycobacterium tuberculosis Complex DNA in Human Lymph Node Samples

Rimek¹,

Tyagi

Kappe

2002

J Clin Microbiol

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We compared the performance of two PCR assays, an IS6110-based in-house protocol and the COBAS AMPLICOR MTB PCR (COBAS MTB) system, for the detection of Mycobacterium tuberculosis complex in 43 human lymph node samples from 40 patients. For the in-house PCR and the COBAS MTB assays, respectively, sensitivities were 87.5% versus 45.5% (P < 0.05), specificities were 100.0% versus 91.3% (P > 0.05), and inhibition rates were 4.8% versus 19.5% (P < 0.05). For the COBAS MTB system, additional N-acetyl-L-cysteineNaOH pretreatment of the samples changed neither the inhibition rate nor the sensitivity significantly.In Germany, tuberculous lymphadenitis is the most common form of extrapulmonary tuberculosis, comprising about 7 to 8% of all cases of tuberculosis (19). Rapid and accurate diagnosis is important for the effective treatment of lymph node tuberculosis. Conventional methods for detecting Mycobacterium tuberculosis complex include acid-fast staining and culture. The sensitivity of microscopy in lymph node samples of human immunodeficiency virus noninfected patients is low because of the low numbers of mycobacteria present. Furthermore, M. tuberculosis complex cannot be differentiated from mycobacteria other than tuberculosis (MOTT) by acid-fast staining. Culturing methods, including those in solid and liquid media, detect M. tuberculosis complex with reasonable sensitivity. They are a prerequisite for accurate identification to species level and susceptibility testing. However, culture requires several weeks for completion due to the slow growth of mycobacteria. Nucleic acid amplification assays have been developed for detecting M. tuberculosis complex directly from clinical specimens. However, commercially available automated methods like the COBAS AMPLICOR MTB PCR (COBAS MTB) assay (Roche Diagnostics) have been approved for pulmonary specimens only. Several authors have reported acceptable sensitivity and specificity rates for extrapulmonary specimens by the COBAS MTB assay (8, 18), but so far, lymph node samples have not been specifically examined.The purpose of this study was to evaluate the performance of the COBAS MTB assay for the detection of M. tuberculosis complex in lymph node samples and to compare it with an IS6110 in-house PCR assay. The results of acid-fast smear and culture and the clinical data of the patients were used for reference. Patients and samples.From January 1998 to December 1999, a total of 43 lymph node samples were surgically removed from 40 patients with possible lymph node tuberculosis. The specimens were sent in sterile tubes containing saline to the Hygiene Institute of the University of Heidelberg for the detection of mycobacteria. The patients were 18 females and 22 males with a median age of 25 years (range, 1 to 91 years).Processing of lymph node specimens. The specimens were carefully cut into 1-to 2-mm 3 pieces in sterile Petri dishes with sterile scalpels before being divided into three portions of equal size. The three aliquots were homogenized in 1 ml of sterile saline e...

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“…In a previous feasibility study, we established the specimen processing and test parameters for detecting M tuberculosis with the AMPLICOR system in specimens other than respirator; secretions. 9 The purpose of this investigation is to determine the clinical utility of the AMPLICOR MTB PCR test for the rapid diagnosis of disseminated and/or extrapulmonary TB using tissue and body fluid specimens other than respiratory secretions.…”

mentioning

confidence: 99%

Rapid Diagnosis of Tuberculosis in Various Biopsy and Body Fluid Specimens by the AMPLICOR Mycobacterium tuberculosis Polymerase Chain Reaction Test

Shah

Miller

Mastellone

et al. 1998

Chest

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Application of the Roche Amplicor, Mycobacterium tuberculosis (PCR) test to specimens other than respiratory secretions

Cited by 19 publications

References 2 publications

Comparison of the conventional diagnostic modalities, bactec culture and polymerase chain reaction test for diagnosis of tuberculosis

Comparison of the conventional diagnostic modalities, bactec culture and polymerase chain reaction test for diagnosis of tuberculosis

Performance of an IS 6110 -Based PCR Assay and the COBAS AMPLICOR MTB PCR System for Detection of Mycobacterium tuberculosis Complex DNA in Human Lymph Node Samples

Rapid Diagnosis of Tuberculosis in Various Biopsy and Body Fluid Specimens by the AMPLICOR Mycobacterium tuberculosis Polymerase Chain Reaction Test

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