Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay

Philippe M. Hauser, Jacques Bille, Cornelia Lass-Flörl, Christian Geltner, Marta Feldmesser, Michael H. Levi, Hitesh Patel, Victoria Muggia, Barbara Alexander, Martin Hughes, Sarah A. Follett, Xiaohui Cui, Flora Leung, Gillian Morgan, Adrian Moody, David S. Perlin, David W. Denning

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Abstract

Pneumocystis jirovecii pneumonia (PCP) is a common opportunistic infection. Microscopic diagnosis, including diagnosis using the Merifluor-Pneumocystis direct fluorescent antigen (MP-DFA) test, has limitations. Real-time PCR may assist in diagnosis, but no commercially validated real-time PCR assay has been available to date. MycAssay Pneumocystis is a commercial assay that targets the P. jirovecii mitochondrial large subunit (analytical detection limit, ≤3.5 copies/μl of sample). A multicenter trial recruited 110 subjects: 54 with transplants (40 with lung transplants), 32 with nonmalignant conditions, 13 with leukemia, and 11 with solid tumors; 9 were HIV positive. A total of 110 respiratory samples (92% of which were bronchoalveolar lavage [BAL] specimens) were analyzed by PCR. Performance was characterized relative to investigator-determined clinical diagnosis of PCP (including local diagnostic tests), and PCR results were compared with MP-DFA test results for 83 subjects. Thirteen of 14 subjects with PCP and 9/96 without PCP (including 5 undergoing BAL surveillance after lung transplantation) had positive PCR results; sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) were 93%, 91%, 59%, and 99%, respectively. Fourteen of 83 subjects for whom PCR and MP-DFA test results were available had PCP; PCR sensitivity, specificity, PPV, and NPV were 93%, 90%, 65%, and 98%, respectively, and MP-DFA test sensitivity, specificity, PPV, and NPV were 93%, 100%, 100%, and 98%. Of the 9 PCR-positive subjects without PCP, 1 later developed PCP. The PCR diagnostic assay compares well with clinical diagnosis using nonmolecular methods. Additional positive results compared with the MP-DFA test may reflect low-level infection or colonization.

Original languageEnglish (US)
Pages (from-to)1872-1878
Number of pages7
JournalJournal of Clinical Microbiology
Volume49
Issue number5
DOIs
StatePublished - May 2011

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Pneumocystis Infections
Pneumocystis carinii
Pneumocystis
Pneumocystis Pneumonia
Real-Time Polymerase Chain Reaction
Polymerase Chain Reaction
Antigens
Bronchoalveolar Lavage
Sensitivity and Specificity
Transplants
Lung Transplantation
Opportunistic Infections
Routine Diagnostic Tests
Multicenter Studies
Limit of Detection
Leukemia
Research Personnel
HIV
Lung

ASJC Scopus subject areas

  • Microbiology (medical)

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Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay. / Hauser, Philippe M.; Bille, Jacques; Lass-Flörl, Cornelia; Geltner, Christian; Feldmesser, Marta; Levi, Michael H.; Patel, Hitesh; Muggia, Victoria; Alexander, Barbara; Hughes, Martin; Follett, Sarah A.; Cui, Xiaohui; Leung, Flora; Morgan, Gillian; Moody, Adrian; Perlin, David S.; Denning, David W.

In: Journal of Clinical Microbiology, Vol. 49, No. 5, 05.2011, p. 1872-1878.

Research output: Contribution to journalArticle

Hauser, PM, Bille, J, Lass-Flörl, C, Geltner, C, Feldmesser, M, Levi, MH, Patel, H, Muggia, V, Alexander, B, Hughes, M, Follett, SA, Cui, X, Leung, F, Morgan, G, Moody, A, Perlin, DS & Denning, DW 2011, 'Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay', Journal of Clinical Microbiology, vol. 49, no. 5, pp. 1872-1878. https://doi.org/10.1128/JCM.02390-10
Hauser, Philippe M. ; Bille, Jacques ; Lass-Flörl, Cornelia ; Geltner, Christian ; Feldmesser, Marta ; Levi, Michael H. ; Patel, Hitesh ; Muggia, Victoria ; Alexander, Barbara ; Hughes, Martin ; Follett, Sarah A. ; Cui, Xiaohui ; Leung, Flora ; Morgan, Gillian ; Moody, Adrian ; Perlin, David S. ; Denning, David W. / Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay. In: Journal of Clinical Microbiology. 2011 ; Vol. 49, No. 5. pp. 1872-1878.
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abstract = "Pneumocystis jirovecii pneumonia (PCP) is a common opportunistic infection. Microscopic diagnosis, including diagnosis using the Merifluor-Pneumocystis direct fluorescent antigen (MP-DFA) test, has limitations. Real-time PCR may assist in diagnosis, but no commercially validated real-time PCR assay has been available to date. MycAssay Pneumocystis is a commercial assay that targets the P. jirovecii mitochondrial large subunit (analytical detection limit, ≤3.5 copies/μl of sample). A multicenter trial recruited 110 subjects: 54 with transplants (40 with lung transplants), 32 with nonmalignant conditions, 13 with leukemia, and 11 with solid tumors; 9 were HIV positive. A total of 110 respiratory samples (92{\%} of which were bronchoalveolar lavage [BAL] specimens) were analyzed by PCR. Performance was characterized relative to investigator-determined clinical diagnosis of PCP (including local diagnostic tests), and PCR results were compared with MP-DFA test results for 83 subjects. Thirteen of 14 subjects with PCP and 9/96 without PCP (including 5 undergoing BAL surveillance after lung transplantation) had positive PCR results; sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) were 93{\%}, 91{\%}, 59{\%}, and 99{\%}, respectively. Fourteen of 83 subjects for whom PCR and MP-DFA test results were available had PCP; PCR sensitivity, specificity, PPV, and NPV were 93{\%}, 90{\%}, 65{\%}, and 98{\%}, respectively, and MP-DFA test sensitivity, specificity, PPV, and NPV were 93{\%}, 100{\%}, 100{\%}, and 98{\%}. Of the 9 PCR-positive subjects without PCP, 1 later developed PCP. The PCR diagnostic assay compares well with clinical diagnosis using nonmolecular methods. Additional positive results compared with the MP-DFA test may reflect low-level infection or colonization.",
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