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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.

Publication ,  Journal Article
Hauser, PM; Bille, J; Lass-Flörl, C; Geltner, C; Feldmesser, M; Levi, M; Patel, H; Muggia, V; Alexander, B; Hughes, M; Follett, SA; Cui, X ...
Published in: J Clin Microbiol
May 2011

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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Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

May 2011

Volume

49

Issue

5

Start / End Page

1872 / 1878

Location

United States

Related Subject Headings

  • Sensitivity and Specificity
  • Polymerase Chain Reaction
  • Pneumonia, Pneumocystis
  • Pneumocystis carinii
  • Mycology
  • Molecular Diagnostic Techniques
  • Middle Aged
  • Microbiology
  • Male
  • Immunocompromised Host
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hauser, P. M., Bille, J., Lass-Flörl, C., Geltner, C., Feldmesser, M., Levi, M., … Denning, D. W. (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. J Clin Microbiol, 49(5), 1872–1878. https://doi.org/10.1128/JCM.02390-10
Hauser, Philippe M., Jacques Bille, Cornelia Lass-Flörl, Christian Geltner, Marta Feldmesser, Michael Levi, Hitesh Patel, et al. “Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay.J Clin Microbiol 49, no. 5 (May 2011): 1872–78. https://doi.org/10.1128/JCM.02390-10.
Hauser PM, Bille J, Lass-Flörl C, Geltner C, Feldmesser M, Levi M, et al. Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay. J Clin Microbiol. 2011 May;49(5):1872–8.
Hauser, Philippe M., et al. “Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay.J Clin Microbiol, vol. 49, no. 5, May 2011, pp. 1872–78. Pubmed, doi:10.1128/JCM.02390-10.
Hauser PM, Bille J, Lass-Flörl C, Geltner C, Feldmesser M, Levi M, Patel H, Muggia V, Alexander B, Hughes M, Follett SA, Cui X, Leung F, Morgan G, Moody A, Perlin DS, Denning DW. Multicenter, prospective clinical evaluation of respiratory samples from subjects at risk for Pneumocystis jirovecii infection by use of a commercial real-time PCR assay. J Clin Microbiol. 2011 May;49(5):1872–1878.

Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

May 2011

Volume

49

Issue

5

Start / End Page

1872 / 1878

Location

United States

Related Subject Headings

  • Sensitivity and Specificity
  • Polymerase Chain Reaction
  • Pneumonia, Pneumocystis
  • Pneumocystis carinii
  • Mycology
  • Molecular Diagnostic Techniques
  • Middle Aged
  • Microbiology
  • Male
  • Immunocompromised Host