Multicenter, Prospective Clinical Evaluation of Respiratory Samples from Subjects at Risk for Pneumocystis jirovecii Infection by Use of a Commercial Real-Time PCR Assay

被引:66
作者
Hauser, Philippe M. [2 ,3 ]
Bille, Jacques [2 ,3 ]
Lass-Floerl, Cornelia [4 ]
Geltner, Christian [5 ]
Feldmesser, Marta [6 ]
Levi, Michael [7 ]
Patel, Hitesh [7 ]
Muggia, Victoria [8 ]
Alexander, Barbara [9 ]
Hughes, Martin [10 ]
Follett, Sarah A. [10 ]
Cui, Xiaohui [10 ]
Leung, Flora [10 ]
Morgan, Gillian [10 ]
Moody, Adrian [10 ]
Perlin, David S. [11 ]
Denning, David W. [1 ,10 ,12 ,13 ]
机构
[1] Univ S Manchester Hosp, Educ & Res Ctr, Manchester M23 9LT, Lancs, England
[2] CHU Vaudois, CH-1011 Lausanne, Switzerland
[3] Univ Lausanne, Lausanne, Switzerland
[4] Med Univ Innsbruck, Dept Hyg Mikrobiol & Sozalmed, Innsbruck, Austria
[5] Landeskrankenhaus Natters, Natters, Austria
[6] Montefiore Med Ctr, Albert Einstein Coll Med, Bronx, NY 10467 USA
[7] Montefiore Med Ctr, Dept Pathol, Bronx, NY 10467 USA
[8] Montefiore Med Ctr, Dept Med, Bronx, NY 10467 USA
[9] Duke Univ, Sch Med, Durham, NC USA
[10] Myconostica Ltd, Manchester, Lancs, England
[11] New Jersey Med Sch UMDNJ, Publ Hlth Res Inst, Newark, NJ USA
[12] Univ Manchester, Manchester, Lancs, England
[13] Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England
基金
英国医学研究理事会; 英国惠康基金;
关键词
BRONCHOALVEOLAR LAVAGE FLUID; POLYMERASE-CHAIN-REACTION; IMMUNODEFICIENCY-VIRUS-INFECTION; CARINII-PNEUMONIA; DNA AMPLIFICATION; FUNGAL-INFECTIONS; INDUCED SPUTUM; DIAGNOSIS; SPECIMENS; IDENTIFICATION;
D O I
10.1128/JCM.02390-10
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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/mu l 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.
引用
收藏
页码:1872 / 1878
页数:7
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