Comparative Evaluation Between the RealStar Pneumocystis jirovecii PCR Kit and the AmpliSens Pneumocystis jirovecii ( carinii )-FRT PCR Kit for Detecting P. jirovecii in Non-HIV Immunocompromised Patients

• Published in: Annals of laboratory medicine Vol. 39; no. 2; pp. 176 - 182
• Main Authors: Huh, Hee Jae, Lim, Kyoung Ree, Ki, Chang-Seok, Huh, Kyungmin, Shim, Hyang Jin, Song, Dong Joon, Kim, Yae-Jean, Chung, Doo Ryeon, Lee, Nam Yong
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society for Laboratory Medicine 01.03.2019; 대한진단검사의학회
• Subjects: Original; 병리학; RealStar Pneumocystis jirovecii PCR; Real-time PCR; Performance; AmpliSens Pneumocystis jirovecii (carinii)-FRT PCR; Pneumocystis jirovecii; Pneumocystis pneumonia
• ISSN: 2234-3806; 2234-3814; 2234-3814
• DOI: 10.3343/alm.2019.39.2.176

Real-time PCR is more sensitive than microscopic examination for detecting . We compared the performance of two assays for detecting DNA: the RealStar PCR Kit 1.0 CE (Altona Diagnostics, Hamburg, Germany) and the AmpliSens ( )-FRT PCR kit (InterLabService Ltd., Moscow, Russia). We used 159 samples from the lower respiratory tract (112 bronchoalveolar lavage [BAL] fluid, 37 sputum, and 10 endotracheal aspirate [ETA] samples) of non-HIV immunocompromised patients. Nested PCR and sequencing were used to resolve discordant results. The performance of the two assays was evaluated according to clinical categories (clinical pneumonia [PCP], possible PCP, or unlikely PCP) based on clinical and radiological observations. The positive and negative percent agreement values were 100% (95% confidence interval [CI], 85.4-100%) and 96.6% (95% CI, 90.9-98.9%), respectively, and kappa was 0.92 (95% CI, 0.84-0.99). DNA load was significantly higher in the clinical PCP group than in the other groups ( <0.05). When stratified by sample type, the positive rate for BAL fluids from the clinical PCP group was 100% using either assay, whereas the positive rate for sputum/ETA samples was only 20%. The two assays showed similar diagnostic performance and detected low burden in BAL fluids. Both assays may be useful as routine methods for detecting DNA in a clinical laboratory setting, though their results should be interpreted considering sample type.