Ann Lab Med 2019; 39(2): 176-182  https://doi.org/10.3343/alm.2019.39.2.176
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
Hee Jae Huh, M.D.1*, Kyoung Ree Lim, M.D.2*, Chang-Seok Ki, M.D.3, Kyungmin Huh, M.D.2, Hyang Jin Shim, M.T.4, Dong Joon Song, M.T.1, Yae-Jean Kim, M.D.5, Doo Ryeon Chung, M.D.2,6, and Nam Yong Lee, M.D.1
1Department of Laboratory Medicine and Genetics and 2Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; 3Green Cross Genome, Yongin, Korea; 4Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea; 5Division of Infectious Diseases, Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; 6Center for Infection Prevention and Control, Samsung Medical Center, Seoul, Korea
Corresponding author: Nam Yong Lee, M.D. https://orcid.org/0000-0003-3688-0145
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea
Tel: +82-2-3410-2706
Fax: +82-2-3410-2719
E-mail: micro.lee@samsung.com
*These authors equally contributed to this study.
Received: March 20, 2018; Revised: June 12, 2018; Accepted: October 17, 2018; Published online: March 1, 2019.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Real-time PCR is more sensitive than microscopic examination for detecting Pneumocystis jirovecii. We compared the performance of two assays for detecting P. jirovecii DNA: the RealStar Pneumocystis jirovecii PCR Kit 1.0 CE (Altona Diagnostics, Hamburg, Germany) and the AmpliSens Pneumocystis jirovecii (carinii)-FRT PCR kit (InterLabService Ltd., Moscow, Russia).
Methods: 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 Pneumocystis pneumonia [PCP], possible PCP, or unlikely PCP) based on clinical and radiological observations.
Results: 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). P. jirovecii DNA load was significantly higher in the clinical PCP group than in the other groups (P<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%.
Conclusions: The two assays showed similar diagnostic performance and detected low P. jirovecii burden in BAL fluids. Both assays may be useful as routine methods for detecting P. jirovecii DNA in a clinical laboratory setting, though their results should be interpreted considering sample type.
Keywords: Pneumocystis jirovecii, Pneumocystis pneumonia, Real-time PCR, RealStar Pneumocystis jirovecii PCR, AmpliSens Pneumocystis jirovecii (carinii)-FRT PCR, Performance



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