{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:06:06Z","timestamp":1753877166416,"version":"3.41.2"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T00:00:00Z","timestamp":1639180800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,1,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:label\/>\n                  <jats:p>Pneumocystis jirovecii (Pj) is a fungal pathogen that can cause severe and potential fatal pneumonia (Pneumocystis pneumonia, PCP) in immunocompromised patients. Microbiological diagnosis is necessary to confirm PCP, for which mainly real-time PCR assays are used by detecting Pj from bronchoalveolar lavage (BAL) specimens. In this study, we evaluate the performance of the CE-IVD PneumoGenius\u00ae assay and CE-IVD RealStar\u00ae Pneumocystis jirovecii PCR assay in comparison to the lab developed test (LDT) that is used in routine diagnostics. Comparison was done by including 100 BAL specimens: 25 retrospective specimens, selected based on results obtained with LDT (15 positive\/10 negative), and 75 prospectively collected specimens. LDT (targeting MSG) was performed according to local procedures and the PneumoGenius\u00ae (targeting mtLSU and DHPS fas) and RealStar\u00ae assays (targeting mtLSU) according to the manufacturer's instructions. Combining results of retrospective and prospective analysis, sensitivity was 69.7, 100 and 100% for the LDT, PneumoGenius\u00ae and RealStar\u00ae, respectively. Specificity was 100% for LDT and Pneumogenius\u00ae, whereas RealStar\u00ae showed a specificity of 97%. Correlation of fungal loads found with the PneumoGenius\u00ae and RealStar\u00ae assays was high (R2: 0.98). The PneumoGenius\u00ae and RealStar\u00ae assays performed comparable, and both showed high sensitivity in comparison to the LDT. For optimal diagnosis of PCP, the LDT has to be replaced by another, more sensitive assay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Lay summary<\/jats:title>\n                  <jats:p>In this study, we evaluated the performance of two commercially available CE-IVD cleared real-time PCR assays to detect Pneumocystis jirovecii in comparison to the lab-developed test as used in routine diagnostics. Performance of the CE-IVD real-time PCR assay was superior to the lab-developed test.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mmy\/myab080","type":"journal-article","created":{"date-parts":[[2021,12,9]],"date-time":"2021-12-09T12:43:11Z","timestamp":1639053791000},"source":"Crossref","is-referenced-by-count":4,"title":["Comparison of the PneumoGenius\u00ae and RealStar\u00ae <i>Pneumocystis jirovecii<\/i> PCR CE-IVD assays with a lab developed test for the detection of <i>Pneumocystis jirovecii<\/i>"],"prefix":"10.1093","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4203-3858","authenticated-orcid":false,"given":"Roel H T","family":"Nijhuis","sequence":"first","affiliation":[{"name":"Laboratory for Medical Microbiology and Medical Immunology, Meander Medical Center, 3813 TZ, Amersfoort, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peggy C R","family":"Godschalk","sequence":"additional","affiliation":[{"name":"Laboratory for Medical Microbiology and Medical Immunology, Meander Medical Center, 3813 TZ, Amersfoort, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorike H I","family":"Smink","sequence":"additional","affiliation":[{"name":"Laboratory for Medical Microbiology and Medical Immunology, Meander Medical Center, 3813 TZ, Amersfoort, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cindy","family":"van\u00a0der\u00a0Zee","sequence":"additional","affiliation":[{"name":"Laboratory for Medical Microbiology and Immunology, St. Antonius Hospital, 3435 CM, Nieuwegein, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik J","family":"van\u00a0Hannen","sequence":"additional","affiliation":[{"name":"Laboratory for Medical Microbiology and Immunology, St. Antonius Hospital, 3435 CM, Nieuwegein, The 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