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

Ann Lab Med. 2019 Mar;39(2):176-182. doi: 10.3343/alm.2019.39.2.176.

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: AmpliSens Pneumocystis jirovecii (carinii)-FRT PCR; Performance; Pneumocystis jirovecii; Pneumocystis pneumonia; Real-time PCR; RealStar Pneumocystis jirovecii PCR.

Publication types

  • Comparative Study

MeSH terms

  • Bronchoalveolar Lavage Fluid / microbiology
  • DNA, Bacterial / genetics
  • DNA, Bacterial / metabolism
  • Diagnostic Errors
  • Humans
  • Immunocompromised Host
  • Pneumocystis Infections / diagnosis*
  • Pneumocystis Infections / microbiology
  • Pneumocystis carinii / genetics*
  • Pneumocystis carinii / isolation & purification
  • Reagent Kits, Diagnostic
  • Real-Time Polymerase Chain Reaction / methods*
  • Respiratory Tract Diseases / diagnosis
  • Respiratory Tract Diseases / microbiology
  • Sputum / microbiology

Substances

  • DNA, Bacterial
  • Reagent Kits, Diagnostic