Pitfalls Associated With the Use of Molecular Diagnostic Panels in the Diagnosis of Cryptococcal Meningitis

O'Halloran, Jane A; Franklin, Alexander; Lainhart, William; Burnham, Carey‐Ann D.; Powderly, William G.; Dubberke, Erik R.

doi:10.1093/ofid/ofx242

Cited by 33 publications

(13 citation statements)

References 10 publications

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“…In present study, the bacterial/fungal detections presented three false-negative results (S. agalactiae, E. coli and C. neoforman/gatiii), and similar findings have been previously described 15,20,29,30 . Factors such as low antigens titers, high PCR crossing thresholds and cultures with growth < 100 CFU/mL are associated with disagreements that can be attributed to reagents degradation in a kit near to expiration date low fluorescence and incorrect melting signals 29,31 . The trueness analysis of results among all positive detections was not performed, and false positives are a possible scenario, fact that has been previously reported to CMV.…”

Section: Discussionsupporting

confidence: 91%

“…However, in present study, there were disagreements due to four positive samples by CrAg that were negative by FA-M/E, as has been previously reported. The explanation for this finding is that the patient can remain positive for years, even after the resolution of the infection 28,29 . A 100% sensitivity of FA-M/E for newly diagnosed cryptococcosis in an HIV-infected population has been reported 30 .…”

Section: Discussionmentioning

confidence: 99%

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Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellín, Colombia

Peñata

Mesa

Leal

et al. 2020

Rev. Inst. Med. trop. S. Paulo

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellín, Colombia

Peñata

Mesa

Leal

et al. 2020

Rev. Inst. Med. trop. S. Paulo

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“…A recent study from Uganda demonstrated the 100% sensitivity of the FilmArray cryptococcal assay using CSF (n ϭ 18) collected to establish an initial diagnosis of cryptococcal meningitis (21). However, false-negative FilmArray ME panel results for cryptococci have been reported in both the FilmArray ME panel package insert and a case report (22), especially in patients with a low burden of disease. Further studies are needed to better define the performance of the FilmArray ME panel for establishing an initial diagnosis of cryptococcal meningitis.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

et al. 2018

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Rapid and accurate laboratory tests are important for the timely diagnosis and treatment of central nervous system infections. The FilmArray meningitis/encephalitis (ME) panel (BioFire Diagnostics, Salt Lake City, UT) is an FDA-cleared, multiplex molecular panel that allows the detection of 14 pathogens (bacterial [ = 6], viral [ = 7], and fungal [ = 1] pathogens) from cerebrospinal fluid (CSF). In this study, we evaluated the performance characteristics of the FilmArray ME panel using clinical, residual CSF samples ( = 291) that tested positive by a routine method(s) (e.g., bacterial culture, individual real-time PCR assay) for a pathogen represented on the ME panel. Of note, a subset ( = 76) of the CSF specimens was collected during the prevaccine era and had been characterized as positive for a bacterial pathogen. The FilmArray ME panel demonstrated an overall percent positive agreement (PPA) of 97.5% (78/80) for bacterial pathogens, 90.1% (145/161) for viruses, and 52% (26/50) for Despite the low overall agreement (52%) between the ME panel and antigen testing for detection of, the percent positive agreement of the FilmArray assay for was 92.3% (12/13) when the results were compared directly to the results of routine fungal smear or culture. The FilmArray ME panel offers a rapid (∼60-min), syndrome-based approach for the detection of select meningitis and encephalitis pathogens.

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“…The origin of this false-positivity has been hypothesized to be contamination from medical laboratory scientists, individuals collecting samples or other clinical samples processed in the same location; however, this has not been scientifically proven. Second, Cryptococcal meningitis should still be diagnosed by antigen testing due to superior sensitivity of that method [33][34][35]. Third, detection of HHV-6 is common and of questionable clinical significance [36][37][38].…”

Section: Central Nervous System Infection Syndromic Panelsmentioning

confidence: 99%

Appropriate Use and Future Directions of Molecular Diagnostic Testing

Graf

Pancholi

2020

Curr Infect Dis Rep

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Purpose of Review Major technologic advances in two main areas of molecular infectious disease diagnostics have resulted in accelerated adoption or ordering, outpacing implementation, and clinical utility studies. Physicians must understand the limitations to and appropriate utilization of these technologies in order to provide cost-effective and well-informed care for their patients. Recent Findings Rapid molecular testing and, to a lesser degree, clinical metagenomics are now being routinely used in clinical practice. While these tests allow for a breadth of interrogation not possible with conventional microbiology, they pose new challenges for diagnostic and antimicrobial stewardship programs. This review will summarize the most recent literature on these two categories of technologic advances and discuss the few studies that have looked at utilization and stewardship approaches. This review also highlights the future directions for both of these technologies. Summary The appropriate utilization of rapid molecular testing and clinical metagenomics has not been well established. More studies are needed to assess their prospective impacts on patient management and antimicrobial stewardship efforts as the future state of infectious disease diagnostics will see continued expansion of these technologic advances.

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Pitfalls Associated With the Use of Molecular Diagnostic Panels in the Diagnosis of Cryptococcal Meningitis

Cited by 33 publications

References 10 publications

Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellín, Colombia

Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellín, Colombia

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

Appropriate Use and Future Directions of Molecular Diagnostic Testing

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