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Cited by 36Bacterial Identification and Susceptibility TestingBacterial Infections and VaccinesInfectious Encephalopathies and Encephalitis

Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis

Open access
Pfefferle, Susanne, Christner, Martin, Aepfelbacher, Martin, Lütgehetmann, Marc, Rohde, Holger·2020·BMC Infectious Diseases
DOI 10.1186/s12879-020-4904-4PMC PMC7036261

Published version of a preprint

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Abstract

Background: Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden. Methods: Over a period of 18 months we received 4623 CSF samples (2338 hospitalizations, 1601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N = 171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only ( n = 45), PCR only ( n = 20) or both methods ( n = 106). Results: 56/171 (32.75%) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57%), viral pathogens were detected in 27/56 (48.21%) and yeast DNA was detected in 1/56 (1.79%) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86%) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity = 96.30%, specificity =96.58%). Conclusion: The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.

AI snapshot

Written from the paper’s full text.

TL;DR

In a real-life 18-month implementation at a German university hospital, restricting FilmArray ME testing to 171/4623 CSF samples with high pretest probability yielded a 32.75% positivity rate and good concordance with reference methods (sensitivity 96.30%, specificity 96.58%). The authors conclude the assay is fast and reliable but requires experienced interpretation and cannot replace culture/antimicrobial susceptibility testing.

Key findings

  • Among 171 selected CSF samples, 56/171 (32.75%) were FilmArray ME positive; bacterial pathogens were detected in 30/56 (53.57%), viral pathogens in 27/56 (48.21%), and yeast in 1/56 (1.79%); double detection occurred in 2/56 samples.
  • 52/56 (92.86%) FilmArray ME positive results were confirmed by reference assays; sensitivity was 96.30%, specificity 96.58%, PPV 92.86%, and NPV 98.26%. Four FilmArray positives (S. pneumoniae, E. coli, S. agalactiae, HSV-1) were not confirmed, and two FilmArray negatives were positive by in-house PCR for S. pneumoniae and Parechovirus.
  • S. pneumoniae was the most frequent bacterial pathogen (17/30); rapid detection also included N. meningitidis (n=5), H. influenzae (n=2), and L. monocytogenes (n=3). Ten samples had pathogens not included in the panel detected by culture or PCR (Bacillus sp., CoNS, S. aureus, K. pneumoniae; BK virus, Streptococcus spp.).
  • The risk-assessment-driven selection strategy produced a higher positivity rate than comparator studies reporting under 15% (p < 0.0001) and a higher proportion of bacterial pathogens.

Methods

  • Prospective real-life implementation from September 2015 through February 2017 at a German university hospital; 4623 CSF samples were received (2338 hospitalizations, 1601 individuals). FilmArray ME was restricted to 171 samples with high pretest probability: Gram-stain abnormality (leukocytes and/or bacteria) or urgent clinician suspicion of infection.
  • FilmArray ME was performed per manufacturer instructions using 200 µl CSF. Reference methods were culture only (n=45), PCR only (n=20), or both (n=106); reference diagnostics included bacterial culture/Gram stain, laboratory-developed quantitative real-time PCRs, and SepsiTest-UMD for 16S/18S rRNA.
  • Main analysis compared FilmArray ME results with reference assays to calculate positivity rates, pathogen composition, and performance metrics (sensitivity, specificity, PPV, NPV).

Limitations

  • Stated: no sample randomization; the selection strategy may cause selection bias; selection was mainly based on Gram-stain abnormalities, which is not ideal for leukocyte detection; not all samples were tested by all comparator assays, so pathogens may have been overlooked; no clinical data were analyzed, so effects on patient outcome or antibiotic utilization remain unclear.
  • Evident from the text: this was a single-center real-life implementation; comparator methods varied by sample; discordant results included possible false positives/negatives and unclear HHV-6 relevance; no clinical outcome data were available to assess management impact.

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Registry

Crossref · 10.1186/s12879-020-4904-4

Cites

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Statistics

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Claims the paper makes

0 of 61 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    56/171 (32.75%) samples were FilmArray ME positive.

    “56/171 (32.75%) were FilmArray ME positive.”
    Quote in the paperSubstantial claim
  • Findingown data

    52/56 positive FilmArray ME results could be confirmed by the reference assays (sensitivity=96.30%, specificity=96.58%, PPV=92.86%).

    “52/56 positive FilmArray ME results could be confirmed by the reference assays (sensitivity = 96.30%, specificity = 96.58%, PPV = 92.86%).”
    Quote in the paperSubstantial claim
  • Findingown data

    For the three samples positive for bacterial pathogens E. coli, S. pneumoniae and S. agalactiae, primary culture showed no bacterial growth after incubation period.

    “For the three samples positive for bacterial pathogens E.coli, S. pneumonia and S. agalactiae, primary culture showed no bacterial growth after incubation period.”
    Quote in the paperNot a substantial claim
  • Findingown data

    S. pneumoniae (17/30) was the most frequent bacterial pathogen detected by the FilmArray ME assay.

    “S. pneumoniae (17/30) was the most frequent bacterial pathogen detected by the FilmArray ME assay.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.
  • Findingown data

    In 10 samples, pathogens not found by the FilmArray ME panel were detected by culture (Bacillus sp., CoNS, S. aureus, K. pneumoniae) or PCR (BK virus, Streptococcus spp.).

    “In 10 samples, pathogens not found by the FilmArray ME panel were detected by culture (Bacillus sp., CoNS, S. aureus, K. pneumoniae) or PCR (BK virus, Streptococcus spp.).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. 28
  • May combine two claims. 45

  • Classified as probably not a substantial claim. May combine two claims.

    Findingown data

    Of the 171 samples, 117 had abnormality in gram-stain (116 with leukocytes, one with bacteria seen without evidence for leukocytes) and 54 were selected because suspicion of infectious meningitis was communicated by clinicians.

    “Of those, n = 117 samples had abnormality in gram-stain (n = 116 samples with leukocytes, one samples with bacteria seen without evidence for leukocytes) and n = 54 samples were selected as suspicion of infectious meningitis was communicated by clinicians.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In four samples, potentially false positive results of FilmArray ME panel occurred, including three samples positive for bacterial pathogens by multiplex PCR that remained culture negative.

    “In four samples, potentially false positive results of FilmArray ME panel occurred, including three samples tested positive for bacterial pathogens by multiplex PCR that remained culture negative.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • Classified as probably not a substantial claim. May combine two claims.

    Findingown data

    Samples analyzed by FilmArray ME were also tested by reference methods: culture only (n=45), molecular analysis only (n=20), or both methods (n=106).

    “Samples analyzed by FilmArray ME were also tested by reference methods: culture only (n = 45), molecular analysis only (n = 20) or both methods (n = 106).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Leucocytes were seen in 122/147 (82.99%) samples, bacteria in 15/147 (10.20%) samples, and yeast in 1/147 (0.68%) of those samples.

    “Leucocytes were seen in 122/147 (82.99%) samples, bacteria in 15/147 (10.20%) samples and yeast in 1/147 (0.68%) of those samples.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Within the subset of samples selected upon request by clinicians (n=54), positive FilmArray ME results were obtained in 44/54 samples (positivity rate=22.22%, sensitivity=91.67%, specificity=97.62%).

    “Within the subset of samples selected upon request by clinicians, (n = 54), positive Film Array ME results were obtained in 44/54 samples (positivity rate = 22.22%, sensitivity = 91.67%, specificity = 97.62%).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Bacterial culture was performed in 2682 samples, molecular diagnostic in 1891 samples, and 50 samples were sent for serology.

    “In detail, bacterial culture was performed in n = 2682 samples, molecular diagnostic was performed in n = 1891 samples and n = 50 samples were sent for serology purpose.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In two samples, FilmArray analysis detected two pathogens (VZV and HHV-6, and H. influenzae and HHV-6, respectively).

    “In two samples, FilmArray analysis detected two pathogens (VZV and HHV-6, and H. influenzae and HHV-6, respectively).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    In the subset of 30 samples selected upon clinical request, 6/30 had positive gram stain (20.00%) and 25/30 had negative gram stain (83.33%).

    “6/30 samples of that subset had positive gram stain (20.00%), whereas 25/30 samples had negative gram stain (83.33%).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Presence of VZV (1.4 × 104 copies/ml) and H. influenzae was confirmed by specific real-time PCRs.

    “Presence of VZV (1.4 × 104 copies/ml) and H. influenzae was confirmed by specific real-time PCRs, but conventional assays were unable to detect HHV-6, and these results were thus regarded as false-positive.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Double detection occurred in two FilmArray ME positive samples.

    “Double detection occurred in two samples.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The overall positivity rate was 5.97%, with positive results in 137/2682 samples analyzed by culture (5.11%) and 139/1891 samples analyzed by molecular methods (7.35%).

    “The overall positivity rate was 5.97% with positive results in 137/2682 samples analyzed by culture (5.11%) and 139/1891 positive results in samples analyzed by molecular methods (7.35%).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Bacterial pathogens were detected in 30/56 (53.57%) and viral pathogens in 27/56 (48.21%) of FilmArray ME positive samples.

    “Bacterial pathogens were detected in 30/56 (53.57%) and viral pathogens were detected in 27/56 (48.21%) of positive samples.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Specific real-time PCR was performed in the two samples positive for S. pneumoniae and S. agalactiae, but no signal was obtained.

    “Specific real-time PCR was performed in the two samples positive for S. pneumoniae and S. agalactiae, but no signal was obtained.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Overall, gram stain was performed in 147/171 samples.

    “Overall, gram stain was performed in 147/171 samples.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Within the subset of samples selected for leucocytes seen in gram stain (n=116), positive FilmArray ME results were obtained in 44/116 samples (positivity rate 37.93%, sensitivity=99.45%, specificity=10.96%).

    “Within the subset of samples selected for leucocytes seen in gram stain (n = 116), positive Film Array ME results were obtained in 44/116 samples (positivity rate 37.93%, sensitivity = 99.45%, specificity = 10.96%).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In 24/54 (44.44%) of samples selected upon clinical request, gram stain and primary bacterial culture were not performed because suspicion for viral infection was communicated.

    “Of note, in 24/54(44.44%) of samples selected upon clinical request, gram stain and primary bacterial culture was not performed as suspicion for viral infection was communicated.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    No bacterial 16S-rRNA was detected in the sample positive for S. pneumoniae in SepsiTest®-UMD (Molzym).

    “Also, no bacterial 16S-rRNA was detected in the sample positive for S. pneumoniae in SepsiTest®-UMD (Molzym).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Neither the laboratory developed real-time PCR assay nor a commercially available real-time PCR assay yielded a positive result for the HSV-1 FilmArray positive sample.

    “Neither our laboratory developed real-time PCR assay, nor a commercially available real-time PCR assay yielded a positive result (see Table 1 for assay details).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Over a period of 18 months, the laboratory received 4623 CSF samples (2338 hospitalizations, 1601 individuals).

    “Over a period of 18 months we received a total of n = 4623 CSF samples (2338 hospitalizations, 1601 individuals), including samples sent for both molecular diagnostic and bacterial culture as well as samples sent only for either purpose.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Within the subset of samples selected for positive gram stain, organisms were seen in 16/117 samples (bacteria in 15/117 (12.82%), yeast in 1/117 (0.85%, positivity rate=13.63%, sensitivity=22.73%, specificity=91.78%).

    “Organisms have been seen in 16/117 samples selected for positive gram stain (bacteria in 15/117 samples (12.82%), yeast in 1/117 samples (0.85%, positivity rate = 13.63%, sensitivity = 22.73%, specificity = 91.78%).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In this study, pathogens not included in the panel were detected by comparator assays in 10 samples: Bacillus sp., CoNS, S. aureus, and K. pneumoniae grew on culture media, whereas BK virus and Streptococcus spp. were detected by PCR.

    “In our study, we detected pathogens that are not included in the panel by comparator assays in 10 samples: Bacillus sp., CoNS, S. aureus, and K. pneumoniae grew on culture media, whereas BK virus and Streptococcus spp. were detected by PCR.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • May combine two claims.

    Premisecitation

    In the multicenter evaluation study, N. meningitides and L. monocytogenes were detected in none of the samples.

    “Most notably, N. meningitides, a worldwide leading meningitis pathogen, and L. monocytogenes detected in none of the samples [6].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [6] Leber AL, et al. Multicenter evaluation of BioFire FilmArray meningitis/encephalitis panel for detection of Bacteria, viruses, and yeast in cerebrospinal fluid specimens. J Clin Microbiol. 2016;54(9):2251–61. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Infectious meningitis is a serious threat with high morbidity and mortality rates.

    “Infectious meningitis is a serious threat with high morbidity and mortality rates [1–4].”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [1] Lee BE, Davies HD. Aseptic meningitis. Curr Opin Infect Dis. 2007;20(3):272–7. source

      Not checked in the free run.

    • cites [2] Costerus JM, et al. Community-acquired bacterial meningitis. Curr Opin Infect Dis. 2017;30(1):135–41. source

      Not checked in the free run.

    • cites [3] McGill F, Griffiths MJ, Solomon T. Viral meningitis: current issues in diagnosis and treatment. Curr Opin Infect Dis. 2017;30(2):248–56. source

      Not checked in the free run.

    • cites [4] Almuhayawi M, et al. Identification of microorganisms by FilmArray and matrix-assisted laser desorption ionization-time of flight mass spectrometry prior to positivity in the blood culture system. J Clin Microbiol. 2014;52(9):3230–6. source

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    In bacterial meningitis, patient outcome can be optimized through immediate antibiotic treatment, and fast and reliable diagnostic can be crucial.

    “In bacterial meningitis, patient outcome can be optimized through immediate antibiotic treatment, thus fast and reliable diagnostic can be crucial [2, 5].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [2] Costerus JM, et al. Community-acquired bacterial meningitis. Curr Opin Infect Dis. 2017;30(1):135–41. source

      Not checked in the free run.

    • cites [5] Fitch MT, van de Beek D. Emergency diagnosis and treatment of adult meningitis. Lancet Infect Dis. 2007;7(3):191–200. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In comparator studies, viruses were detected most frequently (83.8-54.46% of positive samples) followed by bacteria (37.62-15.21% of positive samples, p < 0.0001).

    “In contrast, in the comparator studies viruses were detected most frequently (83.8 -54.46% of positive samples) followed by bacteria (37.62 - 15.21% of positive samples, p < 0.0001).”
    Quote in the paperNot a substantial claim0 of 4 sources checked
    • cites [6] Leber AL, et al. Multicenter evaluation of BioFire FilmArray meningitis/encephalitis panel for detection of Bacteria, viruses, and yeast in cerebrospinal fluid specimens. J Clin Microbiol. 2016;54(9):2251–61. source

      Not checked in the free run.

    • cites [7] Tarai B, Das P. FilmArray(R) meningitis/encephalitis (ME) panel, a rapid molecular platform for diagnosis of CNS infections in a tertiary care hospital in North India: one-and-half-year review. Neurol Sci. 2019;40(1):81–8. source

      Not checked in the free run.

    • cites [32] Radmard S, et al. Clinical utilization of the FilmArray meningitis/encephalitis (ME) multiplex polymerase chain reaction (PCR) assay. Front Neurol. 2019;10:281. source

      Not checked in the free run.

    • cites [33] Naccache SN, et al. One Year in the Life of a Rapid Syndromic Panel for Meningitis/Encephalitis: a Pediatric Tertiary Care Facility’s Experience. J Clin Microbiol. 2018;56(5):e01940–17. source

      Not checked in the free run.

    • Rests on an assumption: The positivity rates and pathogen distributions in other published studies are comparable to the present setting.

  • May combine two claims.

    Interpretationown data

    The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis.

    “The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    In the multicenter evaluation study, n=1560 samples were analyzed by FilmArray ME and the overall positivity rate was 8.7%; bacteria were detected in 16.2% of positive samples, viruses in 83.8%, and yeast in 3.7%.

    “b In the multicenter evaluation study [6] n = 1560 samples were analyzed by Film Array ME and the overall positivity rate was 8.7%. Bacteria were detected in 16.2% of positive samples, viruses in 83.8% of positive samples and yeast in 3.7% of positive samples.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [6] Leber AL, et al. Multicenter evaluation of BioFire FilmArray meningitis/encephalitis panel for detection of Bacteria, viruses, and yeast in cerebrospinal fluid specimens. J Clin Microbiol. 2016;54(9):2251–61. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The remaining uncertainty in interpretation of results is a key point in the controversial discussion concerning the clinical utility of syndromic testing approaches in infectious meningitis/encephalitis.

    “Aside from the inarguably higher costs of multiplex molecular detection methods compared to standard laboratory procedures like bacterial culture, the remaining uncertainty in interpretation of results is a key point in the controversial discussion concerning the clinical utility of such syndromic testing approaches in infectious meningitis/encephalitis [15].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Dien Bard J, Alby K. Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory. J Clin Microbiol. 2018;56(4):e00018. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Tarai et al. reported a positivity rate of 10.4% in n=969 CSF samples analyzed; bacteria were detected in 37.2%, viruses in 54.46%, and yeast in 6.93% of positive samples.

    “c Tarai et al. [7] reported a positivity rate of 10.4% in n = 969 CSF samples analyzed. In their study, bacteria were detected in 37.2%, viruses in 54.46% and yeast in 6.93% of positive samples, respectively.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] Tarai B, Das P. FilmArray(R) meningitis/encephalitis (ME) panel, a rapid molecular platform for diagnosis of CNS infections in a tertiary care hospital in North India: one-and-half-year review. Neurol Sci. 2019;40(1):81–8. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Studies on prospective clinical specimens indicating the right patient population or determining the ideal testing approach are missing.

    “Yet, studies on prospective clinical specimens indicating the right patient population or determining the ideal testing approach are missing [15].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] Dien Bard J, Alby K. Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory. J Clin Microbiol. 2018;56(4):e00018. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Both false positive and false negative detections have been reported throughout studies of FilmArray ME.

    “Admittedly, both false positive and false negative detections have been reported throughout the studies, with one example of an erroneously diagnosed HSV-1 meningitis in a patient with an underlying tuberculous meningitis [14] and one study indicating a potential of missing viral infections in a pediatric cohort [10].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [14] Gomez CA, et al. Delayed Diagnosis of Tuberculous Meningitis Misdiagnosed as Herpes Simplex Virus-1 Encephalitis With the FilmArray Syndromic Polymerase Chain Reaction Panel. Open Forum Infect Dis. 2017;4(1):ofw245. source

      Not checked in the free run.

    • cites [10] Graf EH, Farquharson MV, Cardenas AM. Comparative evaluation of the FilmArray meningitis/encephalitis molecular panel in a pediatric population. Diagn Microbiol Infect Dis. 2017;87(1):92–4. source

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationown data

    Correlation of FilmArray ME test results and underlying clinical symptoms requires experienced users and awareness of potentially false negative or false positive results.

    “However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Naccache et al. observed an overall positivity rate of 13.43% of n=253 samples tested, with bacterial pathogens in 26.47% and viral pathogens in 73.52%; no yeast were found.

    “e In a prospective study monitoring unrestricted physician ordered testing, Naccache et al. observed an overall positivity rate of 13.43% of n = 253 samples tested, with bacterial pathogens in 26.47% and viral pathogens in 73.52%. No yeast were found in that study”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The positivity rate of 32% in this study is higher than in other published studies and substantially higher than the multicenter evaluation study and three other studies that reported positivity rates under 15% (p < 0.0001).

    “which is higher than in other published studies [6, 7, 9–12, 34–38] and substantially higher compared to the multicenter evaluation study [6] and three other studies [7, 32, 33], that reported positivity rates of under 15% (p < 0.0001).”
    Quote in the paperSubstantial claim0 of 10 sources checked
    • cites [6] Leber AL, et al. Multicenter evaluation of BioFire FilmArray meningitis/encephalitis panel for detection of Bacteria, viruses, and yeast in cerebrospinal fluid specimens. J Clin Microbiol. 2016;54(9):2251–61. source

      Not checked in the free run.

    • cites [7] Tarai B, Das P. FilmArray(R) meningitis/encephalitis (ME) panel, a rapid molecular platform for diagnosis of CNS infections in a tertiary care hospital in North India: one-and-half-year review. Neurol Sci. 2019;40(1):81–8. source

      Not checked in the free run.

    • cites [9] Launes C, et al. Utility of FilmArray meningitis/encephalitis panel during outbreak of brainstem encephalitis caused by Enterovirus in Catalonia in 2016. J Clin Microbiol. 2017;55(1):336–8. source

      Not checked in the free run.

    • cites [10] Graf EH, Farquharson MV, Cardenas AM. Comparative evaluation of the FilmArray meningitis/encephalitis molecular panel in a pediatric population. Diagn Microbiol Infect Dis. 2017;87(1):92–4. source

      Not checked in the free run.

    • cites [11] Arora HS, et al. Enhanced identification of group B streptococcus and Escherichia Coli in young infants with meningitis using the Biofire Filmarray meningitis/encephalitis panel. Pediatr Infect Dis J. 2017;36(7):685–7. source

      Not checked in the free run.

    • cites [12] Wootton SH, et al. Enhancing pathogen identification in patients with meningitis and a negative gram stain using the BioFire FilmArray((R)) meningitis/encephalitis panel. Ann Clin Microbiol Antimicrob. 2016;15:26. source

      Not checked in the free run.

    • cites [34] Hanson KE, et al. Preclinical assessment of a fully automated multiplex PCR panel for detection of central nervous system pathogens. J Clin Microbiol. 2016;54(3):785–7. source

      Not checked in the free run.

    • cites [35] Messacar K, et al. Potential clinical impact of the film array meningitis encephalitis panel in children with suspected central nervous system infections. Diagn Microbiol Infect Dis. 2016;86(1):118–20. source

      Not checked in the free run.

    • cites [36] Anand V, et al. Closing the brief case: neonatal meningitis caused by listeria monocytogenes diagnosed by multiplex molecular panel. J Clin Microbiol. 2016;54(12):3075. source

      Not checked in the free run.

    • cites [37] Anand V, et al. The brief case: neonatal meningitis caused by listeria monocytogenes diagnosed by multiplex molecular panel. J Clin Microbiol. 2016;54(12):2846–9. source

      Not checked in the free run.

    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.
    • Rests on an assumption: The positivity rates and pathogen distributions in other published studies are comparable to the present setting.

  • May combine two claims.

    Premisecitation

    Radmard et al. reported a retrospective review of n=705 CSF specimens tested with an overall positivity rate of 6.5%; bacteria were detected in 15.21%, viruses in 80.43%, and yeast in 2.17% of positive samples.

    “d Radmard et al. reported a retrospective review of n = 705 CSF specimens tested with an overall positivity rate of 6.5%. In that study, bacteria were detected in 15.21%, viruses in 80.43% and yeast in 2.17% of positive samples, respectively.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Herpesviridae feature life-long latency after primary infection, and subclinical reactivation with replication can be seen in conjunction with different underlying clinical conditions.

    “As these viruses feature life-long latency after primary infection, subclinical reactivation with replication can be seen in conjunction with different underlying clinical conditions [43, 44].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [43] Ericsdotter AC, et al. Reactivation of herpes simplex type 1 in pneumococcal meningitis. J Clin Virol. 2015;66:100–2. source

      Not checked in the free run.

    • cites [44] Labska K, et al. Presence of herpesvirus DNA in cerebrospinal fluid of patients with tick-borne encephalitis and enteroviral meningoencephalitis. J Med Virol. 2015;87(7):1235–40. source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    Our restriction approach can be an easy and effective alternative.

    “Therefore we believe that our restriction approach can be an easy and effective alternative.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationown data

    Correlation of test results and underlying clinical symptoms requires experienced users and awareness of potentially false negative or false positive results.

    “However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    There is agreement that restriction of the assay might be helpful for enhancing its clinical utility.

    “Taken together, there is agreement that restriction of the assay might be helpful for enhancing its clinical utility.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning

    Our implementation approach is independent from approval by infectious disease specialists and it does not involve any ordering modifications.

    “Our implementation approach is independent from approval by infectious disease specialists and it does not involve any ordering modifications.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationcitation

    Overreliance on negative results might be crucial especially in geographical regions with unusual etiologic agents of meningitis, and this might yield ineffective testing.

    “Even though the FilmArray ME panel includes a broad range of pathogens, overreliance on negative results might be crucial especially in geographical regions with unusual etiologic agents of meningitis this might yield to ineffective testing [7].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [7] Tarai B, Das P. FilmArray(R) meningitis/encephalitis (ME) panel, a rapid molecular platform for diagnosis of CNS infections in a tertiary care hospital in North India: one-and-half-year review. Neurol Sci. 2019;40(1):81–8. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationown data

    The data gain new insights in how syndromic panel testing may be implemented into laboratory routine and therefore may help to identify the ideal approach to ensure its clinical utility.

    “Nevertheless we believe that our data gain new insights in how syndromic panel testing may be implemented into laboratory routine and therefore may help to identify the ideal approach to ensure its clinical utility.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.

  • May combine two claims.

    Study design and conductnone given

    The sample selection strategy was mainly based on gram-stain abnormalities, ensuring on-spot decision making, but not representing the ideal method for leucocyte detection.

    “Notably, sample selection strategy was mainly based on gram-stain abnormalities ensuring on-spot decision making, but not representing the ideal method for leucocyte detection.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.

  • May combine two claims.

    Study design and conductown data

    No clinical data was analyzed, hence effects on patient outcome or antibiotic utilization in this study remain unclear.

    “Moreover, no clinical data was analyzed, hence effects on patient outcome or antibiotic utilization in our study remain unclear.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductnone given

    Not all samples were assessed by all comparator assays; for samples not selected for FilmArray ME analysis, diagnostic was performed according to orders and no additional assays were performed.

    “Furthermore, we did not assess all samples by all comparator assays, in particular for samples that were not selected for FilmArray ME analysis, diagnostic was performed according to orders and no additional assays were performed.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    The authors of the latter study advise against potential overreliance on test results and suggest restriction strategies within the scope of diagnostic stewardship programs.

    “The authors advice against potential overreliance of test results and suggest restriction strategies within the scope of diagnostic stewardship programs [49].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [49] Patel R, Fang FC. Diagnostic stewardship: opportunity for a laboratory-infectious diseases partnership. Clin Infect Dis. 2018;67(5):799–801. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The relevance of HHV-6 detection in this study remains unclear in its consequences for patient management and outcome.

    “The relevance of HHV-6 detection in our study remains unclear in its consequences for patient management and outcome.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    No sample randomization was done.

    “no sample randomization was done.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Tan et al. describe a potential overutilization of the assay in children, but point out the benefits of early diagnosis of a viral etiology, especially in terms of antibiotic usage.

    “Corroborate findings were reported by Tan et al., who describe a potential overutilization of the assay in children, but yet point out the benefits of early diagnosis of a viral etiology, especially in terms of antibiotic usage [50].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [50] Tan NW, et al. Cerebrospinal fluid white cell count: discriminatory or otherwise for enteroviral meningitis in infants and young children? J Neuro-Oncol. 2016;22(2):213–7.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationcitation

    Molecular diagnostics are important for optimization of patient management.

    “underlining the importance of molecular diagnostic for optimization of patient management [40–42].”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [40] Negre VL, et al. Culture-negative neonatal meningitis and endocarditis caused by Streptococcus agalactiae. J Clin Microbiol. 2004;42(10):4889–90. source

      Not checked in the free run.

    • cites [41] Lu JJ, et al. Use of PCR with universal primers and restriction endonuclease digestions for detection and identification of common bacterial pathogens in cerebrospinal fluid. J Clin Microbiol. 2000;38(6):2076–80. source

      Not checked in the free run.

    • cites [42] Kristiansen BE, et al. Rapid diagnosis of meningococcal meningitis by polymerase chain reaction. Lancet. 1991;337(8757):1568–9. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Interpretationcitation

    Herpesviridae detection in CSF has questionable relevance in general.

    “one should also consider the questionable relevance of Herpesviridae detection in CSF in general.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [43] Ericsdotter AC, et al. Reactivation of herpes simplex type 1 in pneumococcal meningitis. J Clin Virol. 2015;66:100–2. source

      Not checked in the free run.

    • cites [44] Labska K, et al. Presence of herpesvirus DNA in cerebrospinal fluid of patients with tick-borne encephalitis and enteroviral meningoencephalitis. J Med Virol. 2015;87(7):1235–40. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Despite contradictory positions, the authors agree that the FilmArray ME panel ensures reduced turn-around time of molecular results and therefore might be beneficial for patient outcome.

    “Despite their contradictory positions on the use of the FilmArray ME panel in diagnostic laboratory routine, the authors agree on the fact that it ensures reduced turn-around time of molecular results and therefore might be beneficial for patient outcome.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] Dien Bard J, Alby K. Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory. J Clin Microbiol. 2018;56(4):e00018. source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationown data

    It cannot be excluded that in this sample, FilmArray ME detection of S. agalactiae was indeed false positive and the communication of the test result might have led to a dispensable antibiotic administration.

    “Otherwise, it cannot be excluded that in our sample, FilmArray ME detection of S.agalactiae was indeed false positive and the communication of the test result might have led to a dispensable antibiotic administration.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • May combine two claims.

    Interpretationown data

    The FilmArray ME is a useful tool for fast and reliable diagnostic of infectious meningitis in a real-life diagnostic setting and can be easily implemented in routine diagnostic workflows.

    “The FilmArray ME is a useful tool for fast and reliable diagnostic of infectious meningitis in a real life diagnostic setting and can be easily implemented in routine diagnostic workflows.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.
    • Rests on an assumption: The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

  • May combine two claims.

    Interpretationown data

    Detection of S. aureus, K. pneumoniae, and BK virus may account for serious infections.

    “detection of S. aureus, K. pneumoniae and BK-Virus may account for serious infections.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    This study focused on the implementation of the assay into the laboratory workflow, and no clinical data was analyzed.

    “As this study focused on the implementation of the assay into the laboratory workflow, no clinical data was analyzed.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    Implementation of criteria such as approval by infectious disease specialists might slow-down the whole workflow.

    “however, implementation of such criteria might slow-down the whole workflow.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Eichinger et al. reported that availability of rapid diagnostic tests enhances administration of specific treatment and reduces inadequate usage of antibiotics, but a structured approach in clinical implementation is needed.

    “Eichinger et al. reported their findings of implementation of the FilmArray ME panel as a POCT in children with suspected meningitis in a children hospital [51]. They highlight that though the availability of rapid diagnostic tests enhances administration of specific treatment and thus reduces inadequate usage of antibiotics, a structured approach in clinical implementation of the assay is needed.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [51] Eichinger A, et al. Clinical benefits of introducing real-time multiplex PCR for cerebrospinal fluid as routine diagnostic at a tertiary care pediatric center. Infection. 2019;47(1):51–8. source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductreasoning

    Clinical specimens were tested prospectively, but the selection strategy might exhibit a selection bias.

    “Clinical specimens were tested prospectively, yet our selection strategy might exhibit a selection bias.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.
59 of 59

  • The paper relies on this without support.

    A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy.

    “A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy.”

  • The paper relies on this without support.

    Direct identification of viral, bacterial and fungal pathogens in cerebrospinal fluid by molecular testing methods may substantially decrease the time to pathogen specific therapy.

    “Direct identification of viral, bacterial and fungal pathogens in cerebrospinal fluid (CSF) by molecular testing methods may substantially decrease the time to pathogen specific therapy.”

  • The paper relies on this without support.

    There is agreement that substantially decreased time-to-result has a potential benefit for patient outcome whenever involving an adaptation of antibiotic treatment.

    “Nevertheless, there is agreement regarding the substantially decreased time-to-result exhibiting a potential benefit for patient outcome whenever involving an adaptation of antibiotic treatment.”

  • The paper relies on this without support.

    Antimicrobial susceptibility testing is needed for management of infectious meningitis.

    “Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.”

  • The paper relies on this without support.

    The selection of CSF samples based on gram stain and/or urgent clinical suspicion identifies samples with a high pretest probability of infectious bacterial meningitis.

    “FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious (bacterial) meningitis. Decision was made in our laboratory based on gram stain and/or urgent suspicion of infectious meningitis communicated by clinicians”

  • The paper relies on this without support.

    The local comparator assays (culture and specific in-house PCRs) are valid reference methods for pathogen detection in CSF.

    “between the FilmArray ME panel results and our comparator assays”
    “compared to the local reference methods”

  • The paper relies on this without support.

    The positivity rates and pathogen distributions in other published studies are comparable to the present setting.

    “higher than in other published studies”
    “more than in other published studies”
7 of 7

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Previous studies have suggested that precautions should be taken when diagnosing a patient solely on FA/ME results and that additional confirmatory testing is still needed.

    “Previous studies have suggested that precautions should be taken when diagnosing a patient based solely on FA/ME results and that additional confirmatory testing is still needed (17, 23, 24).”

    From Evaluation of the Novel CE-IVD-Marked Multiplex PCR QIAstat-Dx Meningitis/Encephalitis Panel (2023) · cites this paper as [24]

  • In this study, with a relatively small sample size, the positive and negative percent agreements of QIA/ME and FA/ME were slightly better than the specificity and sensitivity values seen in previous studies evaluating FA/ME.

    “In this study, with a relatively small sample size, the positive and negative percent agreements of QIA/ME and FA/ME (Tables 3 to 5) were slightly better than the specificity and sensitivity values seen in previous studies evaluating FA/ME (17–24).”

    From Evaluation of the Novel CE-IVD-Marked Multiplex PCR QIAstat-Dx Meningitis/Encephalitis Panel (2023) · cites this paper as [24]

  • A multicenter evaluation of the FilmArray ME panel reported 100% sensitivity for most bacterial pathogens and over 99% specificity.

    “a multicenter evaluation of the FilmArray ME panel reported 100% sensitivity for most bacterial pathogens and over 99% specificity9.”

    From Clinical Impact of Cerebrospinal Fluid Multiplex Polymerase Chain Reaction (PCR) Testing in Children with Suspected Central Nervous System Infection (2025) · cites this paper as [9]

    The Background and the Results comparison discuss a separate multicenter evaluation, but do not give its sensitivity or specificity. The 96.30% sensitivity and 96.58% specificity in Clinical performance are from this paper's own laboratory study; they cannot verify the claimed figures for the multicenter evaluation (searched: 100% sensitivity, over 99% specificity, multicenter evaluation). (LLM, conf=0.76)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

  • Clinician-requested positivity rate does not match its count

    Major

    The reported 44 positive samples out of 54 would give 81.48%, not 22.22%. The reported percentage would correspond to 12 out of 54.

    Reported 22.22 · recomputed 81.481481

  • Gram-stain counts exceed the stated subset

    Minor

    The stated positive- and negative-Gram-stain counts add to 31, but the subset contains only 30 samples.

    Reported 30 · recomputed 31

2 of 2

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Kniehl E, Dörries H, Geiss RK, Matz B, Neumann-Häfelin D, Pfister HW, Prange H, Schlüter B, Spellerberg FB. Spencker MIQ 17: Qualitätsstandards in der mikrobiologisch-infektiologischen Diagnostik: Infektionen des Zentralnervensystems; 2001.

Cited by

Sorted by citations

Related

Authors
Pfefferle, S., Christner, M., Aepfelbacher, M., Lütgehetmann, M., & Rohde, H.
Affiliations
University Medical Center Hamburg-Eppendorf (DE)
Corresponding author
Pfefferle, Susanne
ORCID
Venue
BMC Infectious Diseases
Publisher
Springer Science and Business Media LLC
Published
2020-02-22
Volume
20
Issue
1
Pages
170-170
ISSN
1471-2334 (ISSN-L)
DOI
10.1186/s12879-020-4904-4
PMC
PMC7036261
OpenAlex
W3012853201
Semantic Scholar
1384c024fbf1144cd6e8eef44f3277e4835063d0
Cited by
36
References
50
Citations by year
2026: 4 · 2025: 4 · 2024: 2 · 2023: 5 · 2022: 10 · 2021: 7 · 2020: 2 · 2019: 1 · 2018: 1
FWCI
3.98
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Infectious Diseases (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
  • Health Sciences › Medicine › Infectious Diseases › Infectious Encephalopathies and Encephalitis
Keywords
infectious meningitis, encephalitis, cerebrospinal fluid, molecular diagnosis, sample selection strategy, diagnostic accuracy, pathogenic bacteria, viral pathogens, false positives, antimicrobial susceptibility testing, clinical implementation
MeSH terms
Diagnostic Tests, Routine, Encephalitis, Gentian Violet, Germany, Hospitals, University, Humans, Laboratories, Meningitis, Phenazines, Prospective Studies, Sensitivity and Specificity, Staining and Labeling, Reproducibility of Results, Molecular Diagnostic Techniques, Multiplex Polymerase Chain Reaction, Tertiary Care Centers

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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