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The article 'fatal nosocomial hemorrhagic enterocolitis probably caused by adenovirus.Report of one case' by fica et al1 describes a patient death case involving a potential false negative adv result on the filmarray gi panel.The patient was a (b)(6) year old female who was initially admitted to the hospital with influenza a (h1n1) pneumonia.Mechanical ventilation was required and the patient received empirical therapy including ceftriaxone, levofloxacin, and oseltamivir.On day 9 of hospitalization, hemodialysis was initiated as the patient presented with acute renal failure, and methylprednisolone was given for 3 days for suspected alveolar hemorrhage.On day 14, the patient developed profuse watery diarrhea (2.5 l/day), and a patient sample was tested on the filmarray gi panel.The filmarray gi panel result was negative for all analytes.It is unknown if one or more filmarray gi panel tests were performed and if there was more than one negative result.The stool sample used was watery diarrhea, and was not transferred to cary-blair media before being tested on the filmarray gi panel (therefore was an off-label sample type).No other testing was reported on the stool sample.On day 17, a colonoscopy showed that the patient had ulcerative pancolitis.Gancyclovir was prescribed for 7 days on the suspicion of cytomegalovirus (cmv), but testing of a blood sample and a immunohistochemical was negative for cmv, hsv-1, and hsv-2.The etiology investigation of the patient's protracted diarrhea was expanded, and adv was confirmed on a colonic biopsy sample using biomerieux's adenovirus r-gene® kit.In response to the adv enterocolitis diagnosis, cidofovir with probenecid was initiated on day 30.The response to the treatment was uncertain as the patient continued to have a cyclic course of diarrhea.New complications presented, including septic shock, bacteremia, and bacterial pneumoniae secondary to pseudomonas aeruginosa.On day 49, an endoscopy and colonoscopy indicated persistence of ulcers with bleeding.Biopsies of the upper gastrointestinal tract were then tested on pcr and were negative for adv.The article reported that corticosteroids in high doses, acute renal failure, and persistent lymphopenia led to a hospital-acquired adv infection that was unresponsive to antiviral therapy and eventually led to patient death.The article stated that "the filmarray gi panel did not detect adv on stool samples in our patient but this fact was not surprising due to the restricted adv repertoire of this technique able only to detect serotypes 40 and 41 of the adv species f." the article also claimed that the negative filmarray gi panel result delayed appropriate treatment and allowed clinical deterioration.Notably, the biopsy sample that was positive on adenovirus r-gene® was not tested on the filmarray gi panel, and the stool sample that was negative on the filmarray gi panel was not tested for adv with any other method.The adv was not sequenced to identify the species/subtype.The customer did not have sample remaining for further testing, and biofire has been unable to receive the filmarray gi panel run file(s).Conclusion: because no other comparator methods were performed on the raw stool sample, and because the positive adenovirus r-gene® result was from a different sample tested several days after the filmarray gi panel, internal investigation concluded that insufficient information was available to determine if an error occurred.The filmarray gi panel contains a single multiplexed assay (adenof) for the specific detection of both adv f40 and f41 (i.E.Will not cross-react with non-40/41 adv species/subtypes when shed in the stool; e.G.From a respiratory adv).The reported results do not indicate which serotype (40 or 41) has been detected.The assay will not detect other adv species, such as species b, c, and e, which are associated with respiratory infections.The authors understood the adv inclusivity limitation of the filmarray gi panel and this was addressed in the article.Adv was confirmed using adenovirus r-gene® on a colonic biopsy sample, but this positive result was not sequenced and the colonic biopsy sample was not tested on a filmarray gi panel, so it is unclear if the adv strain had reduced sensitivity on the filmarray gi panel or was a non-targeted species/subtype.Note: filmarray gi panel results may be affected by concurrent antibacterial therapy or levels of organism in the sample that are below the limit of detection (lod) of the test.The performance of this test has not been evaluated for immunocompromised individuals, and has only been validated with human stool collected in cary blair transport medium according to the media manufacturers' instructions.The filmarray gi panel has not been validated for use with raw stool.A negative filmarray gi panel result does not exclude the possibility of gastrointestinal infection.Negative test results may occur from sequence variants in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up, or an infection caused by an organism not detected by the panel.Negative results should not be used as the sole basis for diagnosis, treatment, or other management decisions.The detection of organism nucleic acid is dependent upon proper sample collection, handling, transportation, storage, and preparation.Failure to observe proper procedures in any one of these steps can lead to false positive and false negative results.According to the filmarray gi panel instruction booklet, the adv f 40/41 assay was determined to have an lod of 1-100 tcid50/ml (table 18).Clinical performance of the adv f 40/41 assay, as compared to pcr with bi-directional sequencing, showed a ppa of 95.5% (95% ci 84.5-99.4) and an npa of 99.1% (95% ci 98.5-99.5) (table 11, https://www.Online-ifu.Com/iti0030).References: fica a, cataldo p, aceituno d, villarroel mi, escalona a.Fatal nosocomial hemorrhagic enterocolitis probably caused by adenovirus.Report of one case.Revista médica de chile.2019;147(2):256-260.Doi:10.4067/s0034-98872019000200256.
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An article by fica et al1 describes a patient death case involving a potentially discrepant adenovirus (adv) result (potentially more than one result) on the filmarray gastrointestinal (gi) panel.The patient died due to renal failure, and the article claims that the filmarray gi panel result(s) delayed appropriate treatment and allowed clinical deterioration of the patient.No other comparator methods were performed on the sample, and the filmarray gi panel test run file(s) was not provided.Testing of a colonic biopsy specimen with another molecular method detected an adenovirus (unknown species/subtype; the filmarray gi panel only detects adv f40 and f41).Based on the information provided, internal investigation concluded that insufficient information was available to determine if an error occurred.It is possible that the adv detected was not adv f40 or f41 (a species/subtype not targeted by the filmarray gi panel); it is also possible that the level of adv was below the limit of detection for the filmarray gi panel.Additionally, the specimen used (raw stool) is an off-label sample type.References: fica a, cataldo p, aceituno d, villarroel mi, escalona a.Fatal nosocomial hemorrhagic enterocolitis probably caused by adenovirus.Report of one case.Revista médica de chile.2019;147(2):256-260.Doi:10.4067/s0034-98872019000200256.
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