Evaluation of Analytical and Preliminary Clinical Performance of Myconostica MycAssay Aspergillus When Testing Serum Specimens for Diagnosis of Invasive Aspergillosis

White, P. Lewis; Perry, M. D.; Moody, Adrian; Follett, Sarah A.; Morgan, Gillian M.; Barnes, Rosemary Ann

doi:10.1128/jcm.00101-11

Cited by 79 publications

(42 citation statements)

References 23 publications

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“…The negative predictive value was 99.3%, with corresponding sensitivity of 94.1% and specificity of 98.5%. The performance of this PCR assay compared favorably with that in other studies using the MycAssay Aspergillus PCR to test serum (44) or respiratory tract (9) specimens, yielding high likelihood ratios of probable or proven IA for a positive test result. It was also superior to that shown by an in-house PCR assay (40), but not at a statistically significant level (Table 2), or to that reported in a systematic review of PCR assays (42).…”

Section: Discussionmentioning

confidence: 55%

Diagnosis of Invasive Aspergillosis by a Commercial Real-Time PCR Assay for Aspergillus DNA in Bronchoalveolar Lavage Fluid Samples from High-Risk Patients Compared to a Galactomannan Enzyme Immunoassay

Torelli¹,

Sanguinetti²,

Moody

et al. 2011

J Clin Microbiol

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120

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Culture-independent molecular techniques such as real-time PCRs offer the potential for early diagnosis of invasive aspergillosis (IA), thereby reducing the disease-associated mortality rate. PCR-based testing is presently excluded from disease-defining consensus criteria due to lack of standardization and clinical validation. A single-center prospective study was conducted to investigate the performance of the commercially available MycAssay Aspergillus test for detecting Aspergillus DNA in patients with suspicion of IA. To this end, a total of 158 bronchoalveolar lavage (BAL) fluid specimens that were consecutively collected from hematology (n ‫؍‬ 68) and intensive care unit (n ‫؍‬ 90) patients were examined. Sixteen of 17 (94.1%) specimens from patients with proven/probable IA were MycAssay positive, and 15 of these 16 patients were also positive by an "in-house" PCR assay. A total of 139 of 141 (98.6%) specimens from patients without proven/probable IA were MycAssay negative. Fifteen of 16 (94.1%) MycAssay-positive patients were also positive for BAL fluid galactomannan (GM) at an index cutoff of >1.0 (index range, 1.1 to 8.3), as were 3 patients without IA but with pulmonary fusariosis. Interestingly, in seven of the PCR-positive BAL specimens that tested culture positive for Aspergillus species, cycle threshold values were earlier than those of specimens with a culture-negative result. In conclusion, the MycAssay Aspergillus PCR appears to be a sensitive and specific molecular test for the diagnosis of IA, and its performance is comparable to that of the GM assay. However, more large studies are necessary to firmly establish its clinical utility in high-risk settings.

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Section: Discussionmentioning

confidence: 55%

Diagnosis of Invasive Aspergillosis by a Commercial Real-Time PCR Assay for Aspergillus DNA in Bronchoalveolar Lavage Fluid Samples from High-Risk Patients Compared to a Galactomannan Enzyme Immunoassay

Torelli¹,

Sanguinetti²,

Moody

et al. 2011

J Clin Microbiol

Self Cite

120

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“…1). Twentythree studies provided data for PCR based on the 2002 EORTC/ MSG criteria , and 14 did so by using the revised (2008) criteria (47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59)(60) (Table 1).…”

Section: Resultsmentioning

confidence: 99%

PCR in Diagnosis of Invasive Aspergillosis: a Meta-Analysis of Diagnostic Performance

et al. 2014

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Invasive aspergillosis is a difficult-to-diagnose infection with a high mortality rate that affects high-risk groups such as patients with neutropenia and hematologic malignancies. We performed a bivariate meta-analysis of diagnostic data for an Aspergillus sp. PCR assay with blood specimens from high-risk hematology patients. We included all studies involving human subjects that assessed the performance of any PCR assay for invasive aspergillosis in whole blood or serum and that used the European Organization for the treatment of Cancer/Mycoses Study Group criteria as a reference standard. Three investigators independently searched the literature for eligible studies and extracted the data. Out of a total of 37 studies, 25 met strict quality criteria and were included in our evidence synthesis. Twenty-five studies with 2,595 patients were analyzed. The pooled diagnostic performance of whole-blood and serum PCR assays was moderate, with a sensitivity and specificity of 84% (95% confidence interval [CI], 75 to 91%) and 76% (95% CI, 65 to 84%), respectively, suggesting that a positive or negative result is unable, on its own, to confirm or exclude a suspected infection. The performance of a PCR assay of serum was not significantly different from that of whole blood. Notably, at least two positive PCR test results were found to have a specificity of 95% and a sensitivity of 64% for invasive infection, achieving a high positive likelihood ratio of 12.8. Importantly, the European Aspergillus PCR Initiative (EAP-CRI) recommendations improved the performance of the PCR even further when at least two positive specimens were used to define PCR positivity. In conclusion, two positive PCR results should be considered highly indicative of an active Aspergillus sp. infection. Use of the EAPCRI recommendations by clinical laboratories can further enhance PCR performance. D espite advances in treatment and supportive care, invasive aspergillosis (IA) is associated with significant morbidity and mortality rates, especially among patients with hematologic malignancies and hematopoietic stem cell transplant (HSCT) recipients (1, 2). Systemic antifungal prophylaxis is widely used in this patient population (3, 4), and patients with recurrent or persistent fever and prolonged neutropenia frequently require empirical coverage with antifungal agents (5). Timely and accurate diagnosis of an active infection is needed in order to initiate targeted antifungal therapy and avoid unnecessary antifungal treatment, which is often accompanied by a multitude of side effects and the cumulative risk of resistance.There is a need for the development of newer diagnostic techniques that would ideally be able to identify IA rapidly, noninvasively, and at an early stage. To aid in this endeavor, the European Organization for the treatment of Cancer/Mycoses Study Group (EORTC/MSG) developed specific criteria for the diagnosis of IA in 2002 (6), which were later revised in 2008 (7), in an attempt to provide the elusive "gold standard" to which any newe...

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“…DNA was purified by using the High Pure PCR template preparation kit (Roche) (17). Briefly, 0.5 ml of serum was mixed with 0.4 ml of binding buffer and 80 l of recombinant proteinase K (Roche), and the mixture was incubated at 70°C for 10 min.…”

Section: Methodsmentioning

confidence: 99%

Multicenter Comparison of Serum and Whole-Blood Specimens for Detection of Aspergillus DNA in High-Risk Hematological Patients

et al. 2013

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. Forty-seven cases (proven and probable IA) and 31 controls (no evidence of IA) were selected retrospectively for this case-control study, comprising 803 samples, in order to determine the performance of whole-blood PCR, serum PCR, and serum galactomannan testing. Although no single assay was able to detect every case of IA, a combination of different assays provided the best performance. There was no significant difference between the use of whole-blood and serum specimens for PCR-based diagnosis of IA, but there was a trend for whole blood to be more sensitive (85% versus 79%) and to yield an earlier positive result (36 days versus 15 days) than for serum. However, DNA extraction from serum specimens is easier and faster than that from whole-blood specimens, and it allows the same specimen to be used for both galactomannan and PCR assays. In conclusion, the appropriate sample type for DNA extraction should be determined by the local requirements and the technical platforms available at each individual center. A combination of biomarker tests offered the best diagnostic utility for detecting IA.

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Evaluation of Analytical and Preliminary Clinical Performance of Myconostica MycAssay Aspergillus When Testing Serum Specimens for Diagnosis of Invasive Aspergillosis

Cited by 79 publications

References 23 publications

Diagnosis of Invasive Aspergillosis by a Commercial Real-Time PCR Assay for Aspergillus DNA in Bronchoalveolar Lavage Fluid Samples from High-Risk Patients Compared to a Galactomannan Enzyme Immunoassay

Diagnosis of Invasive Aspergillosis by a Commercial Real-Time PCR Assay for Aspergillus DNA in Bronchoalveolar Lavage Fluid Samples from High-Risk Patients Compared to a Galactomannan Enzyme Immunoassay

PCR in Diagnosis of Invasive Aspergillosis: a Meta-Analysis of Diagnostic Performance

Multicenter Comparison of Serum and Whole-Blood Specimens for Detection of Aspergillus DNA in High-Risk Hematological Patients

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