National mycology laboratory diagnostic capacity for invasive fungal diseases in 2017: Evidence of sub-optimal practice PubMed 2019
This report (PMID: 31233810) showed that fungal diagnostics were not available in most laboratories. β-D-Glucan was only available in 5% of responding laboratories, similarly Aspergillus serum galactomannan was only available in 21% and 16% for BAL galactomannan. Aspergillus antibody testing was also mainly referred – as was Cryptococcal antigen testing – both 63%. 14% of laboratories performing Cryptococcus antigen test used lateral flow tests whilst 24% used an agglutination technique.
This report (PMID: 31233810) showed that fungal diagnostics were not available in most laboratories. β-D-Glucan was only available in 5% of responding laboratories, similarly Aspergillus serum galactomannan was only available in 21% and 16% for BAL galactomannan. Aspergillus antibody testing was also mainly referred – as was Cryptococcal antigen testing – both 63%. 14% of laboratories performing Cryptococcus antigen test used lateral flow tests whilst 24% used an agglutination technique.
COMBINATIONS LATERAL FLOW ASSAYS - QUALITATIVE TO QUANTITATIVE MOLECULAR AUTOMATION
COMBINATIONS
Recent Advances and Novel Approaches in Laboratory-Based Diagnostic Mycology Medical Mycology 2020
'The application of digital readers-which provide a quantitative output are a major improvement when using LFD, removing subjectivity and providing a value for clinical interpretation and have been identified as critical to clinical use, can be applied to both serum and BAL fluid'
'Lateral flow assays simplify testing and turn-around time, with potential for point of care testing,'
'Commercial molecular assays increase the applicability of PCR testing and may identify markers of antifungal resistance, which are of great clinical concern.'
'The application of digital readers-which provide a quantitative output are a major improvement when using LFD, removing subjectivity and providing a value for clinical interpretation and have been identified as critical to clinical use, can be applied to both serum and BAL fluid'
'Lateral flow assays simplify testing and turn-around time, with potential for point of care testing,'
'Commercial molecular assays increase the applicability of PCR testing and may identify markers of antifungal resistance, which are of great clinical concern.'
The significance of combination detection of Aspergillus antigen and antibody lateral flow assay for invasive pulmonary aspergillosis diagnosis ECCMID 2021
'the Aspergillus antibody detection test can effectively avoid the shortcomings of the GM test, and the combined detection can highly improve the detection accuracy. The combination detection of FungiXpert® Aspergillus IgG, IgM and galactomannan lateral flow assay exhibits excellent sensitivity, specificity and accuracy for serological diagnosis of IPA.'
'the Aspergillus antibody detection test can effectively avoid the shortcomings of the GM test, and the combined detection can highly improve the detection accuracy. The combination detection of FungiXpert® Aspergillus IgG, IgM and galactomannan lateral flow assay exhibits excellent sensitivity, specificity and accuracy for serological diagnosis of IPA.'
Diagnostic value of serum galactomannan, (1,3)-β-d-glucan, and Aspergillus fumigatus-specific IgA and IgG assays for invasive pulmonary aspergillosis in non-neutropenic patients Mycoses 2018
The involvement of the IgAG assay could improve IPA diagnosis in non-neutropenic patients by increasing the sensitivity and NPV when combined with the GM or BG assays. Furthermore, improvement was achieved by combining the GM, BG and IgAG assays using the “at least one positive test” strategy, especially if doubt exists.
The involvement of the IgAG assay could improve IPA diagnosis in non-neutropenic patients by increasing the sensitivity and NPV when combined with the GM or BG assays. Furthermore, improvement was achieved by combining the GM, BG and IgAG assays using the “at least one positive test” strategy, especially if doubt exists.
Rapid diagnosis and treatment of fungal infections Policy@Manchester 2022
'Rapid diagnostics are required for the timely diagnosis of fungal disease in patients with advanced HIV and AIDS.'
'chronic pulmonary aspergillosis is often mistaken for tuberculosis due to the similar symptoms these diseases share. They can be distinguished with appropriate diagnostics,'
'recent research from India, Vietnam and Ghana show that 54-57% of patients who had completed their 6-month treatment course for TB – but then had new symptoms and a suspected relapse of TB – actually had CPA.'
'Another area where diagnosis of fungal infections has an enormous impact on patient health is during HIV infection and AIDS. HIV and AIDS patients have compromised immune systems and are at greater risk of serious fungal infections.'
'Rapid diagnostics are required for the timely diagnosis of fungal disease in patients with advanced HIV and AIDS.'
'chronic pulmonary aspergillosis is often mistaken for tuberculosis due to the similar symptoms these diseases share. They can be distinguished with appropriate diagnostics,'
'recent research from India, Vietnam and Ghana show that 54-57% of patients who had completed their 6-month treatment course for TB – but then had new symptoms and a suspected relapse of TB – actually had CPA.'
'Another area where diagnosis of fungal infections has an enormous impact on patient health is during HIV infection and AIDS. HIV and AIDS patients have compromised immune systems and are at greater risk of serious fungal infections.'
LATERAL FLOW ASSAYS - QUALITATIVE TO QUANTITATIVE
Evaluation of a Novel Semiquantitative Cryptococcal Antigen Lateral Flow Assay in Patients with Advanced HIV Disease JCM 2020
Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification.
Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification.
Evaluation of the Diagnostic Performance of a Semiquantitative Cryptococcal Antigen Point-of-Care Assay among HIV-Infected Persons with Cryptococcal Meningitis JCM 2020
Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification. CrAg semi-quantitative scores were strongly associated with 10-week mortality.
Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification. CrAg semi-quantitative scores were strongly associated with 10-week mortality.
Neglecting Genetic Diversity Hinders Timely Diagnosis of Cryptococcus Infections JCM 2021
Four CE-IVD marked LFAs were tested: cryptococcal antigen LFA (IMMY ), CryptoPS (Biosynex,), cryptococcal antigen LFA (Dynamiker), and cryptococcal capsular polysaccharide detection K-set (FungiXpert, Genobio Pharmaceutical,). Forty cryptococcal strains comprising all seven recognized species and their interspecies hybrids were tested.
All seven pathogenic Cryptococcus species were detected by the IMMY Diagnostics and FungiXpert LFAs. Two LFAs had a blind spot with C. tetragattii, a worrisome false-negative result because C. tetragattii infections are common in sub-Saharan Africa and the Indian subcontinent,
Four CE-IVD marked LFAs were tested: cryptococcal antigen LFA (IMMY ), CryptoPS (Biosynex,), cryptococcal antigen LFA (Dynamiker), and cryptococcal capsular polysaccharide detection K-set (FungiXpert, Genobio Pharmaceutical,). Forty cryptococcal strains comprising all seven recognized species and their interspecies hybrids were tested.
All seven pathogenic Cryptococcus species were detected by the IMMY Diagnostics and FungiXpert LFAs. Two LFAs had a blind spot with C. tetragattii, a worrisome false-negative result because C. tetragattii infections are common in sub-Saharan Africa and the Indian subcontinent,
Evaluation of a Cryptococcus capsular polysaccharide detection FungiXpert LFA (lateral flow assay) for the rapid diagnosis of Cryptococcosis Med Mycol 2022 Compared to IMMY CrAg LFA, the FungiXpert LFA demonstrated 99.1% sensitivity and 98.9% specificity in the qualitative test. Compared with the IMMY CrAg LFA, the FungiXpert LFA showed an equal, yet, excellent performance.
FungiXpert Quantitative Lateral Flow Assays
Cryptococcal Capsular Polysaccharide
Aspergillus Galactomannan
Aspergillus lgG Antibody
Aspergillus lgM Antibody
Candida Mannan
Candida Mannan lgG Antibody
Candida Mannan lgM Antibody
Cryptococcal Capsular Polysaccharide
Aspergillus Galactomannan
Aspergillus lgG Antibody
Aspergillus lgM Antibody
Candida Mannan
Candida Mannan lgG Antibody
Candida Mannan lgM Antibody
MOLECULAR
Molecular Diagnosis of Yeast Infections Clin Path 2021
'The use of molecular tests to aid the diagnosis of invasive yeast infection, in particular invasive candidosis, has been described for over two decades, yet widespread application is limited, and diagnosis remains heavily dependent on classical microbiology. This article will review developments from the past decade in attempt to build on existing knowledge.'
'The impact of molecular diagnostics for invasive yeast infections has been limited by a lack of standardization and commercial assays. With both being addressed, it is hoped that molecular testing will become routine practice, making the potential benefits widely available.'
'With an ever-increasing population at risk of yeast infections, the range of potential pathogens will undoubtedly evolve, and it is essential that technology be embraced to ensure an accurate and timely diagnosis.'
'The use of molecular tests to aid the diagnosis of invasive yeast infection, in particular invasive candidosis, has been described for over two decades, yet widespread application is limited, and diagnosis remains heavily dependent on classical microbiology. This article will review developments from the past decade in attempt to build on existing knowledge.'
'The impact of molecular diagnostics for invasive yeast infections has been limited by a lack of standardization and commercial assays. With both being addressed, it is hoped that molecular testing will become routine practice, making the potential benefits widely available.'
'With an ever-increasing population at risk of yeast infections, the range of potential pathogens will undoubtedly evolve, and it is essential that technology be embraced to ensure an accurate and timely diagnosis.'
Diagnosis of invasive fungal infections in haematological patients by combined use of galactomannan, 1,3-β-D-glucan, Aspergillus PCR, multifungal DNA-microarray, and Aspergillus azole resistance PCRs in blood and bronchoalveolar lavage samples: results of a prospective multicentre study Clin Microbiol Infection 2016
Combining GM (BAL) with PCR (BAL) showed convincing diagnostic potential for diagnosing IA with sensitivity, specificity, PPV, NPV, and DOR of 85% (17/20), 97% (28/29), 94%, 90%, and 158.7. Combination of biomarkers is superior to their sole use in diagnosing IFD, particularly IA. Integrating blood and BAL samples into a diagnostic algorithm is an advantageous approach.
Combining GM (BAL) with PCR (BAL) showed convincing diagnostic potential for diagnosing IA with sensitivity, specificity, PPV, NPV, and DOR of 85% (17/20), 97% (28/29), 94%, 90%, and 158.7. Combination of biomarkers is superior to their sole use in diagnosing IFD, particularly IA. Integrating blood and BAL samples into a diagnostic algorithm is an advantageous approach.
Comparison of different microbiological procedures for the diagnosis of Pneumocystis jirovecii pneumonia on bronchoalveolar-lavage fluid BMC Microbiology 2022
'Our work highlights the need of reshaping and redefining the role of molecular diagnostics in a peculiar clinical setting, like P. jirovecii infection, which is a rare but also severe and rapidly progressive clinical condition affecting immunocompromised hosts that would largely benefit from a faster diagnosis. Strictly selected patients, according to the inclusion criteria, resulting negative by molecular methods could be ruled out for P. jirovecii pneumonia.'
'Our work highlights the need of reshaping and redefining the role of molecular diagnostics in a peculiar clinical setting, like P. jirovecii infection, which is a rare but also severe and rapidly progressive clinical condition affecting immunocompromised hosts that would largely benefit from a faster diagnosis. Strictly selected patients, according to the inclusion criteria, resulting negative by molecular methods could be ruled out for P. jirovecii pneumonia.'
A New Age in Molecular Diagnostics for Invasive Fungal Disease: Are We Ready? Front. Microbiol., 2020
'Early diagnosis encompassing accurate detection and identification of the causative agent and of antifungal resistance is critical for optimum patient outcomes. Many molecular-based diagnostic approaches have good clinical utility although interpretation of results should be according to clinical context.'
'Aspergillus PCR assays has now enabled direct comparison of results between laboratories with commercial assays also offering the simultaneous detection of common azole resistance mutations. Candida PCR assays are not as well standardized with the only FDA-approved commercial system (T2Candida) detecting only the five most common species;'
'Early diagnosis encompassing accurate detection and identification of the causative agent and of antifungal resistance is critical for optimum patient outcomes. Many molecular-based diagnostic approaches have good clinical utility although interpretation of results should be according to clinical context.'
'Aspergillus PCR assays has now enabled direct comparison of results between laboratories with commercial assays also offering the simultaneous detection of common azole resistance mutations. Candida PCR assays are not as well standardized with the only FDA-approved commercial system (T2Candida) detecting only the five most common species;'
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The ERA Biology Real-time PCR range.
Aspergillus, Candida Albicans Molecular Detection Kit (Real-time PCR) Cryptococcus Molecular Detection Kit (Real-time PCR) Convenient- Sample pretreatment simplifies nucleic acid extraction Accurate - the reagent is stored, freeze dried, in PCR tube to reduce the possibility of contamination. |
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AUTOMATION
Fungitell for antifungal treatment stratification August 2017
'One specialist commentator considered that the greatest benefit from the Fungitell test would be if it were available on demand, with samples processed individually or in small batches.'
'The cost of Fungitell is £737.05 per test kit (excluding VAT), which can run up to 42 patient samples in duplicate, plus the cost of additional lab-based consumables and equipment. The cost per patient therefore depends on the number of samples in each run.'
'One specialist commentator considered that the greatest benefit from the Fungitell test would be if it were available on demand, with samples processed individually or in small batches.'
'The cost of Fungitell is £737.05 per test kit (excluding VAT), which can run up to 42 patient samples in duplicate, plus the cost of additional lab-based consumables and equipment. The cost per patient therefore depends on the number of samples in each run.'
Performance characteristics of Fungitell STAT™ Med Mycol2021'Assay workflow duration - Once trained in the execution of the Fungitell STAT™ assay, the average hands-on time required for the preparation and pre-incubation of a standard and one or two samples through insertion into the instrument to start the kinetic assay was 30 minutes. The maximum time observed was 58 minutes and minimum time observed was 19 minutes.'
Novel Diagnostic Method for Fungal Infection — (1,3)-β-D-Glucan Chemiluminescence Immunoassay ECCMID 2021
'the application of FACIS-I makes the (1,3)-β-D-Glucan detection experiment full-automatic, rapid and intelligent.'
'The FACIS exhibits excellent coincident rate results for serological diagnosis compared with routinely-used chromogenic methods, which indicated that a new (1,3)-β-D-Glucan detection method was emerged.'
'the application of FACIS-I makes the (1,3)-β-D-Glucan detection experiment full-automatic, rapid and intelligent.'
'The FACIS exhibits excellent coincident rate results for serological diagnosis compared with routinely-used chromogenic methods, which indicated that a new (1,3)-β-D-Glucan detection method was emerged.'
FACIS -Full-Automatic Chemiluminescence Immunoassay System for Fungal Diagnostics.
FACIS is an open system to detect the content of endotoxin, (1-3)-β-D-glucan and galactomannan in human BAL fluid or serum samples. With both photometry system and chemiluminescence system built in, FACIS provides rapid and reliable results for over 10 tests that use CLIA or chromogenic method, including but not limited to fungus (1-3)-β-D-glucan test, bacterial endotoxin test, aspergillus galactomannan test, procalcitonin, C-Reactive protein and candida mannan tests. The FACIS process is suitable for single or multiple sample and fast and simple enough to offer a 24/7 service.
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T: 01782 516 010
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