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Comparison of a Lateral Flow Assay and a Latex Agglutination Test for the Diagnosis of Cryptococcus Neoformans Infection.

ABSTRACT: Infections by the basidiomycete yeast Cryptococcus neoformans are life-threatening diseases claiming more than 600,000 lives every year. The most common manifestation is cryptococcal meningitis in AIDS patients. Diagnosis primarily relies on antigen testing from serum and cerebrospinal fluid (CSF). Current guidelines recommend rapid antigen testing with a focus on point-of-care assays. Over the recent years, a range of new lateral flow assays (LFAs) was launched. There is still a lack of data evaluating the CE-certified Biosynex RDT CryptoPS LFA. We compared the performance of this LFA with a latex agglutination assay (LAA; Latex-Cryptococcus Antigen Detection System, IMMY) from blood and CSF samples. Blood and/or CSF samples of 27 patients with proven cryptococcal infections caused by different species and blood-CSF pairs of 20 controls were tested applying LFA and LAA. Upon combined analysis of blood and CSF, both assays were able to identify all C. neoformans infections. Based on CSF analysis only, the LFA and the LAA had sensitivities of 100% and 93%. Neither test gave false-positive results nor was reactive in two cases of C. non-neoformans/non-gattii species infections. Both assays have high sensitivities and specificities for the diagnosis of C. neoformans infection. Contrarily to the IMMY LAA, the RDT CryptoPS LFA is suitable as a point-of-care test but is limited in the quantification of antigen reactivity.

SUBMITTER: Schub T

PROVIDER: S-EPMC8486725 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLeptospirosis is diagnosed on clinical grounds, and confirmed by microscopic agglutination test (MAT). IgM-ELISA (Serion-Virion) and immunochromatography test (Leptocheck-WB) are two immunodiagnostic assays for leptospirosis. Their sensitivity, specificity and applicability in Sri Lanka have not been systematically evaluated.MethodsClinically diagnosed leptospirosis patients (n = 919) were recruited from three hospitals in the Western Province of Sri Lanka, during June 2012 to December 2013. MAT, IgM-ELISA and Leptocheck-WB were performed on all patient sera. MAT titer of ? 400 in single sample, four-fold rise or seroconversion ? 100 in paired samples were considered as positive for MAT. For diagnostic confirmation, MAT was performed during both acute and convalescent phases. Anti-leptospiral IgM ? 20 IU/ml and appearance of a band in the test window were considered as positive for IgM-ELISA and Leptocheck-WB test respectively. Patients with an alternative diagnosis (n = 31) were excluded. Data analysis was performed using two methods, i) considering MAT as reference standard and ii) using Bayesian latent class model analysis (BLCM) which considers each test as imperfect.ResultsMAT, IgM-ELISA and Leptocheck-WB positivity were 39.8%, 45.8% and 38.7% respectively during the acute phase. Acute-phase MAT had specificity and sensitivity of 95.7% and 55.3% respectively, when compared to overall MAT positivity. IgM-ELISA and Leptocheck-WB had similar diagnostic sensitivity when compared with acute-phase MAT as the gold standard, although IgM-ELISA showed higher specificity (84.5%) than Leptocheck-WB (73.3%). BLCM analysis showed that IgM-ELISA and Leptocheck-WB had similar sensitivities (86.0% and 87.4%), while acute-phase MAT had the lowest sensitivity (77.4%). However, acute-phase MAT had high specificity (97.6%), while IgM-ELISA and Leptocheck-WB showed similar but lower specificity (84.5% and 82.9%).ConclusionsBoth IgM-ELISA and Leptocheck-WB shows similar sensitivities and specificities. IgM-ELISA may be superior to MAT during the acute phase and suitable for early diagnosis of leptospirosis. Leptocheck-WB is suitable as a rapid immunodiagnostic screening test for resource limited settings.

Project description:Melioidosis is a life-threatening disease in humans caused by the Gram-negative bacterium Burkholderia pseudomallei. As severe septicemic melioidosis can lead to death within 24 to 48 h, a rapid diagnosis of melioidosis is critical for ensuring that an optimal antibiotic course is prescribed to patients. Here, we report the development and evaluation of a bacteriophage tail fiber-based latex agglutination assay for rapid detection of B. pseudomallei infection. Burkholderia phage E094 was isolated from rice paddy fields in northeast Thailand, and the whole genome was sequenced to identify its tail fiber (94TF). The 94TF complex was structurally characterized, which involved identification of a tail assembly protein that forms an essential component of the mature fiber. Recombinant 94TF was conjugated to latex beads and developed into an agglutination-based assay (94TF-LAA). 94TF-LAA was initially tested against a large library of Burkholderia and other bacterial strains before a field evaluation was performed during routine clinical testing. The sensitivity and specificity of the 94TF-LAA were assessed alongside standard biochemical analyses on 300 patient specimens collected from an area of melioidosis endemicity over 11 months. The 94TF-LAA took less than 5 min to produce positive agglutination, demonstrating 98% (95% confidence interval [CI] of 94.2% to 99.59%) sensitivity and 83% (95% CI of 75.64% to 88.35%) specificity compared to biochemical-based detection. Overall, we show how a Burkholderia-specific phage tail fiber can be exploited for rapid detection of B. pseudomallei. The 94TF-LAA has the potential for further development as a supplementary diagnostic to assist in clinical identification of this life-threatening pathogen. IMPORTANCE Rapid diagnosis of melioidosis is essential for ensuring that optimal antibiotic courses are prescribed to patients and thus warrants the development of cost-effective and easy-to-use tests for implementation in underresourced areas such as northeastern Thailand and other tropical regions. Phage tail fibers are an interesting alternative to antibodies for use in various diagnostic assays for different pathogenic bacteria. As exposed appendages of phages, tail fibers are physically robust and easy to manufacture, with many tail fibers (such as 94TF investigated here) capable of targeting a given bacterial species with remarkable specificity. Here, we demonstrate the effectiveness of a latex agglutination assay using a Burkholderia-specific tail fiber 94TF against biochemical-based detection methods that are the standard diagnostic in many areas where melioidosis is endemic.

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Comparison of a Lateral Flow Assay and a Latex Agglutination Test for the Diagnosis of Cryptococcus Neoformans Infection.

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