Sensitivity and specificity of a lateral flow immunoassay (LFI) in serum samples for diagnosis of melioidosis

Wongsuvan, Gumphol; Hantrakun, Viriya; Teparrukkul, Prapit; Imwong, Mallika; West, T. Eoin; Wuthiekanun, Vanaporn; Day, Nicholas P. J.; AuCoin, David P.; Limmathurotsakul, Direk

doi:10.1093/trstmh/try099

Cited by 16 publications

(25 citation statements)

References 8 publications

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“…We previously demonstrated that the CPS-LFI had limited sensitivity (31.3%) but high specificity (98.8%) for diagnosing melioidosis among patients presenting with community-acquired infections or sepsis in northeast Thailand when stored serum were tested [ 15 ]. Here, we evaluated combinations of the CPS-LFI and Hcp1- or OPS-ELISA for diagnosis of melioidosis.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of antigen-detecting and antibody-detecting diagnostic test combinations for diagnosing melioidosis

et al. 2021

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Background Melioidosis, an infectious disease caused by Burkholderia pseudomallei, is endemic in many tropical developing countries and has a high mortality. Here we evaluated combinations of a lateral flow immunoassay (LFI) detecting B. pseudomallei capsular polysaccharide (CPS) and enzyme-linked immunosorbent assays (ELISA) detecting antibodies against hemolysin co-regulated protein (Hcp1) or O-polysaccharide (OPS) for diagnosing melioidosis. Methodology/Principal findings We conducted a cohort-based case-control study. Both cases and controls were derived from a prospective observational study of patients presenting with community-acquired infections and sepsis in northeast Thailand (Ubon-sepsis). Cases included 192 patients with a clinical specimen culture positive for B. pseudomallei. Controls included 502 patients who were blood culture positive for Staphylococcus aureus, Escherichia coli or Klebsiella pneumoniae or were polymerase chain reaction assay positive for malaria or dengue. Serum samples collected within 24 hours of admission were stored and tested using a CPS-LFI, Hcp1-ELISA and OPS-ELISA. When assessing diagnostic tests in combination, results were considered positive if either test was positive. We selected ELISA cut-offs corresponding to a specificity of 95%. Using a positive cut-off OD of 2.912 for Hcp1-ELISA, the combination of the CPS-LFI and Hcp1-ELISA had a sensitivity of 67.7% (130/192 case patients) and a specificity of 95.0% (477/502 control patients). The sensitivity of the combination (67.7%) was higher than that of the CPS-LFI alone (31.3%, p<0.001) and that of Hcp1-ELISA alone (53.6%, p<0.001). A similar phenomenon was also observed for the combination of CPS-LFI and OPS-ELISA. In case patients, positivity of the CPS-LFI was associated with a short duration of symptoms, high modified Sequential (sepsis-related) Organ Failure Assessment (SOFA) score, bacteraemia and mortality outcome, while positivity of Hcp1-ELISA was associated with a longer duration of symptoms, low modified SOFA score, non-bacteraemia and survival outcome. Conclusions/Significance A combination of antigen-antibody diagnostic tests increased the sensitivity of melioidosis diagnosis over individual tests while preserving high specificity. Point-of-care tests for melioidosis based on the use of combination assays should be further developed and evaluated.

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Section: Introductionmentioning

confidence: 99%

Evaluation of antigen-detecting and antibody-detecting diagnostic test combinations for diagnosing melioidosis

et al. 2021

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“…Finally, rapid diagnostic lateral flow immunoassays (LFI) have been developed for use in laboratory settings where molecular and ELISA methods are generally not available. The Active Melioidosis Detect LFI (InBios International Inc., USA) detects soluble B. pseudomallei capsular polysaccharide and has high sensitivity and specificity (98.7% and 97.2%, respectively) when tested against B. pseudomallei isolates (17) but performs poorly when used with urine and blood samples (17)(18)(19). A recent study in Laos demonstrated that this LFI had high specificity when testing turbid blood culture bottles (100%), pus (100%), sputum (100%), sterile fluid (100%), and urine (90.7%).…”

Section: Discussionmentioning

confidence: 99%

“…Latex agglutination using beads conjugated with B. pseudomallei-specific monoclonal antibodies could identify bacterial colonies isolated from clinical samples at a high sensitivity (99.1%) with a reduced time to report (16). An immunochromatography assay using capsule polysaccharide-specific monoclonal antibody to detect bacterial components had reasonable specificity (93.6%) but low sensitivity (85.7%) (17,18), particularly when applied to blood samples (31.3% sensitivity) (19). PCR detection of the T3SS gene cluster provides Ͼ80% sensitivity (20), but direct detection of bacteria in clinical specimens is problematic, as pathogen concentrations are generally very low (21).…”

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confidence: 99%

Adapting Microarray Gene Expression Signatures for Early Melioidosis Diagnosis

et al. 2020

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Melioidosis is caused by Burkholderia pseudomallei and is predominantly seen in tropical regions. The clinical signs and symptoms of the disease are nonspecific and often result in misdiagnosis, failure of treatment, and poor clinical outcome. Septicemia with septic shock is the most common cause of death, with mortality rates above 40%. Bacterial culture is the gold standard for diagnosis, but it has low sensitivity and takes days to produce definitive results. Early laboratory diagnosis can help guide physicians to provide treatment specific to B. pseudomallei. In our study, we adapted host gene expression signatures obtained from microarray data of B. pseudomallei-infected cases to develop a real-time PCR diagnostic test using two differentially expressed genes, AIM2 (absent in melanoma 2) and FAM26F (family with sequence similarity 26, member F). We tested blood from 33 patients with B. pseudomallei infections and 29 patients with other bacterial infections to validate the test and determine cutoff values for use in a cascading diagnostic algorithm. Differentiation of septicemic melioidosis from other sepsis cases had a sensitivity of 82%, specificity of 93%, and negative and positive predictive values (NPV and PPV) of 82% and 93%, respectively. Separation of cases likely to be melioidosis from those unlikely to be melioidosis in nonbacteremic situations showed a sensitivity of 40%, specificity of 54%, and NPV and PPV of 44% and 50%, respectively. We suggest that our AIM2 and FAM26F expression combination algorithm could be beneficial for early melioidosis diagnosis, offering a result within 24 h of admission.

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“…The AMD-LFA, which detects B. pseudomallei 6-deoxyheptan capsular polysaccharide antigen, has been specifically developed for resource-poor, melioidosis-endemic settings where B. pseudomallei culture is frequently not available. 25 It has been evaluated on blood culture broths in Cambodia and Laos 26 and directly on clinical samples in Australia, 27 Laos, 28 , 29 Thailand 30 and India. 31 Shaw et al 31 demonstrated an overall sensitivity of 86% (CI 75 to 93) and specificity of 94% (CI 88 to 97) with a positive predictive value of 86% (CI 76 to 92) compared with culture on multiple types of specimens.…”

Section: Discussionmentioning

confidence: 99%

Observational study of adult respiratory infections in primary care clinics in Myanmar: understanding the burden of melioidosis, tuberculosis and other infections not covered by empirical treatment regimes

Warrell

Phyo

Win

et al. 2021

Transactions of the Royal Society of Tropical Medicine and Hygiene

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Background Lower respiratory infections constitute a major disease burden worldwide. Treatment is usually empiric and targeted towards typical bacterial pathogens. Understanding the prevalence of pathogens not covered by empirical treatment is important to improve diagnostic and treatment algorithms. Methods A prospective observational study in peri-urban communities of Yangon, Myanmar was conducted between July 2018 and April 2019. Sputum specimens of 299 adults presenting with fever and productive cough were tested for Mycobacterium tuberculosis (microscopy and GeneXpert MTB/RIF [Mycobacterium tuberculosis/resistance to rifampicin]) and Burkholderia pseudomallei (Active Melioidosis Detect Lateral Flow Assay and culture). Nasopharyngeal swabs underwent respiratory virus (influenza A, B, respiratory syncytial virus) polymerase chain reaction testing. Results Among 299 patients, 32% (95% confidence interval [CI] 26 to 37) were diagnosed with tuberculosis (TB), including 9 rifampicin-resistant cases. TB patients presented with a longer duration of fever (median 14 d) and productive cough (median 30 d) than non-TB patients (median fever duration 6 d, cough 7 d). One case of melioidosis pneumonia was detected by rapid test and confirmed by culture. Respiratory viruses were detected in 16% (95% CI 12 to 21) of patients. Conclusions TB was very common in this population, suggesting that microscopy and GeneXpert MTB/RIF on all sputum samples should be routinely included in diagnostic algorithms for fever and cough. Melioidosis was uncommon in this population.

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Sensitivity and specificity of a lateral flow immunoassay (LFI) in serum samples for diagnosis of melioidosis

Cited by 16 publications

References 8 publications

Evaluation of antigen-detecting and antibody-detecting diagnostic test combinations for diagnosing melioidosis

Evaluation of antigen-detecting and antibody-detecting diagnostic test combinations for diagnosing melioidosis

Adapting Microarray Gene Expression Signatures for Early Melioidosis Diagnosis

Observational study of adult respiratory infections in primary care clinics in Myanmar: understanding the burden of melioidosis, tuberculosis and other infections not covered by empirical treatment regimes

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