Diagnostic accuracy of the InBiOS AMD rapid diagnostic test for the detection of Burkholderia pseudomallei antigen in grown blood culture broth

Peeters, Marjan; Chung, Panha; Lin, Hua; Mortelmans, Kristien; Phe, Chhundy; San, Chentha; Kuijpers, Laura Maria Francisca; Teav, Syna; Phe, Thong; Jacobs, Jan

doi:10.1007/s10096-018-3237-3

Cited by 22 publications

(16 citation statements)

References 37 publications

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“…A number of simple direct tests have been described. Examples are detection of Staphylococcus aureus by direct tube coagulase test for detection of Staphylococcus aureus (271, 272), latex agglutination tests (273) and immunochromatographic tests (274), and the recent development of lateral flow assays for Burkholderia pseudomallei (275) and Salmonella species (276).…”

Section: Challengesmentioning

confidence: 99%

Best Practices of Blood Cultures in Low- and Middle-Income Countries

et al. 2019

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Bloodstream infections (BSI) have a substantial impact on morbidity and mortality worldwide. Despite scarcity of data from many low- and middle-income countries (LMICs), there is increasing awareness of the importance of BSI in these countries. For example, it is estimated that the global mortality of non-typhoidal Salmonella bloodstream infection in children under 5 already exceeds that of malaria. Reliable and accurate diagnosis of these infections is therefore of utmost importance. Blood cultures are the reference method for diagnosis of BSI. LMICs face many challenges when implementing blood cultures, due to financial, logistical, and infrastructure-related constraints. This review aims to provide an overview of the state-of-the-art of sampling and processing of blood cultures, with emphasis on its use in LMICs. Laboratory processing of blood cultures is relatively straightforward and can be done without the need for expensive and complicated equipment. Automates for incubation and growth monitoring have become the standard in high-income countries (HICs), but they are still too expensive and not sufficiently robust for imminent implementation in most LMICs. Therefore, this review focuses on “manual” methods of blood culture, not involving automated equipment. In manual blood cultures, a bottle consisting of a broth medium supporting bacterial growth is incubated in a normal incubator and inspected daily for signs of growth. The collection of blood for blood culture is a crucial step in the process, as the sensitivity of blood cultures depends on the volume sampled; furthermore, contamination of the blood culture (accidental inoculation of environmental and skin bacteria) can be avoided by appropriate antisepsis. In this review, we give recommendations regarding appropriate blood culture sampling and processing in LMICs. We present feasible methods to detect and speed up growth and discuss some challenges in implementing blood cultures in LMICs, such as the biosafety aspects, supply chain and waste management.

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Section: Challengesmentioning

confidence: 99%

Best Practices of Blood Cultures in Low- and Middle-Income Countries

et al. 2019

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“…Recently, a qualitative, membrane-based lateral flow immunoassay point-of-care test (POCT) that detects the capsular polysaccharide of B. pseudomallei , the Active Melioidosis Detect™ (AMD), has been developed by InBios (Seattle, WA, USA) 13 . The AMD has undergone a small number of evaluations for the direct detection of B. pseudomallei in a range of clinical samples 12–17 as well as for the detection of the organism in blood culture broths 15 , 18 . Such a test, which is easy to use and relatively cheap, could prove a very valuable tool in resource-limited settings.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Active Melioidosis Detect™ test as a point-of-care tool for the early diagnosis of melioidosis: a comparison with culture in Laos

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Bouthasavong

et al. 2019

Transactions of the Royal Society of Tropical Medicine and Hygiene

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Background Melioidosis is difficult to diagnose clinically and culture of Burkholderia pseudomallei is the current, imperfect gold standard. However, a reliable point-of-care test (POCT) could enable earlier treatment and improve outcomes. Methods We evaluated the sensitivity and specificity of the Active Melioidosis Detect™ (AMD) rapid test as a POCT and determined how much it reduced the time to diagnosis compared with culture. Results We tested 106 whole blood, plasma and buffy coat samples, 96 urine, 28 sputum and 20 pus samples from 112 patients, of whom 26 (23.2%) were culture-positive for B. pseudomallei. AMD sensitivity and specificity were 65.4 and 87.2%, respectively, the latter related to 10 weak positive reactions on urine samples, considered likely false positives. The positive predictive value was 60.7%, negative predictive value was 89.3% and concordance rate between operators reading the test was 95.7%; time to diagnosis decreased by a median of 23 h. Conclusions Our findings confirm that a strongly positive AMD result can reduce the time to diagnosis of melioidosis. However, the AMD currently has a disappointing overall sensitivity, especially with blood fractions, and specificity problems when testing urine samples.

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“…Moreover, in the case of a very high antigen concentration (a limited number of antibodies faced with a very large number of antigen molecules), the antigen–antibody reaction may have shown less signal, which can lead to false negative or weakly positive results, the so-called “hook” effect or “prozone” effect (as shown in Figure 4 ). To overcome this problem, the suspected sample should be adequately diluted before testing the LFIA or use real-time reaction kinetics for the detection [ 39 , 40 ]. In addition, false negative results may have been due to the small amount of protein A produced by some individual S. aureus strains.…”

Section: Discussionmentioning

confidence: 99%

Development of a Prototype Lateral Flow Immunoassay for Rapid Detection of Staphylococcal Protein A in Positive Blood Culture Samples

et al. 2020

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Bloodstream infection (BSI) is a major cause of mortality in hospitalized patients worldwide. Staphylococcus aureus is one of the most common pathogens found in BSI. The conventional workflow is time consuming. Therefore, we developed a lateral flow immunoassay (LFIA) for rapid detection of S. aureus-protein A in positive blood culture samples. A total of 90 clinical isolates including 58 S. aureus and 32 non-S. aureus were spiked in simulated blood samples. The antigens were extracted by a simple boiling method and diluted before being tested using the developed LFIA strips. The results were readable by naked eye within 15 min. The sensitivity of the developed LFIA was 87.9% (51/58) and the specificity was 93.8% (30/32). When bacterial colonies were used in the test, the LFIA provided higher sensitivity and specificity (94.8% and 100%, respectively). The detection limit of the LFIA was 107 CFU/mL. Initial evaluation of the LFIA in 20 positive blood culture bottles from hospitals showed 95% agreement with the routine methods. The LFIA is a rapid, simple and highly sensitive method. No sophisticated equipment is required. It has potential for routine detection particularly in low resource settings, contributing an early diagnosis that facilitates effective treatment and reduces disease progression.

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Diagnostic accuracy of the InBiOS AMD rapid diagnostic test for the detection of Burkholderia pseudomallei antigen in grown blood culture broth

Cited by 22 publications

References 37 publications

Best Practices of Blood Cultures in Low- and Middle-Income Countries

Best Practices of Blood Cultures in Low- and Middle-Income Countries

Evaluation of the Active Melioidosis Detect™ test as a point-of-care tool for the early diagnosis of melioidosis: a comparison with culture in Laos

Development of a Prototype Lateral Flow Immunoassay for Rapid Detection of Staphylococcal Protein A in Positive Blood Culture Samples

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