External quality assessment scheme for parasite serology; a review of the scheme design and performance

Collier, Sophie; Manser, M.; Chiodini, Peter L.

doi:10.1136/jcp.2009.071597

Cited by 6 publications

(6 citation statements)

References 9 publications

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“…Obviously, assay verification and validation are critical steps when implementing diagnostic tests. In particular for antibody detection methods and NAATs, both having a large diversity of assays available, successful participation in an external quality assessment scheme (EQAS) is essential to obtain the highest achievable diagnostic quality (67,68). Overall, in-house tests require more quality control measurements than commercial tests and they suffer more from variation in test-performance, as well as lack of availability.…”

Section: Diagnostic Proceduresmentioning

confidence: 99%

Context-Specific Procedures for the Diagnosis of Human Schistosomiasis – A Mini Review

Hoekstra¹,

Dam²,

Lieshout³

2021

Front. Trop. Dis

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Schistosomiasis is a parasitic disease caused by trematode blood flukes of the genus Schistosoma, affecting over 250 million people mainly in the tropics. Clinically, the disease can present itself with acute symptoms, a stage which is relatively more common in naive travellers originating from non-endemic regions. It can also develop into chronic disease, with the outcome depending on the Schistosoma species involved, the duration and intensity of infection and several host-related factors. A range of diagnostic tests is available to determine Schistosoma infection, including microscopy, antibody detection, antigen detection using the Point-Of-Care Circulating Cathodic Antigen (POC-CCA) test and the Up-Converting Particle Lateral Flow Circulating Anodic Antigen (UCP-LF CAA) test, as well as Nucleic Acid Amplification Tests (NAATs) such as real-time PCR. In this mini review, we discuss these different diagnostic procedures and explore their most appropriate use in context-specific settings. With regard to endemic settings, diagnostic approaches are described based on their suitability for individual diagnosis, monitoring control programs, determining elimination as a public health problem and eventual interruption of transmission. For non-endemic settings, we summarize the most suitable diagnostic approaches for imported cases, either acute or chronic. Additionally, diagnostic options for disease-specific clinical presentations such as genital schistosomiasis and neuro-schistosomiasis are included. Finally, the specific role of diagnostic tests within research settings is described, including a controlled human schistosomiasis infection model and several clinical studies. In conclusion, context-specific settings have different requirements for a diagnostic test, stressing the importance of a well-considered decision of the most suitable diagnostic procedure.

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Section: Diagnostic Proceduresmentioning

confidence: 99%

Context-Specific Procedures for the Diagnosis of Human Schistosomiasis – A Mini Review

Hoekstra¹,

Dam²,

Lieshout³

2021

Front. Trop. Dis

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“…The trial samples: The purpose of creating the trial samples with different concentrations of antibodies is to enhance the efficiency of quality assessment of participating laboratories. In comparison with other studies such as "External quality assessment scheme for parasite serology; a review of the scheme design and performance" by Collier [2], and "The United Kingdom National External Quality Assessment Service for parasitology: toxoplasma serology scheme" by Manser [5], in the EQA scheme of serological testing for Toxoplasma sp. in England, there is a bias at low concentrations.…”

Section: Determination Of Quality Of the Trial Samples Containing An mentioning

confidence: 99%

“…It plays a key role in the control and evaluation of the quality of a laboratory via interlaboratory comparisons. EQA participation is vital for all medical laboratories [2]. At present, there is no study on production of trial samples for specific serodiagnosis of anti-Fasciola gigantica antibodies for EQA.…”

Section: Introductionmentioning

confidence: 99%

Development and Testing of Trial Samples for Specific Serodiagnosis of Fasciola gigantica via External Quality Assessment

Huy¹,

Trung²,

Tuan³

et al. 2019

J Bacteriol Parasitol

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Objective: To build a procedure for production of samples for specific serodiagnosis of anti-Fasciola gigantica antibodies via an external quality assessment scheme, and to evaluate the homogeneity and stability of the trial samples. Methods: In this experimental study, samples contained an anti-Fasciola gigantica antibody according to screening by ELISA, followed by confirmation by Western blotting were collected. All samples were tested and found negative for other helminth, especially of trematode antibodies. The samples were also negative for anti-HIV-1 and-2 antibodies, anti-HCV antibodies, and HBs antigen. The samples were prepared by freeze-drying and freezing methods, the stability and homogeneity were evaluated each 2, 4, 8, 12 and up to 24 weeks. Results: We produced three lots of serum samples containing anti-Fasciola gigantica antibodies at three levels. Lot DK1 had optical density, OD=0.350 ± 0.037; Lots DK3 and DL3 had O=0.653 ± 0.046, and Lot DL1 had OD=0.850 ± 0.047 with the wavelength of 450 nm. The specific IgG antibodies against Fasciola gigantica antigens were found to be positive for all three proteins, 8-9 kDa protein (P 8-9), 28 kDa (P 28), and 42 kDa (P 42) by the Western blot technique. The trial samples were confirmed to be homogeneous by Fisher's test (F statistics0.05) as well as to be stable during 24 weeks (with t statistics0.05). Conclusion: Trial samples for specific serodiagnosis of anti-Fasciola gigantica antibodies via external quality assessment can be produced with homogeneity and stability lasting for 24 weeks by freeze-drying and freezing methods.

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“…The specific serodiagnosis of anti-Toxocara canis antibodies for EQA was designed to improve the quality of screening and diagnostic tests for Toxocara canis, which plays a key role in the control and evaluation of the quality of a laboratory via interlaboratory comparisons. EQA participation is vital for all medical laboratories [6]. A report on the quality of laboratories performing serological diagnosis of Toxoplasma sp.…”

Section: Introductionmentioning

confidence: 99%

Establishment of an Experimental Procedure for Preparing Trial Serum Samples for the Specific Serodiagnosis of Toxocara canis for External Quality Assessment Schemes

Tran

et al. 2020

Journal of Parasitology Research

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Background. External quality assessment (EQA) provides evidence of reliable, accurate, and precise results for customers using the diagnostic test for Toxocara canis. Objective. To establish a procedure for producing standard Toxocara canis serum samples for serodiagnostic testing in EQA. Methods. The collected serum samples to contain anti-Toxocara canis antibodies were screened by ELISA and confirmed by Western blotting. These samples were found to be negative for other helminth antibodies, anti-HIV-1 and -2 antibodies, anti-HCV antibodies, and antibodies to HBs antigen. The sera were divided, processed by both freeze-drying and freezing methods, and then stored. The stability and homogeneity of the samples were evaluated after 7 days, 1 month, 3 months, and 6 months. An F-test and a T-test were applied to evaluate their homogeneity and stability. Results. Among eleven samples positive by ELISA, ten of them were confirmed via Western blotting by positive reaction with 5 specific Toxocara canis bands. Two lots of trial standard sera containing specific anti-Toxocara canis antibodies were successfully produced. Lot DK had a concentration of 31.01±1.1 NovaTec Units (NTU), and Lot DL had a concentration of 27.18±0.9 NTU. After storage at -80°C, the samples prepared by the freeze-drying method were stable for at least 3 months, and the samples prepared by the freezing method were stable for 6 months (p>0.05). Samples produced by both methods were stable for 7 days at 30°C (p>0.05). Conclusion. Specific serodiagnosis samples of anti-Toxocara canis antibodies for EQA could be produced that possessed homogeneity and stability lasting for 3 months and 6 months by the freeze-drying and freezing methods, respectively. At 30°C, the samples produced by both methods were stable for 7 days, suitable for delivery to remote laboratories.

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External quality assessment scheme for parasite serology; a review of the scheme design and performance

Abstract: It is hoped that this scheme will lead to a more standardised approach to the serological diagnosis of parasitic infection.

Cited by 6 publications

References 9 publications

Context-Specific Procedures for the Diagnosis of Human Schistosomiasis – A Mini Review

Context-Specific Procedures for the Diagnosis of Human Schistosomiasis – A Mini Review

Development and Testing of Trial Samples for Specific Serodiagnosis of Fasciola gigantica via External Quality Assessment

Establishment of an Experimental Procedure for Preparing Trial Serum Samples for the Specific Serodiagnosis of Toxocara canis for External Quality Assessment Schemes

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