The Accuracy Performance of the Point of Care Test (POCT) Boditech I-CHROMA™ Testosterone Method using External Quality Assessment Schemes: RIQAS and UKNEQAS

Bolodeoku, John; Coker, Olu; Bains, Suman; Anyaeche, C; Kim, TK; Chinegwundoh, Frank

doi:10.34297/ajbsr.2019.04.000859

Cited by 5 publications

(5 citation statements)

References 15 publications

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“…Our previous study determined the performance of the i-CHROMA™ using the RIQAS and UKNEQAS quality control schemes with other PSA methods (Abbott 4000/e411, Beckman DXI standardised to WHO IRP96/670) exhibited a bias in RIQAS that was on the order of −2.99 to +6.8 ng/mL, with an average of +0.88 ng/mL. The UKNQEAS, on the other hand, displayed bias between +0.53 and +2.58 ng/mL, with an average of +1.46 ng/ mL [12]. Over 50% of the RIQAS and UKNEQAS approaches revealed a positive bias greater than 1.0 ng/ mL for all the methods used.…”

Section: Discussionmentioning

confidence: 99%

A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods

Bolodeoku,

Gbaa,

Anyaeche

et al. 2023

J Global Med

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Background: This study evaluated and compared the performance of the Boditech i-CHROMA™ point-of-care testing (POCT) method for the quantification of prostate-specific antigen (PSA) against traditional laboratory PSA method (Roche Methods – Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411) using external quality control material from RIQAS. Materials and method: External quality control distributions from RIQAS were analysed using the Boditech i-CHROMA™ PSA method; these were then compared with the results of the Roche Methods – Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411 provided by participants in the scheme. The mean results of the Roche methods were compared using linear regression and Red Amber Green (RAG) analysis, a scoring system where red is indicative of a raised PSA (>6.0 ng/mL), amber is indicative of a slightly raised PSA (5.0 – 6.0 ng/mL). Green indicates a normal PSA (<5.0 ng/mL). Results: The data showed that between the Boditech i-CHROMA™ PSA results and the Roche Cobas c303/501/502/503, there was an excellent correlation (r2 = 0.9843). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 26 reds, two ambers, and six greens compared with 27 reds, two ambers, and six greens determined by the Roche Cobas c303/501/502/503 method. The data showed an excellent correlation between the Boditech i-CHROMA™ PSA results and the Roche Cobas e402/ e801 PSA methods (r2 = 0.9842). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 30 reds, three ambers, and eight greens compared with 31 reds, two ambers, and eight greens identified by the Roche Cobas e402/ e801 PSA methods. The data showed an excellent correlation between the Boditech i-CHROMA™ PSA results and the Roche Cobas e411 PSA methods (r2 = 0.9851). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 30 reds, three ambers, and eight greens compared with 31 reds, two ambers, and eight greens identified Roche Cobas e411 PSA methods. Conclusion: The data showed that the Boditech i-CHROMA™ PSA method is comparable to the Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411 PSA methods. This could effectively reduce the turnaround time to make prompt decisions on diagnosing, treating, and monitoring of patients with prostate-related disorders.

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Section: Discussionmentioning

confidence: 99%

A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods

Bolodeoku,

Gbaa,

Anyaeche

et al. 2023

J Global Med

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“…The performance of the Boditech iCHROMA with EQA materials from organizations such as the United Kingdom National External Quality Assessment Service (UKNEQAS) and Randox International Quality Assessment Scheme (RIQAS) has been well described with analytes such as human chorionic gonadotrophin (HCG) [7], follicle stimulating hormone (FSH) [7], leutinising hormone (LH) [7], Vitamin D [8], Prostate Specific Antigen (PSA) [9], testosterone [10], ferritin [11]. The detection of SARS-CoV-2 infection is important in the understanding of this infection and the importance of the EQA in harmonizing the various methods of detecting the antibodies is appropriate.…”

Section: Discussionmentioning

confidence: 99%

Performance of the Boditech iCHROMA Covid-19 IgG antibody assay with the external quality control for UK NIBSC (National Institute of Biological Standards and Control)

Bolodeoku¹

2020

CMRR

Self Cite

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Background: There is a need for laboratories to participate in EQA schemes to achieve a harmonization of test results and to improve serological testing and research on COVID-19 and SARS-CoV-2. The Boditech iCHROMA point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG antibodies in human whole blood/serum/plasma. The National Institute for Biological Standards and Control (NIBSC) in the United Kingdom has a portfolio of reference and research reagents, including reagents for EQA that are available to laboratories to help them set up and develop accurate diagnostic tests for SARS-CoV-2 assays. Objectives: To determine the performance of the Boditech iCHROMA Covid-19 IgG antibody assay using the external quality control material provided by the UK NIBSC (National Institute for Biological Standards and Control). Results: The Boditech iCHROMA Covid-19 IgG assay using the cut off index >1.1, reported the results of the 33 positive control samples as positive with index range from 19.50 – 29.00, with a mean of 23.75 and standard deviation of SD of 2.53. It also reported the results of the 33 negative control samples as negative with an index range of 0.00 for all samples. Conclusion: The performance of the Boditech iCHROMA Covid-19 IgG antibody assay using external quality control material from the UK NIBSC was very good, confirming the precision of the Boditech iCHROMA Covid 19 IgG antibody method.

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“…The Abbott AxSYM PSA assay was calibrated using the WHO standard 90/670 as a reference. [13] Linear regression and coefficient of correlation between the two tests yielded the regression equation y = 1.0283x -0.0973 and r = 0.992, respectively. The intra-assay precision was calculated by one evaluator, who tested three different concentrations of control material ten ©Annals of Health Research.…”

Section: Thementioning

confidence: 99%

A Comparative Study of Prostate Specific Antigen (PSA) Point-of-Care-Testing (POCT) Techniques

Ajala

Adedeji²,

Busuyi³

2023

Ann Health Res

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Background: Prostate Specific Antigen (PSA) testing is widely used to diagnose and monitor clinical progress in patients with prostate cancer. The availability of various new Point-of-Care-Testing (POCT) equipment for PSA demands that the performance characteristics of these equipment be assessed before introducing them into clinical use to ensure accuracy and reliability. Objectives: To compare the i-CHROMA® automated immunofluorescence serum total PSA assay with the Accubind® Enzyme Linked Immuno-Sorbent Assay (ELISA) as POCT among patients with suspected prostate cancer. Methods: The study was conducted at the Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Nigeria. Blood samples drawn from 20 consecutively selected patients were analysed for PSA using the i-CHROMA® immunofluorescence kit once and with the Accubind® ELISA protocol twice. Results: The mean PSA using Accubind® ELISA was 12.9ng/ml, while it was 14.5ng/ml with the i-CHROMA® immunofluorescence assay. The bias between the two methods was 1.6ng/ml. The two methods had a good correlation: Passing Bablok regression equation was y = 1.264604x – 0.0300469, and the Spearman correlation coefficient between the two measurements was high (r = 0.956; Confidence Interval 0.889 - 0.983; p<0.0001). Agreement between the two methods was statistically satisfactory as the mean values of the samples fell within the 95% Confidence Interval of the differences on the Bland Altman plot. Conclusion: The i-CHROMA® POCT assay showed good correlation and agreement with the well-known ELISA method. Therefore, the method is recommended for use in monitoring PSA in patients with prostatic cancer.

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The Accuracy Performance of the Point of Care Test (POCT) Boditech I-CHROMA™ Testosterone Method using External Quality Assessment Schemes: RIQAS and UKNEQAS

Abstract: This work is licensed under Creative Commons Attribution 4.0 License AJBSR.MS.ID.000859.

Cited by 5 publications

References 15 publications

A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods

A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods

Performance of the Boditech iCHROMA Covid-19 IgG antibody assay with the external quality control for UK NIBSC (National Institute of Biological Standards and Control)

A Comparative Study of Prostate Specific Antigen (PSA) Point-of-Care-Testing (POCT) Techniques

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