An Evaluation of the Point-of-Care Test i-CHROMA Prostate-Specific Antigen Method for Screening in the Community

Bolodeoku, John; Bains, Suman; Chand, Vivek; Bacon, Roger John; Weir, Patricia M.; Miles, Vivian; Chinegwundoh, Frank

doi:10.1097/poc.0000000000000131

Cited by 8 publications

(9 citation statements)

References 5 publications

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“…Molecular tests are generally not suited for public health screening, antibody tests are more suited and the more portable, the better. A very versatile point of care immunoassay analyser, the Boditech iCHROMA™ has been shown to compare very well with traditional laboratory methods for PSA, Vitamin D, HCG, FSH, LH, TSH, Testosterone, CRP, Microalbumin and Ferritin [3][4][5][6][7][8][9][10]. Recently, Boditech launched a Fluorescence Immunoassay (FIA) for the qualitative determination of IgG/IgM antibodies against "Novel Coronavirus" in human whole blood, serum, and plasma.…”

Section: Introductionmentioning

confidence: 99%

Immune Checkpoint Inhibitors Therapy in Prostate Cancer: Lessons Learnt

Chandok¹

2020

AII

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Background:The Boditech iCHROMA™ point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG/IgM antibodies in human whole blood/serum/plasma. It is helpful as an aid in the screening of early mild asymptomatic or acute patients for identifying Covid-19 infection with high sensitivity.Objectives: To determine the clinical agreement (sensitivity and specificity) of the Boditech iCHROMA™ Covid-19 antibody assay and the Abbott Architect SARS-CoV-2 IgG assay for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.Results: Of the 50 plasma samples, 20 (40%) of the plasma samples assayed were reported as positive by both the Abbott Architect SARS-CoV-2 IgG assay and the Boditech iCHROMA™ Covid-19 IgG antibody assay. The remaining 30 (60%) of the plasma samples were reported as negative by Abbott Architect SARS-CoV-2 IgG antibody assay. However, the Boditech iCHROMA™ Covid-19 IgG antibody assay, reported only 27 of the 30 (90%) samples as negative. Conclusion:There was an overall agreement of 95%, with a sensitivity of 100% and a specificity of 90% of the Boditech iCHROMA™ Covid-19 IgG antibody assay and the Abbott Architect SARS-CoV-2 IgG assay.

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Section: Introductionmentioning

confidence: 99%

Immune Checkpoint Inhibitors Therapy in Prostate Cancer: Lessons Learnt

Chandok¹

2020

AII

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“…More recently, there have been a couple of point of care testing (POCT) methods for quantitatively estimating testosterone methods such as OPKO Claros and the Boditech i-CHROMA™ introduced into the market. We have extensively evaluated the comparative performance of the Boditech i-CHROMA™ for estimating Prostate Specific Antigen (PSA) [10][11][12], Vitamin D [13], Human Chorionic Gonadotrophin (HCG)14, Luteinizing Hormone (LH) [14], Follicle Stimulating Hormone (FSH) [14], C-Reactive Protein (CRP) [15], Microalbumin [15] and TSH [16] and found a very good correlation with other traditional laboratory methods. In this study, we set out to evaluate the performance of the Boditech i-CHROMA™ Testosterone method and compared it with a wide range of testosterone methods enrolled in the Randox International Quality Assessment Scheme (RIQAS) and the United Kingdom National External Quality Assessment Services (UKNEQAS).…”

Section: Introductionmentioning

confidence: 99%

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

Bolodeoku¹,

Coker²,

Bains³

et al. 2019

AJBSR

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“…Furthermore, none of these POCT PSA tests satisfied the acceptable performance criteria for use when testing asymptomatic men as part of the NHS Prostate Cancer Risk Management Programme [7]. There have been recent developments in quantitative POCT PSA methods such as the FREND™ PSA Plus [8], the OPKO 4Kscore® Test [9] and the i-CHROMA™ PSA system [10]. The performance of some of these analysers has been evaluated in the literature in a small number of publications.…”

Section: Introductionmentioning

confidence: 99%

An Evaluation of the Novel i-CHROMA™ Point-of-Care Testing (POCT) Method for the Analysis of Prostate-Specific Antigen (PSA) in Serum

Bolodeoku¹

2018

BJSTR

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Objectives: A reliable point-of-care testing (POCT) method for the quantitation of prostate-specific antigen (PSA) may offer considerable benefits to prostate cancer patients who are undergoing expectant management in a primary care setting. The i-CHROMA™ POCT method for the analysis of PSA is a novel fluorescence-based immunoassay that provides quantitative analysis of total PSA in serum, plasma or whole blood. The aim of this study was to evaluate the performance of the i-CHROMA™ POCT PSA method for the analysis of serum.Design and Methods: Serum samples (n = 54) received for PSA measurement were analysed using the routine laboratory method (Cobas® e602 Total PSA assay) and the i-CHROMA™ POCT PSA method. Results:The data showed that overall, the i-CHROMA™ PSA method showed good correlation with the Cobas® PSA method (r2 = 0.9664). Results within the range of 2 -10 µg/L showed a statistically significant mean positive bias of 7% (0.4 µg/L) on the i-CHROMA™ compared to the Cobas® method, however this bias was found to be higher in the 0.1 -2 and 10 -100 µg/L ranges. Inter-assay precision, assessed by replicate analysis of pooled serum samples (n = 8), was 6% and 5% at concentrations of 4 and 18µg/L respectively. Performance was poorer in the lower range, with precision of 19% at a concentration of 1.8 µg/L. Other practical aspects of the method, e.g. importance of accurate reaction timing, were also assessed and found to be acceptable for use. Conclusion:In summary, the i-CHROMA™ POCT PSA method provides a reliable measurement of total PSA in serum samples within the range of 2 -100 µg/L.

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An Evaluation of the Point-of-Care Test i-CHROMA Prostate-Specific Antigen Method for Screening in the Community

Cited by 8 publications

References 5 publications

Immune Checkpoint Inhibitors Therapy in Prostate Cancer: Lessons Learnt

Immune Checkpoint Inhibitors Therapy in Prostate Cancer: Lessons Learnt

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

An Evaluation of the Novel i-CHROMA™ Point-of-Care Testing (POCT) Method for the Analysis of Prostate-Specific Antigen (PSA) in Serum

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