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

J. Bolodeoku., S. Bains, Vivek Chand, R. Bacon, P. Weir, V. Miles, F. Chinegwundoh
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引用次数: 1

Abstract

Background This study evaluated and compared the performance of the i-CHROMA point-of-care testing (POCT) method for the quantification of prostate-specific antigen (PSA) against a traditional laboratory PSA method (Abbott Architect assay). Materials and Method Blood samples (venous [143] serum [143]) and finger prick (55) were collected from volunteers at a PSA screening campaign. Both venous and finger-prick samples were analyzed using the i-CHROMA PSA method and serum samples using the Abbott Architect method. Results were compared using linear regression and Red Amber Green analysis, a scoring system based on volunteer's age and PSA level. Red indicated a raised PSA, amber indicated a slightly raised PSA, and green indicated a normal PSA. Results The data showed that both the i-CHROMA PSA results using the venous samples (r2 = 0.9841) and the finger-prick samples (r2 = 0.90845) showed a good correlation when compared with the serum samples using the laboratory method. The Red Amber Green analysis showed the i-CHROMA' venous PSA method identified 15 reds, 13 ambers, and 115 greens compared with 9 reds, 8 ambers, and 126 greens identified by Abbot Architect method. The i-CHROMA finger-prick PSA method identified 3 reds, 3 ambers, and 49 greens compared with 3 reds, 1 ambers, and 51 greens identified by Abbot Architect method. Conclusions The i-CHROMA POCT PSA method showed good correlation with the Abbott Architect PSA method. Higher numbers of raised and abnormal PSA were identified by the i-CHROMA POCT PSA method due to the positive bias observed. The i-CHROMA POCT PSA method is a reliable method for total PSA within its limitations.
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即时护理测试i-CHROMA前列腺特异性抗原筛查方法在社区中的评价
本研究评估并比较了i-CHROMA护理点检测(POCT)方法定量前列腺特异性抗原(PSA)与传统实验室PSA方法(Abbott Architect assay)的性能。材料与方法在PSA筛查活动中采集志愿者血样(静脉血样[143],血清血样[143])和指刺血样(55)。静脉和手指点刺标本采用i-CHROMA PSA法分析,血清标本采用Abbott Architect法分析。结果使用线性回归和Red Amber Green分析(一种基于志愿者年龄和PSA水平的评分系统)进行比较。红色表示PSA升高,琥珀色表示PSA轻微升高,绿色表示PSA正常。结果静脉标本i-CHROMA PSA检测结果(r2 = 0.9841)和指刺标本i-CHROMA PSA检测结果(r2 = 0.90845)与实验室血清标本i-CHROMA PSA检测结果具有良好的相关性。Red Amber Green分析显示,i-CHROMA'静脉PSA法识别出15种红色、13种琥珀色和115种绿色,而Abbot Architect法识别出9种红色、8种琥珀色和126种绿色。i-CHROMA指刺PSA法鉴定出3个红色、3个琥珀色和49个绿色,而Abbot Architect法鉴定出3个红色、1个琥珀色和51个绿色。结论i-CHROMA POCT PSA法与Abbott Architect PSA法具有良好的相关性。由于观察到阳性偏倚,i-CHROMA POCT PSA方法鉴定出较高数量的升高和异常PSA。i-CHROMA POCT PSA法在其局限性内是一种可靠的总PSA方法。
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