Evaluation of a newly developed quantitative determination kit for tumor marker CA15‐3 with chemiluminescent assay

Abstract

BackgroundTumor marker carbohydrate antigen 15‐3 (CA15‐3) is used as a biomarker to aid to diagnose and monitor the prognosis of breast cancer patients. A new quantitative determination kit for CA15‐3 with chemiluminescent assay was developed by Xiamen InnoDx Biotech Co., Ltd, China. Therefore, we conducted the report to evaluate the performance of the kit.MethodsAccording to the “Guiding principles on performance analysis of diagnostic reagents in vitro”, the calibration curve, limit of detection, reportable range, accuracy, precision, anti‐interference capability, cross‐reaction and comparison by measuring EDTA plasma and serum were carried out. In addition, the kit was performed in parallel to electrochemiluminescence immunoassay kit (Roche) to analyze the correlation between the two kits.ResultsRegression equation of calibration curve of the kit was Y=0.7914X+4.1032 (R2=.990). Limit of detection was 0.0347 U/mL. The reportable range was 0.5‐2400 U/mL. Recovery ratio was 100.0%‐104.8%. Coefficient of variations (CVs) of within‐run and between‐run were 4.8%‐7.6% and 5.8%‐7.4% respectively. No remarkable interferences (all Bias% were less than ±10%) were detected when samples contained hemoglobin ≤183.8 μmol/L, bilirubin ≤340 μmol/L, triglyceride ≤18.1 mmol/L, or rheumatoid factor ≤400 U/mL. No cross‐reaction was present in the kit. Moreover, compared with the results from electrochemiluminescence immunoassay kit (Roche) in 345 serum samples, there was a satisfied correlation coefficient of 0.977 (P<.01), and the kit was simultaneously fit for the detection of EDTA plasma and serum samples.ConclusionThe new kit validated satisfactorily, and it can be used for detecting CA15‐3 in clinical practice.

Correlation between salivary and serum CA15‑3 concentrations in patients with breast cancer

“…Relative luminescence intensity was determined using a photomultiplier, in relative light units (RLU), being proportional to the amount of CA15-3 present in the sample, and the results were expressed as U/ml. The assay limit of detection for CA15-3 is 1.0 U/ml (14).…”

“…Enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECLIA), and chemiluminescence (CLIA) are the methods typically used to assess serum levels of CA15-3 (13,14). For evaluating salivary levels of CA15-3, the most frequently reported method is ELISA (13) and there are no reports of the application of CLIA or ECLIA.…”

An electrochemically synthesized molecularly imprinted polymer for highly selective detection of breast cancer biomarker CA 15-3: a promising point-of-care biosensor

“…On such a basis, much attention has been devoted to developing procedures to detect the presence of CA 15-3 protein at very low concentrations in a physiological environment and biological uids. 8 Currently, detection of the CA 15-3 biomarker is oen carried out using immunoassays that employ various signal transduction approaches, such as ELISA, 10,11 ow uorescence, 12 chemiluminescence, 13,14 electrochemiluminescence, 15,16 and electrochemistry. 17,18 Although these biosensors are highly selective due to the use of corresponding natural biomolecules such as enzymes, antibodies, aptamers, and lectins, they oen present problems of high cost, tendency to denature, and low abundance.…”