Performance characteristics of the BRAHMS KRYPTOR automated squamous cell carcinoma antigen assay

Fatica, Erica; Larson, Bethany J.; Algeciras‐Schimnich, Alicia; Bornhorst, Joshua A.

doi:10.1016/j.jim.2022.113257

Cited by 3 publications

(3 citation statements)

References 31 publications

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“…Nevertheless, a considerable scatter of single values is observed, particularly for CA 19-9, CA 125 and CA 15-3, which are the methods without an international standard available for calibration [28]. This is in line with earlier method comparison studies on these markers using routine laboratory methods [23,24], and studies consistently identifying notable systematic discrepancies across various systems [29][30][31][32][33][34]. Zur et al [23] conducted a method comparison between the Immulite 200 XPI, Siemens Healthcare and the Dimension Vista 1500 immunoassay (Siemens).…”

Section: Discussionsupporting

confidence: 74%

Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms

Schröder,

Mallmann,

Domroese

et al. 2023

Diagnostics

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Tumor marker determinations are valuable tools for the guidance of breast cancer patients during the course of disease. They are assessed on diverse analytical platforms that may be associated with differences according to the methods applied and the clinical performance. To investigate the method dependency and clinical significance of breast cancer protein tumor markers, CEA, CA 15-3, CA 125, CA 19-9 and AFP were measured in a total of 154 biobanked samples from 77 patients with breast cancer, 10 with DCIS, 31 with benign breast diseases and 36 healthy controls using a Millipore multiplex biomarker panel (MP) and an automized version of the routinely used Vista LOCI technology. The markers were compared between methods and investigated for diagnostic performance. CEA, CA 15-3 and AFP showed good correlations between both platforms with correlation coefficients of R = 0.85, 0.85 and 0.92, respectively, in all samples, but similarly also in the various subgroups. CA 125 and CA 19-9 showed only moderate correlations (R = 0.71 and 0.56, respectively). Absolute values were significantly higher for CEA, CA 15-3, CA 125 and AFP in the Vista LOCI as compared with the MP method and vice versa for CA 19-9. The diagnostic performance for discrimination of breast cancer from healthy controls was similar for both methods with AUCs in ROC curves for CEA (MP 0.81, 95% CI 0.72–0.91; LOCI 0.81; 95% CI 0.72–0.91) and CA-15-3 (MP 0.75, 95% CI 0.65–0.86; LOCI 0.67, 95% CI 0.54–0.79). Similar results were obtained for the comparison of breast cancer with benign breast diseases regarding CEA (AUC MP 0.62, 95% CI 0.51–0.73; LOCI 0.64, 95% CI 0.53–0.74) and CA-15-3 (MP 0.70, 95% CI 0.6–0.81; LOCI 0.66, 95% CI 0.54–0.77). Both platforms show moderate to good method comparability for tumor markers with similar clinical performance. However, absolute levels in individual patients should be interpreted with care.

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Section: Discussionsupporting

confidence: 74%

Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms

Schröder,

Mallmann,

Domroese

et al. 2023

Diagnostics

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“…Joint use can improve specificity and sensitivity in clinical application. Among them, NSE and ProGRP are ideal indicators for diagnosing SCLC ( Li et al, 2022 ), CEA, CYFRA21-1, and SCC are helpful for the auxiliary diagnosis of NSCLC ( Mishra et al, 2021 ), and CYFRA21-1 and SCC are considered to be specific for squamous cell carcinoma ( Fatica et al, 2022 ). Another six biomarkers, namely, carcinoma antigen 125 (CA125) ( Yang et al, 2018 ), epidermal growth factor receptor (EGFR) ( Scharpenseel et al, 2019 ), isocitrate dehydrogenase 1 (IDH1) ( Mishra et al, 2021 ), thyroid transcription factor-1 (TTF-1) ( Liu et al, 2018 ), synaptophysin (SYN) ( Wang et al, 2020 ), and neural cell adhesion molecule (CD56) ( Svajdler et al, 2019 ) were selected according to their frequency of being mentioned in the relevant literature.…”

Section: Methodsmentioning

confidence: 99%

Miniaturized microfluidic-based nucleic acid analyzer to identify new biomarkers of biopsy lung cancer samples for subtyping

Xue

Bo²,

Lv³

et al. 2022

Front. Chem.

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Identifying new biomarkers is necessary and important to diagnose and treat malignant lung cancer. However, existing protein marker detection methods usually require complex operation steps, leading to a lag time for diagnosis. Herein, we developed a rapid, minimally invasive, and convenient nucleic acid biomarker recognition method, which enabled the combined specific detection of 11 lung cancer typing markers in a microliter reaction system after only one sampling. The primers for the combined specific detection of 11 lung cancer typing markers were designed and screened, and the microfluidic chip for parallel detection of the multiple markers was designed and developed. Furthermore, a miniaturized microfluidic-based analyzer was also constructed. By developing a microfluidic chip and a miniaturized nucleic acid analyzer, we enabled the detection of the mRNA expression levels of multiple biomarkers in rice-sized tissue samples. The miniaturized nucleic acid analyzer could detect ≥10 copies of nucleic acids. The cell volume of the typing reaction on the microfluidic chip was only 0.94 μL, less than 1/25 of that of the conventional 25-μL Eppendorf tube PCR method, which significantly reduced the testing cost and significantly simplified the analysis of multiple biomarkers in parallel. With a simple injection operation and reverse transcription loop-mediated isothermal amplification (RT-LAMP), real-time detection of 11 lung cancer nucleic acid biomarkers was performed within 45 min. Given these compelling features, 86 clinical samples were tested using the miniaturized nucleic acid analyzer and classified according to the cutoff values of the 11 biomarkers. Furthermore, multi-biomarker analysis was conducted by a machine learning model to classify different subtypes of lung cancer, with an average area under the curve (AUC) of 0.934. This method shows great potential for the identification of new nucleic acid biomarkers and the accurate diagnosis of lung cancer.

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“…Their expression has been detected mainly at the tumor level and to a markedly lesser extent as circulating molecules. SCC-A is the most studied biomarker and is overexpressed in distinct squamous cell cancers, including the following: Esophagus, lung, head, neck, and in anal canal, and uterine cervix, as well as in vulvar and penile carcinoma (101)(102)(103)(104)(105). Meanwhile, YKL-40 has demonstrated high tissue levels in anal carcinoma and it has been detected in the plasma of patients with esophageal cancer (106) and CA-125 showed relatively high circulating levels in vulvar carcinoma (107).…”

Section: Expression Of Circulating Biomarkers In Other Hpvrelated Can...mentioning

confidence: 99%

Circulating cervical cancer biomarkers potentially useful in medical attention (Review)

Garrido

Gutiérrez²,

Flores

2023

Mol Clin Oncol

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Cervical cancer (CC) is a public health problem worldwide, including Mexico. This type of cancer is the fourth most frequent in women worldwide; in Mexico it is the second most common type in women after breast cancer. The diagnosis of CC is based mainly on Pap smears and colposcopy and the identification of molecular tools that serve as a support for these methods is urgent. Regarding this, differential expressions of specific circulating biomolecules has been detected and, based on this, they have been postulated as potential biomarkers for CC diagnosis, prognosis, and/or to identify the response to treatments. Importantly, the combined analysis of these molecules considerably improves their efficacy as biomarkers and their potential use in the medical attention is promising. Contents1. Introduction 2. Proteins 3. ncRNAs 4. The estrogen effect on the expression of biomarkers 5. cDNA 6. Putative molecular mechanisms altered by the CC biomarkers 7. Circulating biomarkers expression in other HPV-related cancers 8. How feasible is it to use a test of this type in the heath sector of undeveloped countries? 9. The best biomarkers panel, according to our point of view 10. Conclusions and future directions

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Performance characteristics of the BRAHMS KRYPTOR automated squamous cell carcinoma antigen assay

Cited by 3 publications

References 31 publications

Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms

Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms

Miniaturized microfluidic-based nucleic acid analyzer to identify new biomarkers of biopsy lung cancer samples for subtyping

Circulating cervical cancer biomarkers potentially useful in medical attention (Review)

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