scholarly journals Target Enrichment Enhances the Sensitivity of Sanger Sequencing for BRAF V600 Mutation Detection

2021 ◽  
Author(s):  
Qiang Qan ◽  
Andrew Fu ◽  
Fang Liu ◽  
Shuo Shen ◽  
Maidar Jamba ◽  
...  
Keyword(s):  
Braf Mutation ◽  
Sanger Sequencing ◽  
Cancer Diagnostics ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
Target Enrichment ◽  
Mutation Status ◽  
Highly Sensitive ◽  
Braf V600 Mutation ◽  
Limited Sensitivity

BRAF is a serine/threonine protein kinase whose mutations lead to unregulated cell growth and cause different types of cancers. Since V600E is a major BRAF mutation and V600E detection as a companion diagnostic test (CDx) is stipulated in the labeling of the BRAF V600 inhibitors. Traditional Sanger sequencing cannot accurately detect mutations lower than 15% variant allele frequency (VAF) due to its limited sensitivity. Here we applied our patented XNA molecular clamping technology to modify Sanger sequencing template preparation by enriching the mutation population. We found that the use of our mutation-enriched template enhanced the analytical sensitivity of Sanger sequencing to 0.04% VAF. The method is verified to detect V600E, V600K, and V600R mutants and is validated for the known BRAF mutation status in clinical samples. Our streamlined protocol can be used for easy validation of the highly sensitive target-enrichment method for detecting BRAF V600 mutations using Sanger sequencing in clinical labs. In addition to BRAF V600 mutations, this method can be extended to the detection of other clinically important actionable mutations for cancer diagnostics.

The impact of BRAF mutation status on clinical outcomes with single-agent PD-1 inhibitor versus combination ipilimumab/nivolumab.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10024-10024
Author(s):  
Vincent The-Luc Ma ◽  
Stephanie Daignault ◽  
Jessica Waninger ◽  
Leslie Anne Fecher ◽  
Michael Green ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Retrospective Analysis ◽  
Braf Mutation ◽  
Univariate Analysis ◽  
Single Agent ◽  
Mutation Status ◽  
Melanoma Patients ◽  
The Impact ◽  
Braf Mutant ◽  
Braf V600 Mutation

10024 Background: Nearly half of all metastatic melanoma patients possess the BRAF V600 mutation. Several therapies are approved for BRAF mutant metastatic melanoma, but it is unclear if there is a differential outcome to various immunotherapy regimens. Our aim was to better assess if BRAF mutation status has any impact on survival to combination ipilimumab/nivolumab (I/N) versus single-agent PD-1 inhibitor (PD-1i). Methods: We performed a single center, retrospective analysis on a cohort of patients diagnosed with metastatic or unresectable melanoma from 2012 to 2019 at the University of Michigan who were treated with standard I/N or PD-1i (nivolumab or pembrolizumab). A univariate analysis of progression free survival (PFS) and overall survival (OS) was stratified by treatment type and BRAF mutation status. A multivariate Cox regression of survival was used to compare the effects of the treatment groups adjusted by BRAF status, age, gender, pre-treatment LDH level, prior treatment status, and brain metastases status. Results: 323 patients were identified. 132 had BRAF V600 mutation and 191 had BRAF wildtype (WT) status. 138 patients received I/N and 185 patients received PD-1i. In our univariate analysis, there was no difference in PFS [HR: 0.72, 95% CI, 0.46 – 1.13] or OS [HR: 0.78, 0.44 – 1.38] with I/N versus PD-1i in the BRAF mutant cohort, but there was improved PFS [HR: 0.55, 0.35 – 0.88) and OS [HR: 0.52, 0.28 – 0.95] with I/N compared to PD-1i in the BRAF WT group. In the multivariate analysis, the BRAF WT group continued to show PFS benefit with I/N compared to PD-1i [HR: 0.57, 95% CI, 0.35 – 0.95], but the OS benefit no longer achieved statistical significance [HR: 0.54, 0.28 – 1.03]. Conclusions: Our study results were discordant with the observation in the landmark CheckMate 067 trial, which noted improved PFS and OS with I/N compared to nivolumab alone in the BRAF mutant group and no difference in the BRAF WT group. In our real-world retrospective analysis, I/N over PD-1i should be considered as initial immunotherapy for metastatic melanoma patients regardless of BRAF mutation status, but even more favorably in BRAF WT.

scholarly journals Comparative evaluation of published cytomegalovirus primers for rapid real-time PCR: which are the most sensitive?

2009 ◽  
Vol 58 (7) ◽  
pp. 878-883 ◽  
Author(s):  
Wafa Habbal ◽  
Fawza Monem ◽  
Barbara C. Gärtner
Keyword(s):  
Real Time ◽  
Real Time Pcr ◽  
Clinical Isolates ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
Pcr Product ◽  
Highly Sensitive ◽  
Primer Sets ◽  
Analytical Sensitivities ◽  
Strain Ad169

Standardization of human cytomegalovirus (CMV) PCR is highly recommended. As primer design is essential for PCR sensitivity, this study evaluated all published CMV primer pairs to identify the most sensitive for single-round real-time PCR. PubMed (1993–2004) was searched for original papers aimed at CMV PCR. Fifty-seven papers were identified revealing 82 different primer pairs. Of these, 17 primer sets were selected for empirical study, as they were either used in real-time PCR or were evaluated comparatively by conventional PCR. After optimizing the PCR conditions, these primer sets were evaluated by real-time PCR using a SYBR Green format. Analytical sensitivities were assessed by testing the reference standard CMV strain AD169. A blast search was performed to identify mismatches with published sequences. Additionally, 60 clinical samples were tested with the three primer sets showing highest analytical sensitivity and the best match to all CMV strains. Three primer sets located in the glycoprotein B (UL55) gene region were found to be the most sensitive using strain AD169. However, two of these showed a considerable number of mismatches with clinical isolates in a blast search. Instead, two other pairs from the lower matrix phosphoprotein (UL83) gene and DNA polymerase (UL54) gene showed reasonable sensitivity and no mismatches with clinical isolates. These three pairs were further tested with clinical samples, which indicated that the two primer sets from UL55 and UL54 were the most sensitive. Interestingly, the analytical sensitivity of the PCR was inversely correlated with the size of the PCR product. In conclusion, these two primer pairs are recommended for a standardized, highly sensitive, real-time PCR.

scholarly journals A Novel Xenonucleic Acid Mediated Molecular Clamping Technology for Early Colorectal Cancer Screening

2020 ◽  
Author(s):  
Qing Sun ◽  
Larry Pastor ◽  
Jinwei Du ◽  
Michael J. Powell ◽  
Aiguo Zhang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Precancerous Lesions ◽  
Cancer Diagnostics ◽  
Clinical Samples ◽  
Early Colorectal Cancer ◽  
Analytical Sensitivity ◽  
Assay Sensitivity ◽  
Specificity And Sensitivity ◽  
Ffpe Samples ◽  
Total Dna

Abstract BackgroundColorectal cancer (CRC) is one of the leading causes of cancer-related death. Early detection is critical to reduce CRC morbidity and mortality. In order to meet this need, we developed a molecular clamping assay called the ColoScape TM for early colorectal cancer diagnostics. MethodsNineteen mutations in four genes APC, KRAS, BRAF and CTNNB1 associated with early events in CRC pathogenesis are targeted in the ColoScapeTM assay. Xenonucleic Acid (XNA) mediated qPCR clamping technology was applied to minimize the wild-type background amplification in order to improve assay sensitivity of CRC mutation detection. The assay analytical performance was verified and validated, cfDNA and FFPE CRC patient samples were evaluated, and a ROC cure was applied to evaluate its performance.ResultsThe data showed that the assay analytical sensitivity is 0.5% Variant Allele Frequency, corresponding to ~7-8 copies of mutant DNA with 5ng total DNA input per test. This assay is highly reproducible with intra-assay CV <3% and inter-assay <5%. We have investigated 380 clinical samples including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC. The preliminary assay clinical specificity and sensitivity for CRC cfDNA were 100% (95% CI, 80.3-97.5%) and 92.2% (95% CI, 94.7-100%) respectively with AUC being about 0.96; and 96% (95% CI, 77.6-99.7%) specificity and 92% (95% CI, 86.1-95.6%) sensitivity with AUC 0.94 for CRC FFPE; and 95% specificity (95% CI, 82.5%-99.1%) and 62.5% sensitivity (95% CI, 35.8%-83.7%) with AUC 0.79 for precancerous lesions cfDNA.ConclusionsXNA mediated molecular clamping assay is a rapid, precise, and sensitive assay for the detection of precancerous lesions cfDNA and CRC cfDNA or FFPE samples.

scholarly journals Development of a highly sensitive magneto-enzyme lateral flow immunoassay for dengue NS1 detection

PeerJ ◽  
2019 ◽  
Vol 7 ◽  
pp. e7779 ◽  
Author(s):  
Tien V. Tran ◽  
Ba V. Nguyen ◽  
Thao T.P. Nguyen ◽  
Tung T. Tran ◽  
Khanh G. Pham ◽  
...  
Keyword(s):  
Test Performance ◽  
Limit Of Detection ◽  
Dengue Infection ◽  
Cross Reactivity ◽  
Lateral Flow ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
The Novel ◽  
Structural Protein ◽  
Highly Sensitive

Background Dengue infection represents a global health issue of growing importance. Dengue non-structural protein 1 (NS1) plays a central role in the early detection of the disease. The most common method for NS1 detection is testing by lateral flow immunoassays (LFIAs) with varying sensitivity. In this study, we present a highly sensitive magneto-enzyme LFIA for prompt diagnosis of dengue. Methods We have demonstrated the development of a magneto-enzyme LFIA combining super-paramagnetic nanoparticles as labels and Biotin–Streptavidin signal amplification strategy to detect dengue NS1. Factors affecting the test performance including antibody pair, super-paramagnetic nanoparticle size, nitrocellulose membrane type, amounts of detection and capture antibodies, and amounts of Streptavidin-polyHRP were optimized. Analytical sensitivity and cross-reactivity were determined. Clinical performance of the novel assay was evaluated using a panel of 120 clinical sera. Results This newly developed assay could detect NS1 of all four serotypes of dengue virus (DENV). The limit of detection (LOD) was found to be as low as 0.25 ng ml−1 for DENV-1 and DENV-3, 0.1 ng ml−1 for DENV-2, and 1.0 ng ml−1 for DENV-4. The LOD for DENV-2 was a 50-fold improvement over the best values previously reported. There was an absence of cross-reactivity with Zika NS1, Hepatitis B virus, Hepatitis C virus, and Japanese encephalitis virus. The sensitivity and specificity of the novel assay were 100% when tested on clinical samples. Conclusions We have successfully developed a magneto-enzyme LFIA, allowing rapid and highly sensitive detection of dengue NS1, which is essential for proper management of patients infected with DENV.

scholarly journals A novel xenonucleic acid-mediated molecular clamping technology for early colorectal cancer screening

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0244332
Author(s):  
Qing Sun ◽  
Larry Pastor ◽  
Jinwei Du ◽  
Michael J. Powell ◽  
Aiguo Zhang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Precancerous Lesions ◽  
Cancer Diagnostics ◽  
Clinical Samples ◽  
Early Colorectal Cancer ◽  
Analytical Sensitivity ◽  
Assay Sensitivity ◽  
Specificity And Sensitivity ◽  
Ffpe Samples ◽  
Total Dna

Background Colorectal cancer (CRC) is one of the leading causes of cancer-related death. Early detection is critical to reduce CRC morbidity and mortality. In order to meet this need, we developed a molecular clamping assay called the ColoScape TM assay for early colorectal cancer diagnostics. Methods Nineteen mutations in four genes (APC, KRAS, BRAF and CTNNB1) associated with early events in CRC pathogenesis are targeted in the ColoScapeTM assay. Xenonucleic Acid (XNA)-mediated qPCR clamping technology was applied to minimize the wild-type background amplification in order to improve assay sensitivity of CRC mutation detection. The assay analytical performance was verified and validated, cfDNA and FFPE CRC patient samples were evaluated, and an ROC curve was applied to evaluate its performance. Results The data showed that the assay analytical sensitivity was 0.5% Variant Allele Frequency, corresponding to ~7–8 copies of mutant DNA with 5 ng total DNA input per test. This assay is highly reproducible with intra-assay CV of <3% and inter-assay CV of <5%. We have investigated 380 clinical samples including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC. The preliminary assay clinical specificity and sensitivity for CRC cfDNA were: 100% (95% CI, 80.3–97.5%) and 92.2% (95% CI, 94.7–100%), respectively, with AUC of 0.96; 96% specificity (95% CI, 77.6–99.7%) and 92% sensitivity (95% CI, 86.1–95.6%) with AUC of 0.94 for CRC FFPE; 95% specificity (95% CI, 82.5%–99.1%) and 62.5% sensitivity (95% CI, 35.8%–83.7%) with AUC of 0.79 for precancerous lesions cfDNA. Conclusions The XNA-mediated molecular clamping assay is a rapid, precise, and sensitive assay for the detection of precancerous lesions cfDNA and CRC cfDNA or FFPE samples.

scholarly journals ARMS-PCR for detection of BRAF V600E hotspot mutation in comparison with Real-Time PCR-based techniques.

2013 ◽  
Vol 60 (1) ◽  
Author(s):  
Marcin M Machnicki ◽  
Eliza Glodkowska-Mrowka ◽  
Tomasz Lewandowski ◽  
Rafał Ploski ◽  
Pawel Wlodarski ◽  
...  
Keyword(s):  
Braf Mutation ◽  
Mutant Allele ◽  
Sanger Sequencing ◽  
Braf V600e ◽  
Amplification Refractory Mutation System ◽  
Lower Sensitivity ◽  
Tissue Samples ◽  
Mutation Status ◽  
Arms Pcr ◽  
Hotspot Mutation

BRAF mutation testing is one of the best examples how modern genetic testing may help to effectively use targeted therapies in cancer patients. Since many different genetic techniques are employed to assess BRAF mutation status with no available comparison of their sensitivity and usefulness for different types of samples, we decided to evaluate our own PCR-based assay employing the amplification refractory mutation system (ARMS-PCR) to detect the most common hotspot mutation c. T1799A (p. V600E) by comparing it with two qPCR based assays: a commercially available test with hybridizing probes (TIB MOLBIOL) and high resolution melting (HRM). Positive results were verified with Sanger sequencing. DNA from two cancer cell lines with known mutation status and from tissue samples from melanoma and gastric cancer was used. ARMS-PCR was the most sensitive method with the level of detection of the mutant allele at 2%. Similar sensitivity was observed for the qPCR-based commercial test employing hybridizing probes; however, this test cannot exclude negative results from poor or low quality samples. Another qPCR-based method, HRM, had lower sensitivity with the detection level of approximately 20%. An additional drawback of HRM methodology was the inability to distinguish between wild type and mutant homozygotes in a straightforward assay, probably due to the character of this particular mutation (T\>A). Sanger sequencing had the sensitivity of the detection of mutant allele similar to HRM, approx. 20%. In conclusion, simple ARMS-PCR may be considered the method of choice for rapid, cost-effective screening for BRAF p. V600E mutation.

scholarly journals Clinical Implication of Highly Sensitive Detection of the BRAF V600E Mutation in Fine-Needle Aspirations of Thyroid Nodules: A Comparative Analysis of Three Molecular Assays in 4585 Consecutive Cases in a BRAF V600E Mutation-Prevalent Area

2012 ◽  
Vol 97 (7) ◽  
pp. 2299-2306 ◽  
Author(s):  
Seung-Tae Lee ◽  
Sun Wook Kim ◽  
Chang-Seok Ki ◽  
Ja-Hyun Jang ◽  
Jung Hee Shin ◽  
...  
Keyword(s):  
Sanger Sequencing ◽  
Thyroid Nodules ◽  
Braf V600e Mutation ◽  
Braf V600e ◽  
Detection Sensitivity ◽  
Mutation Status ◽  
Fine Needle ◽  
Molecular Assays ◽  
Dual Priming Oligonucleotide ◽  
Highly Sensitive

Abstract Context: Detection of the BRAF V600E mutation in fine-needle aspiration cytology (FNAC) specimens may increase the value of FNAC. Objective: The objectives of the study was to compare the diagnostic performance of BRAF assays that differ in sensitivity and to examine the associations between the BRAF V600E mutation status and the clinicopathological features in papillary thyroid carcinoma (PTC). Design and Setting: Three molecular assays were performed in all subjects and compared with regard to FNAC and histology results. Participants: We evaluated 4585 consecutive patients who were found to have malignant or indeterminate thyroid nodules by ultrasonography. Outcome Measures: All FNAC samples were tested for the BRAF V600E mutation using conventional Sanger sequencing, dual-priming oligonucleotide-PCR, and mutant enrichment with 3′-modified oligonucleotide (MEMO) sequencing. Results: The detection sensitivities of the three molecular assays for the BRAF V600E mutation were 20, 2, and 0.1%, respectively. Compared with conventional Sanger sequencing (n = 673), dual-priming oligonucleotide-PCR and MEMO sequencing detected more tumors with the BRAF V600E mutation (n = 919 and n = 1044, respectively), especially tumors with a benign, indeterminate, or nondiagnostic cytology. All BRAF-positive tumors that were histologically examined were shown to be PTC, regardless of cytology results. The clinical sensitivities of the three assays for detecting PTC were 54.8, 74.4, and 79.7%, respectively. BRAF V600E mutations in microcarcinomas (≤10 mm) were detected more efficiently as the detection sensitivity of the assay increased (P &lt; 0.001). Tumor size correlated significantly with multifocality, extrathyroidal extension, and lymph node metastasis (P = 0.003, P &lt; 0.001 and P &lt; 0.001, respectively), but the BRAF V600E mutation status was not associated with any of those features. Conclusion: Highly sensitive and specific molecular assays such as MEMO sequencing are optimal for detecting the BRAF mutations in thyroid FNAC because these techniques can detect PTC that might be missed by cytology or less sensitive molecular assays.

scholarly journals A Novel Xenonucleic Acid Mediated Molecular Clamping Technology for Early Colorectal Cancer Screening

2020 ◽  
Author(s):  
Qing Sun ◽  
Larry Pastor ◽  
Jinwei Du ◽  
Michael J. Powell ◽  
Aiguo Zhang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Precancerous Lesions ◽  
Cancer Diagnostics ◽  
Clinical Samples ◽  
Early Colorectal Cancer ◽  
Analytical Sensitivity ◽  
Assay Sensitivity ◽  
Specificity And Sensitivity ◽  
Ffpe Samples ◽  
Total Dna

ABSTRACTBackgroundColorectal cancer (CRC) is one of the leading causes of cancer-related death. Early detection is critical to reduce CRC morbidity and mortality. In order to meet this need, we developed a molecular clamping assay called the ColoScape ™ for early colorectal cancer diagnostics.MethodsNineteen mutations in four genes APC, KRAS, BRAF and CTNNB1 associated with early events in CRC pathogenesis are targeted in the ColoScape™ assay. Xenonucleic Acid (XNA) mediated qPCR clamping technology was applied to minimize the wild-type background amplification in order to improve assay sensitivity of CRC mutation detection. The assay analytical performance was verified and validated, cfDNA and FFPE CRC patient samples were evaluated, and a ROC cure was applied to evaluate its performance.ResultsThe data showed that the assay analytical sensitivity is 0.5% Variant Allele Frequency, corresponding to ~7-8 copies of mutant DNA with 5ng total DNA input per test. This assay is highly reproducible with intra-assay CV <3% and inter-assay <5%. We have investigated 380 clinical samples including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC. The preliminary assay clinical specificity and sensitivity for CRC cfDNA were 100% (95% CI, 80.3-97.5%) and 92.2% (95% CI, 94.7-100%) respectively with AUC being about 0.96; and 96% (95% CI, 77.6-99.7%) specificity and 92% (95% CI, 86.1-95.6%) sensitivity with AUC 0.94 for CRC FFPE; and 95% specificity (95% CI, 82.5%-99.1%) and 62.5% sensitivity (95% CI, 35.8%-83.7%) with AUC 0.79 for precancerous lesions cfDNA.ConclusionsXNA mediated molecular clamping assay is a rapid, precise, and sensitive assay for the detection of precancerous lesions cfDNA and CRC cfDNA or FFPE samples.

A novel xenonucleic acid mediated molecular clamping technology for early colorectal cancer diagnostics.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16106-e16106
Author(s):  
Qing Sun ◽  
Larry Pastor ◽  
Jinwei Du ◽  
Michael Joseph Powell ◽  
Aiguo Zhang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Performance ◽  
Cancer Diagnostics ◽  
Clinical Samples ◽  
Early Colorectal Cancer ◽  
Analytical Sensitivity ◽  
Assay Sensitivity ◽  
Specificity And Sensitivity ◽  
Ffpe Samples ◽  
Performance Results

e16106 Background: Colorectal cancer (CRC) is one of the leading causes of cancer-related death. Early detection is critical to reduce CRC morbidity and mortality. In order to meet this need, we developed a molecular clamping assay called ColoScape for early colorectal cancer diagnostics. Methods: Nineteen mutations in four genes APC, KRAS, BRAF and CTNNB1 associated with early events in CRC pathogenesis are targeted in the ColoScape assay. Xenonucleic Acid (XNA) mediated qPCR clamping technology was applied to minimize the wild-type background amplification in order to improve assay sensitivity of CRC mutation detection. The assay analytical performance was verified and validated, cfDNA and FFPE CRC patient samples were assessed for clinical performance, and a ROC curve was applied to evaluate its performance. Results: The data showed that the assay analytical sensitivity is 0.5% Variant Allele Frequency, corresponding to ~7-8 copies of mutant DNA with 5ng total DNA input per test. This assay is highly reproducible with intra-assay CV < 3% and inter-assay CV < 5%. We have investigated 380 clinical samples including plasma cfDNA and FFPE samples from patients with different stages of CRC. The preliminary assay clinical specificity and sensitivity for cfDNA were 100% (95% CI, 80.3-97.5%) and 92.2% (95% CI, 94.7-100%) respectively with AUC being about 0.96; and 96% (95% CI, 77.6-99.7%) specificity and 92% (95% CI, 86.1-95.6%) sensitivity with AUC 0.94 for FFPE. Conclusions: XNA mediated molecular clamping assay is a rapid, precise, and sensitive assay for the detection of CRC mutations in cfDNA or FFPE samples.

scholarly journals Highly Sensitive Chemiluminescence-Based Lateral Flow Immunoassay for Cardiac Troponin I Detection in Human Serum

Sensors ◽  
2020 ◽  
Vol 20 (9) ◽  
pp. 2593 ◽  
Author(s):  
Gyeo-Re Han ◽  
Min-Gon Kim
Keyword(s):  
Cardiac Troponin ◽  
High Performance ◽  
Troponin I ◽  
Performance Testing ◽  
Lateral Flow ◽  
Cardiac Troponin I ◽  
World Health ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
Highly Sensitive

Lateral flow assays (LFAs) have become the most common biosensing platforms for point-of-care testing due to their compliance with the ASSURED (affordable, sensitive, specific, user-friendly, rapid/robust, equipment-free, and deliverable to end-users) guidelines stipulated by the World Health Organization. However, the limited analytical sensitivity and low quantitative capability of conventional LFAs, which use gold nanoparticles (AuNPs) for colorimetric labeling, have prevented high-performance testing. Here, we report the development of a highly sensitive chemiluminescence (CL)-based LFA involving AuNPs conjugated with aldehyde-activated peroxidase and antibody molecules—i.e., AuNP-(ald)HRP-Ab—as a new conjugation scheme for high-performance testing in LFAs. When paired with the CL-based signal readout modality, the AuNP-(ald)HRP-Ab conjugate resulted in 110-fold enhanced sensitivity over the colorimetric response of a typical AuNP-Ab conjugate. To evaluate the performance of the CL-based LFA, we tested it with human cardiac troponin I (cTnI; a standard cardiac biomarker used to diagnose myocardial infarction) in standard and clinical serum samples. Testing the standard samples revealed a detection limit of 5.6 pg·mL−1 and acceptably reliable precision (with a coefficient of variation of 2.3%–8.4%), according to clinical guidelines. Moreover, testing the clinical samples revealed a high correlation (r = 0.97) with standard biochemical analyzers, demonstrating the potential clinical utility of the CL-based LFA for high-performance cTnI testing.

Sign in / Sign up

Export Citation Format

Share Document