scholarly journals Real-time tablet-based resuscitation documentation by the team leader: evaluating documentation quality and clinical performance

2016 ◽  
Vol 24 (1) ◽  
Author(s):  
T. Grundgeiger ◽  
M. Albert ◽  
D. Reinhardt ◽  
O. Happel ◽  
A. Steinisch ◽  
...  
Keyword(s):  
Real Time ◽  
Clinical Performance ◽  
Team Leader ◽  
Documentation Quality

scholarly journals A fast and efficient model for real-time anti-tumor drug efficacy test in the clinical setting based on patient-derived tumor xenograft

2021 ◽  
Author(s):  
Yanping Zhu ◽  
Hui Zheng ◽  
Qian Wang ◽  
Zhiqiang Wang ◽  
Hang Song ◽  
...  
Keyword(s):  
Real Time ◽  
Clinical Setting ◽  
Comprehensive Evaluation ◽  
Malignant Tumors ◽  
Clinical Performance ◽  
Tumor Biology ◽  
Drug Efficacy ◽  
Tumor Xenograft ◽  
Therapeutic Window ◽  
Genetic Characteristics

Abstract Drug response rates in cancer therapies are frequently unsatisfactory (first-line 30-40%, subsequent-line ~10% or less). The mouse model, patient-derived tumor xenograft (PDTX), can help promote drug effective rate to over 80% by precisely electing efficacious agents. However, the low engraftment rates, extended testing cycle, and high cost limit its utilization in the clinical setting. A novel method, FastPDTX, was developed, in which a substitutive engrafting procedure was applied, and the labor-intensive and time-consuming propagation of tumorgrafts was circumvented by pathological analysis. A comprehensive evaluation involving tumor biology and clinical performance was performed for this new model. The clinical evaluation engaged 431 PDTX cases, 1050 FastPDTX cases, 531 therapeutic entities, 6535 regimens, and a broad spectrum of solid tumors. Typical cases were also studied, covering various refractory malignant tumors. FastPDTX kept biological architectures and genetic characteristics of the primary tumor and displayed an equivalent positive predictive value as PDTX for the drug efficacy test. The testing cycle was reduced from 3-6 months to 3 weeks, and the cost was decreased by 85%. More importantly, the obstacle of low engraftment rate was circumvented, resulting in the percentage of appliable tests nearly 5-fold higher (94.8% vs. 16.7%) than PDTX. FastPDTX is particularly suitable in circumstances where standard care is not available and the therapeutic window is short, and for cases where tumors have indolent growth in mice. FastPDTX preserved the advantages of classical PDTX, overcame its major limitations, and showed great potential for real-time clinic drug selection in cancer therapy.

scholarly journals Triplex Real Time RT-PCR for N1, N2 and RP probes from CDC EUA SARS-CoV-2 diagnosis kit

2020 ◽  
Author(s):  
Byron Freire-Paspuel ◽  
Patricio Vega-Mariño ◽  
Alberto Velez ◽  
Marilyn Cruz ◽  
Miguel Angel Garcia-Bereguiain
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Real Time ◽  
Reverse Transcription ◽  
Clinical Performance ◽  
Rt Pcr ◽  
Reverse Transcription Pcr ◽  
Speed Up

AbstractCDC protocol for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) include 3 targets for detection (N1, N2 and RP) labelled with FAM so 3 PCR reactions are required per sample. We developed a triplex, real-time reverse transcription PCR for SARS-CoV-2 that maintained clinical performance compared with CDC singleplex assay. This protocol could speed up detection and save reagents during current SARS-CoV-2 testing supplies shortage.

Development of Endoscopic Surgery Navigated by Artificial Intelligence

2021 ◽  
Vol 39 ◽  
Author(s):  
Masafumi Inomata ◽  
◽  
Atsuro Fujinaga ◽  
Hiroaki Nakanuma ◽  
Yuichi Endo ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Laparoscopic Cholecystectomy ◽  
Bile Duct ◽  
Real Time ◽  
Endoscopic Surgery ◽  
Performance Test ◽  
Clinical Performance ◽  
Lower Surface ◽  
Organ Damage ◽  
Anatomical Landmarks

Endoscopic surgery, which was first introduced in the late 1980s, has rapidly become widespread. However, despite its popularity, the occurrence of intraoperative organ damage has not necessarily decreased. To avoid intraoperative bile duct injury in laparoscopic cholecystectomy, which is one of the most popular procedures in endoscopic surgery, we are developing a laparoscopic surgical system that uses Artificial Intelligence (AI) to identify four anatomical landmarks (cystic duct of the gallbladder, common bile duct, lower surface of hepatic S4, and Rouviere’s sulcus, related to “Calot’s triangle") in real time during surgery. The development process consists of 5 steps: 1) identification of anatomical landmarks, 2) collection and creation of teaching data, 3) annotation and deep learning, 4) validation of development model, and 5) actual clinical performance evaluation. At present, anatomical landmarks can be identified with high accuracy in an actual clinical performance test in laparoscopic cholecystectomy, whereas issues for practical clinical use, such as a need to recognize the scene of surgical steps and surgical difficulties related to inflammation of the gallbladder, have also been clarified. The development of an AI-navigation system for endoscopic surgery, which could identify anatomical landmarks in real time during surgery, could be expected to support surgeons' decisions, reduce surgical complications, and contribute to improving the quality of surgical treatments.

scholarly journals Validation of a Real-Time PCR–Based Qualitative Assay for the Detection of Methylated SEPT9 DNA in Human Plasma

2014 ◽  
Vol 60 (9) ◽  
pp. 1183-1191 ◽  
Author(s):  
Nicholas T Potter ◽  
Patrick Hurban ◽  
Mary N White ◽  
Kara D Whitlock ◽  
Catherine E Lofton-Day ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Real Time ◽  
Real Time Pcr ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Methylation Status ◽  
Screening Guidelines ◽  
Crc Screening ◽  
Clinical Trial Results ◽  
A Prospective Study

Abstract BACKGROUND Epi proColon® is a new blood-based colorectal cancer (CRC) screening test designed to determine the methylation status of a promoter region of the SEPT9 (septin 9) gene in cell-free DNA isolated from plasma. We describe the analytical and clinical performance of the test. METHODS Analytical performance at 4 testing laboratories included determination of limit of detection, precision, and reproducibility of the SEPT9 test. Clinical performance was evaluated in a prospective study by use of samples (n = 1544) from subjects enrolled in the PRESEPT clinical trial. Results were analyzed by comparison with colonoscopy, the reference standard. RESULTS The limit of detection for methylated SEPT9 DNA was 7.8 pg/mL (95% CI 6–11 pg/mL) corresponding to <2 genome copies of methylated SEPT9 per milliliter of plasma. In the prospective clinical trial, sensitivity for all stages of CRC was 68% (95% CI 53%–80%) and for stage I–III CRC, 64% (48%–77%). Adjusted specificity, on the basis of negative colonoscopy findings, was 80.0% (78%–82%). SIGNIFICANCE: The Epi proColon test is a simple, real-time PCR–based assay for the detection of methylated SEPT9 DNA in blood that may provide a noninvasive CRC screening alternative for people noncompliant with current CRC screening guidelines.

SLCO1B1 c.521T>C Genotyping in the Austrian Population Using 2 Commercial Real-Time Polymerase Chain Reaction Assays: An Implementation Study

Pharmacology ◽  
2018 ◽  
Vol 102 (1-2) ◽  
pp. 88-90
Author(s):  
Dietmar Enko ◽  
Sophia Harringer ◽  
Christian Oberkanins ◽  
Helene Pühringer ◽  
Gabriele Halwachs-Baumann ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Real Time Pcr ◽  
Clinical Performance ◽  
Chain Reaction ◽  
Increased Risk ◽  
Polymerase Chain ◽  
Pcr Assays ◽  
Austrian Population ◽  
Genotype And Allele Frequencies

Statin-induced myopathy is reported to be significantly associated with the SCLO1B1 c.521T>C polymorphism. To date, SLCO1B1 c.521T>C epidemiologic data for the Austrian population is still lacking. Therefore, this study aimed at assessing the genotype and allele frequencies of the SLCO1B1 c.521T>C variant in Austria and evaluating the clinical performance of 2 commercial real-time polymerase chain reaction (PCR) assays. Genomic DNA isolated from 181 healthy individuals was analyzed for the SLCO1B1 c.521T>C polymorphism in a comparative manner using the SLCO1B1 c.521T>C RealFastTM Assay and the BioPro SLCO1B1 Genotyping real-time PCR Kit. A total of 10 (5.5%) and 44 (24.3%) out of 181 individuals were SLCO1B1 c.521T>C C/C-homo- and ­C/T-heterozygotes, the genotypes indicative of high and increased risk of statin-induced myopathy, respectively. The SLCO1B1 c.521C allele frequency rate was 17.7%. In conclusion, the genetic predisposition of elevated statin-induced myopathy risk in the Austrian population is frequent. Both real-time PCR assays under investigation here are reliable and robust SLCO1B1 c.521T>C genotyping tools in clinical routine.

scholarly journals Clinical Evaluation of the Novel Rapid Nucleic Acid Amplification Point-of-Care Test (Smart Gene SARS-CoV-2) in the analysis of Nasopharyngeal and Anterior Nasal samples.

2021 ◽  
Author(s):  
Yoshihiko Kiyasu ◽  
Masato Owaku ◽  
Yusaku Akashi ◽  
Yuto Takeuchi ◽  
Kenji Narahara ◽  
...  
Keyword(s):  
Real Time ◽  
Clinical Performance ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Molecular Testing ◽  
The Novel ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Point Of Care Test ◽  
Hands On

Introduction Smart Gene is a point-of-care (POC)-type automated molecular testing platform that can be performed with 1 minute of hands-on-time. Smart Gene SARS-CoV-2 is a newly developed Smart Gene molecular assay for the detection of SARS-CoV-2. The analytical and clinical performance of Smart Gene SARS-CoV-2 has not been evaluated. Methods Nasopharyngeal and anterior nasal samples were prospectively collected from subjects referred to the local PCR center from March 25 to July 5, 2021. Two swabs were simultaneously obtained for the Smart Gene SARS-CoV-2 assay and the reference real-time RT-PCR assay, and the results of Smart Gene SARS-CoV-2 were compared to the reference real-time RT-PCR assay. Results Among a total of 1150 samples, 68 of 791 nasopharyngeal samples and 51 of 359 anterior nasal samples were positive for SARS-CoV-2 in the reference real-time RT-PCR assay. In the testing of nasopharyngeal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 99.2% (95% confidence interval [CI]: 98.4–99.7%), 94.1% (95% CI: 85.6–98.4%) and 99.7% (95% CI: 99.0–100%), respectively. For anterior nasal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 98.9% (95% CI: 97.2–99.7%), 98.0% (95% CI: 89.6–100%) and 99.0% (95% CI: 97.2–99.8%), respectively. In total, 5 samples were positive in the reference real-time RT-PCR and negative in Smart Gene SARS-CoV-2, whereas 5 samples were negative in the reference real-time RT-PCR and positive in Smart Gene SARS-CoV-2. Conclusion Smart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.

scholarly journals Multiple-Centre Clinical Evaluation of Rapid Recombinase-Aided Amplification Assays for Five Pathogens

2021 ◽  
Author(s):  
Xin-xin Shen ◽  
Dan-wen Nie ◽  
Hong Zhang ◽  
Zhi-fei Zhan ◽  
Yuan Gao ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Reverse Transcription ◽  
Clinical Performance ◽  
Quantitative Polymerase Chain Reaction ◽  
Human Adenovirus ◽  
Molecular Diagnostic ◽  
Chain Reaction ◽  
Qrt Pcr ◽  
Polymerase Chain

Abstract Background: Recombinase-aided amplification(RAA) is a new, simple, and ultrafast isothermal molecular diagnostic technique performed within 30min at 39°C–42°C.In this study, we evaluated the clinical performance of four duplex RAA kits for hepatitis B virus(HBV), human adenovirus 3(HAdV3), human adenovirus 7(HAdV7), and Bordetella pertussis and one duplex reverse-transcription RAA (RT-RAA) kit for respiratory syncytial virus (RSV).Methods: A total of 392 sera and 374 respiratory tract samples were collected from five institutions in four China regions. Each RAA kit’s sensitivity and specificity were compared with those of real-time quantitative polymerase chain reaction(qPCR),real-time quantitative reverse-transcription polymerase chain reaction(qRT-PCR), or sequencing. Results: Compared with qPCR or qRT-PCR, the sensitivities of HBV RAA,RSV RT-RAA, and B.pertussis RAA were 97.55%,96.67%, and 100%,respectively,and all of the specificities were 100%.The total coincidence rates were 97.78%(383/392,95%CI:95.63%–98.85%),97.70%(212/217, 95%CI:94.57%–99.16%), and 100%(60/60,95%CI:92.80%–100%),respectively.The Kappa values were 0.977,0.947, and 1,respectively(P<0.05).Regarding the sequencing, the sensitivities of HAdV3 RAA and HAdV7 RAA were 100% and 97.37%, respectively,and all specificities were 100%.The total coincidence rates were 100%(97/97,95%CI:91.58%–100%) and 98.97%(96/97,95%CI:94.39%–99.82%),and the Kappa values were 1 and 0.978 (P<0.05),respectively.Conclusions: With comparable clinical performance, these RAA kits are suitable assays for rapidly detecting pathogens in resource-limited laboratories.

scholarly journals Clinical Evaluation of a Combo Rapid Antigen Test QuickNavi-Flu+COVID19 Ag for Simultaneous Detection of SARS-CoV-2 and Influenza Viruses

2021 ◽  
Author(s):  
Yuto Takeuchi ◽  
Yusaku Akashi ◽  
Yoshihiko Kiyasu ◽  
Norihiko Terada ◽  
Yoko Kurihara ◽  
...  
Keyword(s):  
Real Time ◽  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Simultaneous Detection ◽  
Influenza Viruses ◽  
Antigen Test ◽  
Sample Collection ◽  
Rt Pcr ◽  
The Real ◽  
Reverse Transcription Pcr

AbstractIntroductionSince respiratory sample collection is an uncomfortable experience, simultaneous detection of pathogens with a single swab is preferable. We prospectively evaluated the clinical performance of a newly developed antigen test QuickNavi-Flu+COVID19 Ag (Denka Co., Ltd., Tokyo, Japan) which can detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses at the same time with a single testing device.MethodsIncluded were those who were suspected of contracting coronavirus disease 2019 (COVID-19) and referred to a PCR center at Ibaraki prefecture in Japan, between August 2, 2021 to September 13, 2021, when the L452R mutant strains of SARS-CoV-2 were prevalent. Additional nasopharyngeal samples and anterior nasal samples were obtained for the antigen test and were compared with a reference reverse transcription PCR (RT-PCR) using nasopharyngeal samples.ResultsIn total, 1510 nasopharyngeal samples and 862 anterior nasal samples were evaluated. For SARS-CoV-2 detection in nasopharyngeal samples, the sensitivity and specificity of the antigen test were 80.9% and 99.8%, respectively. The sensitivity and specificity using anterior nasal samples were 67.8% and 100%, respectively. In symptomatic cases, the sensitivities increased to 88.3% with nasopharyngeal samples and 73.7% with anterior nasal samples. There were three cases of discrepant results between the antigen test and the real-time RT-PCR. All of them were positive with the antigen test but negative with the real-time RT-PCR in SARS-CoV-2 detection. During the study period, influenza viruses were not detected.ConclusionA combo kit, QuickNavi-Flu+COVID19 Ag, showed an acceptable sensitivity and sufficient specificity for SARS-CoV-2 detection, especially using nasopharyngeal sample collected from symptomatic patients.

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