Objective: To examine the correlation between plasma hCG results obtained with the new i-STAT® hCG point of care test with those concomitantly obtained from the central hospital laboratory utilizing the same pa...Objective: To examine the correlation between plasma hCG results obtained with the new i-STAT® hCG point of care test with those concomitantly obtained from the central hospital laboratory utilizing the same patient samples. Methods: Prospective cross-sectional laboratory test evaluation. We compared plasma hCG results obtained with the i-STAT® hCG test (Abbott Point of Care, Princeton, NJ, USA) with Architect Ci8200 (Abbott Laboratories, Abbott Park, IL, USA). We also calculated the total coefficient of variation (CV) for the i-STAT® method. Results: The two methods showed a good linear correlation (R2 = 0.994;slope 1.03) and CV for the i-STAT® method was 2.1% - 5.2%. Conclusion: We suggest that the i-STAT® hCG blood assay could be used as a complement to urine hCG assays in clinical situations when rapid test results are needed and urine is not available.展开更多
This device is aimed at ensuring that the sample is uniformly and equivalently reacted with the antibody on the NC membrane in each test when the microfluidic liquid system is introduced to the chip.In this study,the ...This device is aimed at ensuring that the sample is uniformly and equivalently reacted with the antibody on the NC membrane in each test when the microfluidic liquid system is introduced to the chip.In this study,the developed microfluidic chip can avoid the presence of the sample and conjugate pads in the chip,while the precision of the chro matography system can be greatly improved using the same particles,NC membrane and antibody alongside the traditional strip.The results,taking the detection of cTnI as an example,revealed that the coefficient of variation(CV)is controlled within 4%,while the maximum record of the contrast chromatographic reagent strip can reach 15%.Additionally,the detection sensitivity can maintain the same order of magnitudes with that of the traditional chromatographic strip.With the results,the determination correlation of the developed microfluidic chip has been greatly improved.In addition,the CV of the chip in this study is greatly improved in comparison with that of the traditional strip.The biggest improvement lies in the mixing between the sample and the microspheres,indicating that this is a new approach to improve the CV of the traditional strip.展开更多
Precision and repeatability are challenging issues in point of care testing(POCT) analysis. Herein, we proposed a lateral flow assay(LFA) based on internal quality control microspheres to realize the accurate diagnosi...Precision and repeatability are challenging issues in point of care testing(POCT) analysis. Herein, we proposed a lateral flow assay(LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbAlc in human body. Fluorescein cy5 decorated microspheres are used as labels for HbAlc detection, and BSA-fluorescein isothiocyanate(FITC) decorated microspheres are used as internal quality control labels. One test line was employed in the strip for the detection of glycosylated hemoglobin(HbAlc). This method can eliminate the interference of environmental factors(temperature, humidity,etc.) to LFA in the process of chromatography, and improve the precision and accuracy of HbAlc detection.The CV for detection of low concentration HbAlc was 1.05%, and the CV for detection of high concentration HbAlc was 0.69%. We envision the method to have great prospect in in vitro diagnosis(IVD).展开更多
A paper analytical device(PAD)was developed for the colourimetric estimation of alkaline phosphatase(ALP).ALP catalyzes the hydrolysis of disodium phenyl phosphate(DSPP)to phenol,which then undergoes oxidative couplin...A paper analytical device(PAD)was developed for the colourimetric estimation of alkaline phosphatase(ALP).ALP catalyzes the hydrolysis of disodium phenyl phosphate(DSPP)to phenol,which then undergoes oxidative coupling with 4-aminoantipyrine(4-AAP)producing a reddish brown-coloured quinone imine.The colourimetric reaction tested in solution has been translated onto a PAD for the point of care(PoC)testing of ALP.A uniform colour was obtained in 25 min with the introduction of ALP onto the reagent drop cast paper device.The images obtained by scanning the PAD were processed using ImageJ software.The colour intensity obtained by image processing was proportional to the concentration of ALP present in the sample.ALP in serum and saliva samples were tested using the PAD in the range of 0 to 528 U/L and 0 to 187 U/L,respectively.The interference studies revealed that the PAD was selective to ALP in the presence of other biomolecules.The PAD exhibited a limit of detection(LOD)of 3.3 U/L and a sensitivity of 48.36 a.u/Log(U/L)for serum ALP and LOD of 1.69 U/L and a sensitivity of 28.5 a.u/Log(U/L)for salivary ALP.The PAD showed good agreement with the clinical methods for real samples.展开更多
Laboratory medicine is an essential part of the diagnostic process,supporting clinical decisions,guiding and addressing therapy.The recent COVID-19 pandemic illustrated well the key role of laboratory medicine in the ...Laboratory medicine is an essential part of the diagnostic process,supporting clinical decisions,guiding and addressing therapy.The recent COVID-19 pandemic illustrated well the key role of laboratory medicine in the diagnosis,management and prognosis of SARS-CoV-2 infected patients.Technological advances improved the laboratory diagnosis and patients’management and others appear very promising as clustered regularly interspaced short palindromic repeats(CRISPR)or artificial intelligence(AI).This review describes the current diagnostic assays routinely used in laboratory as well as the novel technologies not in routine yet but that represent future directions and will probably dominate the laboratory in the next years.Serology is important for detecting antibodies and/or antigens of the infectious pathogens or for epidemiological purposes,while real-time PCR with its high sensitivity and specificity has a key role in pathogen detection in different biological matrices and in monitoring the therapy.Nanochip-based technologies make possible delivering a laboratory report at the patient’s bed or in settings where a laboratory-based hospital is not available.Next generation sequencing(NGS)is a massively high throughput parallel sequencing technology that allows the simultaneous sequence of billions of DNA fragments in a short time frame.This technology can be used to detect drug-associated mutations,minority species within an infected patient or for pathogen identification.CRISPR-based technology is a fast and accurate diagnostic method that can be applied to different human diseases including infectious diseases.Artificial intelligence is increasingly used in laboratory medicine.In clinical microbiology,it is used to build up diagnosis analyzing genomic information or mass spectra from isolated bacteria,for predicting antibiotic sensitivity or for processing in a short time a large number of images with meaningful results.Thus,the laboratory is becoming increasingly automated and interwoven with sophisticated software or algorithms that will increase the sensitivity and specificity of diagnoses,besides reducing time to results.展开更多
文摘Objective: To examine the correlation between plasma hCG results obtained with the new i-STAT® hCG point of care test with those concomitantly obtained from the central hospital laboratory utilizing the same patient samples. Methods: Prospective cross-sectional laboratory test evaluation. We compared plasma hCG results obtained with the i-STAT® hCG test (Abbott Point of Care, Princeton, NJ, USA) with Architect Ci8200 (Abbott Laboratories, Abbott Park, IL, USA). We also calculated the total coefficient of variation (CV) for the i-STAT® method. Results: The two methods showed a good linear correlation (R2 = 0.994;slope 1.03) and CV for the i-STAT® method was 2.1% - 5.2%. Conclusion: We suggest that the i-STAT® hCG blood assay could be used as a complement to urine hCG assays in clinical situations when rapid test results are needed and urine is not available.
基金financially supported by National Natural Science Foundation of China(Nos.81902153,61871180,62071119 and 61971187)Jiangsu Provincial Key Research and Development Program(No.BE 2018695)。
文摘This device is aimed at ensuring that the sample is uniformly and equivalently reacted with the antibody on the NC membrane in each test when the microfluidic liquid system is introduced to the chip.In this study,the developed microfluidic chip can avoid the presence of the sample and conjugate pads in the chip,while the precision of the chro matography system can be greatly improved using the same particles,NC membrane and antibody alongside the traditional strip.The results,taking the detection of cTnI as an example,revealed that the coefficient of variation(CV)is controlled within 4%,while the maximum record of the contrast chromatographic reagent strip can reach 15%.Additionally,the detection sensitivity can maintain the same order of magnitudes with that of the traditional chromatographic strip.With the results,the determination correlation of the developed microfluidic chip has been greatly improved.In addition,the CV of the chip in this study is greatly improved in comparison with that of the traditional strip.The biggest improvement lies in the mixing between the sample and the microspheres,indicating that this is a new approach to improve the CV of the traditional strip.
基金supported by the State key Basic Research Program of the PRC(No.2014CB744501)the National Key Research and Development Program of China(No.2017YFA0205301)+1 种基金the National Natural Science Foundation of China(Nos.61527806,61471168 and 61871180)open Funding of State Key Laboratory of Oral Diseases(No.SKLOD20180F02)
文摘Precision and repeatability are challenging issues in point of care testing(POCT) analysis. Herein, we proposed a lateral flow assay(LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbAlc in human body. Fluorescein cy5 decorated microspheres are used as labels for HbAlc detection, and BSA-fluorescein isothiocyanate(FITC) decorated microspheres are used as internal quality control labels. One test line was employed in the strip for the detection of glycosylated hemoglobin(HbAlc). This method can eliminate the interference of environmental factors(temperature, humidity,etc.) to LFA in the process of chromatography, and improve the precision and accuracy of HbAlc detection.The CV for detection of low concentration HbAlc was 1.05%, and the CV for detection of high concentration HbAlc was 0.69%. We envision the method to have great prospect in in vitro diagnosis(IVD).
基金Department of Biotechnology,Ministry of Science and Technology,India,102/IFD/SAN/1555/2018-2019,102/IFD/SAN/2238/2016-17
文摘A paper analytical device(PAD)was developed for the colourimetric estimation of alkaline phosphatase(ALP).ALP catalyzes the hydrolysis of disodium phenyl phosphate(DSPP)to phenol,which then undergoes oxidative coupling with 4-aminoantipyrine(4-AAP)producing a reddish brown-coloured quinone imine.The colourimetric reaction tested in solution has been translated onto a PAD for the point of care(PoC)testing of ALP.A uniform colour was obtained in 25 min with the introduction of ALP onto the reagent drop cast paper device.The images obtained by scanning the PAD were processed using ImageJ software.The colour intensity obtained by image processing was proportional to the concentration of ALP present in the sample.ALP in serum and saliva samples were tested using the PAD in the range of 0 to 528 U/L and 0 to 187 U/L,respectively.The interference studies revealed that the PAD was selective to ALP in the presence of other biomolecules.The PAD exhibited a limit of detection(LOD)of 3.3 U/L and a sensitivity of 48.36 a.u/Log(U/L)for serum ALP and LOD of 1.69 U/L and a sensitivity of 28.5 a.u/Log(U/L)for salivary ALP.The PAD showed good agreement with the clinical methods for real samples.
文摘Laboratory medicine is an essential part of the diagnostic process,supporting clinical decisions,guiding and addressing therapy.The recent COVID-19 pandemic illustrated well the key role of laboratory medicine in the diagnosis,management and prognosis of SARS-CoV-2 infected patients.Technological advances improved the laboratory diagnosis and patients’management and others appear very promising as clustered regularly interspaced short palindromic repeats(CRISPR)or artificial intelligence(AI).This review describes the current diagnostic assays routinely used in laboratory as well as the novel technologies not in routine yet but that represent future directions and will probably dominate the laboratory in the next years.Serology is important for detecting antibodies and/or antigens of the infectious pathogens or for epidemiological purposes,while real-time PCR with its high sensitivity and specificity has a key role in pathogen detection in different biological matrices and in monitoring the therapy.Nanochip-based technologies make possible delivering a laboratory report at the patient’s bed or in settings where a laboratory-based hospital is not available.Next generation sequencing(NGS)is a massively high throughput parallel sequencing technology that allows the simultaneous sequence of billions of DNA fragments in a short time frame.This technology can be used to detect drug-associated mutations,minority species within an infected patient or for pathogen identification.CRISPR-based technology is a fast and accurate diagnostic method that can be applied to different human diseases including infectious diseases.Artificial intelligence is increasingly used in laboratory medicine.In clinical microbiology,it is used to build up diagnosis analyzing genomic information or mass spectra from isolated bacteria,for predicting antibiotic sensitivity or for processing in a short time a large number of images with meaningful results.Thus,the laboratory is becoming increasingly automated and interwoven with sophisticated software or algorithms that will increase the sensitivity and specificity of diagnoses,besides reducing time to results.
