TL;DR: A rapid and simple point‐of‐care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS‐CoV‐2 virus in human blood within 15 minutes which can detect patients at different infection stages is developed.
Abstract: The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.
TL;DR: The development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semiquantitative measurement of AST and ALT in a fingerstick specimen is described, suggesting that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings.
Abstract: In developed nations, monitoring for drug-induced liver injury via serial measurements of serum transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) in at-risk individuals is the standard of care. Despite the need, monitoring for drug-related hepatotoxicity in resource-limited settings is often limited by expense and logistics, even for patients at highest risk. This manuscript describes the development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semi-quantitative measurement of AST and ALT in a fingerstick specimen. Using 223 clinical specimens obtained by venipuncture and 10 fingerstick specimens from healthy volunteers, we have shown that our assay can, in 15 minutes, provide visual measurements of AST and ALT in whole blood or serum which allow the user to place those values into one of three readout “bins” ( 5x ULN, corresponding to tuberculosis/HIV treatment guidelines) with >90% accuracy. These data suggest that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings.
TL;DR: A paper-based microfluidic device that measures two enzymatic markers of liver function and total serum protein and shows standard deviations in calibration runs and "spiked" standards that are acceptable for routine clinical use is described.
Abstract: This paper describes a paper-based microfluidic device that measures two enzymatic markers of liver function (alkaline phosphatase, ALP, and aspartate aminotransferase, AST) and total serum protein. A device consists of four components: (i) a top plastic sheet, (ii) a filter membrane, (iii) a patterned paper chip containing the reagents necessary for analysis, and (iv) a bottom plastic sheet. The device performs both the sample preparation (separating blood plasma from erythrocytes) and the assays; it also enables both qualitative and quantitative analysis of data. The data obtained from the paper-microfluidic devices show standard deviations in calibration runs and “spiked” standards that are acceptable for routine clinical use. This device illustrates a type of test useable for a range of assays in resource-poor settings.
TL;DR: In this paper, a prospective study was conducted to assess the diagnostic usefulness of non-invasive testing for antibody to the leishmanial antigen K39 by means of antigen-impregnated nitrocellulose paper strips adapted for use under field conditions.
TL;DR: Measurements with the FreeStyle Navigator system were found to be consistent and accurate compared with venous measurements made using a laboratory reference method over 5 days of sensor wear.
Abstract: OBJECTIVE: To assess the accuracy of the FreeStyle Navigator® Continuous Glucose Monitoring System measurements of glucose in interstitial fluid in comparison with Yellow Springs Instrument (YSI) laboratory reference measurements of venous blood glucose. RESEARCH DESIGN AND METHODS: Fifty-eight subjects with type 1 diabetes, ages 18 to 64 years, were enrolled in a multi-center, prospective, single-arm study. Each subject wore two sensors simultaneously which were calibrated with capillary fingerstick measurements at 10, 12, 24, and 72 hours after insertion. Measurements from the FreeStyle Navigator system were collected at one-minute intervals and compared with venous measurements taken once every 15 minutes for 50 hours over the five-day sensor wear in an in-patient clinical research center. Periods of high rates of change of glucose were induced by insulin and glucose challenges. RESULTS: Comparison of the FreeStyle Navigator measurements with the laboratory reference method (n=20,362) gave mean and median absolute relative differences (ARD) of 12.8% and 9.3% respectively. The percentage in the clinically-accurate Clarke error grid A zone was 81.7% and 16.7% in the benign error B zone. During low rates of change (less than ±1 mg/dL/min), the percentage in the A zone was higher (84.9%) and the mean and median ARD were lower (11.7% and 8.5%, respectively). CONCLUSIONS: The FreeStyle Navigator system was found to be consistent and accurate compared with venous measurements made using a laboratory reference method over five days of sensor wear (82.5% in the A zone on day one, 80.9% on day five).