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1.
J Clin Lab Anal ; 35(11): e24011, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1525448

ABSTRACT

BACKGROUND: Interleukin 6 assays are useful in early detection of infections and risk stratification of critically ill patients, so an assay with a short turnaround-time and near-patient use is preferred. This study evaluated the performance of a new interleukin 6 assay, Pylon IL-6 assay, and explored its potential use in near-patient settings. METHODS: We carried out imprecision, linearity and comparison studies using serum and plasma samples according to CLSI EP guidelines. The stability of whole blood samples during storage was assessed. Furthermore, whole blood samples from pediatric patients with suspected infection were measured to evaluate the assay's diagnostic performance. RESULTS: The within-run CVs and total CVs of Pylon IL-6 assay were determined as 1.8% and 3.0% at 159.3 pg/ml and 3.5% and 4.7% at 8009.9 pg/ml, respectively. The method showed linearity between 1.5 and 42,854 pg/ml. The results of serum samples measured by Pylon assays correlated to those measured by Roche assays, as well as to those of matched whole blood samples measured by Pylon assays. IL-6 in whole blood was found stable for ~8 h at room temperature. Pylon IL-6 results of whole blood samples from 179 pediatric patients with suspected infection showed an AUC of 0.842 in diagnosis of bacterial infection. The turnaround time of Pylon IL-6 assay was only 1 h when using whole blood samples. CONCLUSION: The new assay demonstrated performance comparable to those performed on clinical laboratory instruments and can be used in near-patient settings with whole blood to reduce turnaround times.


Subject(s)
Blood Chemical Analysis , Immunoassay , Interleukin-6/blood , Blood Chemical Analysis/methods , Blood Chemical Analysis/standards , Child , Child, Preschool , Female , Humans , Immunoassay/methods , Immunoassay/standards , Infant , Limit of Detection , Linear Models , Male , Reproducibility of Results
2.
Ann Clin Biochem ; 58(5): 411-421, 2021 09.
Article in English | MEDLINE | ID: covidwho-1181016

ABSTRACT

BACKGROUND: The COVID-19 pandemic has drastically changed the delivery of secondary care services. Self-collection of capillary blood at home can facilitate the monitoring of patients with chronic disease to support virtual clinics while mitigating the risk of SARS-CoV-2 infection and transmission. OBJECTIVE: To investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely used biochemical analytes and to develop and pilot a user-friendly home-collection kit to support virtual outpatient clinical services. METHODS: To investigate the comparability of whole blood capillary and plasma venous samples for 15 routinely requested biochemical analytes, simultaneous samples of venous and capillary blood were collected in EDTA and lithium-heparin plasma separation tubes that were of 4-6 mL and 400-600 µL draw volume, respectively. Venous samples were analysed within 4 h of collection while capillary samples were kept at ambient temperature for three days until centrifugation and analysis. Analyte results that were comparable between the matrices were then piloted in a feasibility study in three outpatient clinical services. RESULTS: HbA1c, lipid profile and liver function tests were considered comparable and piloted in the patient feasibility study. The home-collect kit demonstrated good patient usability. CONCLUSION: Home collection of capillary blood could be a clinically-useful tool to deliver virtual care to patients with chronic disease.


Subject(s)
Blood Chemical Analysis/methods , Blood Specimen Collection/methods , COVID-19/blood , Pandemics , SARS-CoV-2 , Adult , Blood Chemical Analysis/instrumentation , Blood Specimen Collection/instrumentation , Capillary Tubing , Feasibility Studies , Female , Humans , London , Male , Middle Aged , Phlebotomy/instrumentation , Phlebotomy/methods , Pilot Projects , Remote Consultation , Self Care/instrumentation , Self Care/methods , Surveys and Questionnaires
3.
Int J Mol Sci ; 22(5)2021 Mar 09.
Article in English | MEDLINE | ID: covidwho-1134169

ABSTRACT

Fibrinolysis is an important process in hemostasis responsible for dissolving the clot during wound healing. Plasmin is a central enzyme in this process via its capacity to cleave fibrin. The kinetics of plasmin generation (PG) and inhibition during fibrinolysis have been poorly understood until the recent development of assays to quantify these metrics. The assessment of plasmin kinetics allows for the identification of fibrinolytic dysfunction and better understanding of the relationships between abnormal fibrin dissolution and disease pathogenesis. Additionally, direct measurement of the inhibition of PG by antifibrinolytic medications, such as tranexamic acid, can be a useful tool to assess the risks and effectiveness of antifibrinolytic therapy in hemorrhagic diseases. This review provides an overview of available PG assays to directly measure the kinetics of plasmin formation and inhibition in human and mouse plasmas and focuses on their applications in defining the role of plasmin in diseases, including angioedema, hemophilia, rare bleeding disorders, COVID-19, or diet-induced obesity. Moreover, this review introduces the PG assay as a promising clinical and research method to monitor antifibrinolytic medications and screen for genetic or acquired fibrinolytic disorders.


Subject(s)
Blood Chemical Analysis/methods , Disease , Fibrinolysin/analysis , Fibrinolysin/metabolism , Animals , Antifibrinolytic Agents/blood , Fibrin/analysis , Fibrin/chemistry , Fibrinolytic Agents/blood , Humans , Plasminogen/analysis , Plasminogen/chemistry , Plasminogen/metabolism
5.
Clin Lab ; 67(2)2021 Feb 01.
Article in English | MEDLINE | ID: covidwho-1094346

ABSTRACT

BACKGROUND: COVID-19 has recently been declared an epidemic by the WHO, and there is an urgent need for affected countries and laboratories to assess and treat people at risk of COVID-19. A heat procedure has been suggested for specimen inactivation. This study was designed to evaluate the effect of serum heating on biochemical indexes, and providing a basis for accurate detection results of the COVID-19 patients. METHODS: We collected 29 normal cases of two tubes of 5 mL whole blood. One tube was analyzed directly, and the other was analyzed after heating at 56°C 30 minutes. RESULTS: A total of 34 serum biochemical index quantitative results were obtained, 28/34 indexes were not significantly affected by the heat inactivation and remained clinically interpretable. As the thermal inactivation for these indexes showed good correlation, ALB (p = 0.04, Pearson R = 0.91, 2.6% mean increase), CysC (p = 0.03, Pearson R = 0.98, 9.9% mean increase), CO2CP (p < 0.001, Pearson R = 0.96, 13% mean decrease), they were still inter-pretable. Four biochemical indexes ALP, CK, CK-MB, and insulin were inactivated and showed significant statistical differences (p < 0.001). CONCLUSIONS: Our study showed CK, CK-MB, ALP, and insulin were sensitive to heat and will be inhibited or degrade after heating, indicating that the rapid decrease of this indexes in the COVID-19 patients may be caused by sample heat inactivation. For safety and diagnostic accuracy, we recommend the use of a point-of-care device for blood gases, electrolytes, troponin, and liver and renal function tests within a ISL 2 or above biosafety cabinet with level 3 or above biosafety laboratory practice.


Subject(s)
Blood Chemical Analysis , COVID-19 , Diagnostic Errors/prevention & control , Hot Temperature/adverse effects , SARS-CoV-2 , Virus Inactivation , Alkaline Phosphatase/blood , Blood Chemical Analysis/methods , Blood Chemical Analysis/standards , COVID-19/blood , COVID-19/diagnosis , COVID-19/virology , Creatine Kinase/blood , Female , Humans , Insulin/blood , Male , Middle Aged , Point-of-Care Systems , SARS-CoV-2/isolation & purification , SARS-CoV-2/physiology , Sensitivity and Specificity
6.
Anal Sci ; 37(9): 1301-1304, 2021 Sep 10.
Article in English | MEDLINE | ID: covidwho-1094104

ABSTRACT

An in-hospital rapid method for quantifying the serum level of favipiravir (FPV) in the pharmacological treatment of COVID-19 was developed by an appropriate combination of a solid-phase extraction treatment and a reversed-phase HPLC/UV detection system. The quantification method was well-validated and applied to measuring the serum FPV level in a clinical practice at a general hospital that accepts COVID-19 patients. Furthermore, an analysis of data from our preliminary interaction analysis revealed, for the first time, that FPV selectively forms complexes with ferric (Fe3+) and cupric (Cu2+) ions.


Subject(s)
Amides/blood , Blood Chemical Analysis/methods , COVID-19/drug therapy , Hospitals , Pyrazines/blood , Amides/therapeutic use , COVID-19/blood , Chromatography, High Pressure Liquid , Humans , Pyrazines/therapeutic use , Time Factors
7.
Aging (Albany NY) ; 13(3): 3176-3189, 2021 02 09.
Article in English | MEDLINE | ID: covidwho-1076957

ABSTRACT

To establish an effective nomogram for predicting in-hospital mortality of COVID-19, a retrospective cohort study was conducted in two hospitals in Wuhan, China, with a total of 4,086 hospitalized COVID-19 cases. All patients have reached therapeutic endpoint (death or discharge). First, a total of 3,022 COVID-19 cases in Wuhan Huoshenshan hospital were divided chronologically into two sets, one (1,780 cases, including 47 died) for nomogram modeling and the other (1,242 cases, including 22 died) for internal validation. We then enrolled 1,064 COVID-19 cases (29 died) in Wuhan Taikang-Tongji hospital for external validation. Independent factors included age (HR for per year increment: 1.05), severity at admission (HR for per rank increment: 2.91), dyspnea (HR: 2.18), cardiovascular disease (HR: 3.25), and levels of lactate dehydrogenase (HR: 4.53), total bilirubin (HR: 2.56), blood glucose (HR: 2.56), and urea (HR: 2.14), which were finally selected into the nomogram. The C-index for the internal resampling (0.97, 95% CI: 0.95-0.98), the internal validation (0.96, 95% CI: 0.94-0.98), and the external validation (0.92, 95% CI: 0.86-0.98) demonstrated the fair discrimination ability. The calibration plots showed optimal agreement between nomogram prediction and actual observation. We established and validated a novel prognostic nomogram that could predict in-hospital mortality of COVID-19 patients.


Subject(s)
COVID-19 , Hospital Mortality , Nomograms , Age Factors , Aged , Blood Chemical Analysis/methods , Blood Chemical Analysis/statistics & numerical data , COVID-19/blood , COVID-19/diagnosis , COVID-19/mortality , COVID-19/physiopathology , Cardiovascular Diseases/epidemiology , China/epidemiology , Female , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Prognosis , Retrospective Studies , Risk Assessment/methods , Risk Factors , SARS-CoV-2/isolation & purification , Severity of Illness Index , Survival Analysis , Symptom Assessment/methods , Symptom Assessment/statistics & numerical data
8.
Spectrochim Acta A Mol Biomol Spectrosc ; 249: 119241, 2021 Mar 15.
Article in English | MEDLINE | ID: covidwho-1065570

ABSTRACT

The present work describes development of rapid, robust, sensitive and green spectrofluorimetric method for determination of favipiravir (FAV). Different factors affecting fluorescence were carefully studied and Box Behnken Design was applied to optimize experimental parameters. The proposed method is based on measuring native fluorescence of FAV in 0.2 M borate buffer (pH 8.0) at 432 nm after excitation at 361 nm. There was a linear relationship between FAV concentration and relative fluorescence intensity over the range 40-280 ng/mL with limit of detection of 9.44 ng/mL and quantitation limit of 28.60 ng/mL. The method was successfully implemented for determination of FAV in its pharmaceutical formulation with mean % recovery of 99.26 ± 0.87. Moreover, the high sensitivity of the method allowed determination of FAV in spiked human plasma over a range of 48-192 ng/mL. The proposed spectrofluorimetric method was proved to be eco-friendly according to analytical eco-scale.


Subject(s)
Amides/blood , Antiviral Agents/blood , COVID-19/blood , COVID-19/drug therapy , Pyrazines/blood , Spectrometry, Fluorescence/methods , Amides/analysis , Amides/therapeutic use , Antiviral Agents/analysis , Antiviral Agents/therapeutic use , Blood Chemical Analysis/methods , Blood Chemical Analysis/statistics & numerical data , Humans , Limit of Detection , Pyrazines/analysis , Pyrazines/therapeutic use , SARS-CoV-2 , Sensitivity and Specificity , Spectrometry, Fluorescence/statistics & numerical data
9.
Clin Chem Lab Med ; 59(2): 421-431, 2020 10 21.
Article in English | MEDLINE | ID: covidwho-881170

ABSTRACT

Objectives: The rRT-PCR test, the current gold standard for the detection of coronavirus disease (COVID-19), presents with known shortcomings, such as long turnaround time, potential shortage of reagents, false-negative rates around 15-20%, and expensive equipment. The hematochemical values of routine blood exams could represent a faster and less expensive alternative. Methods: Three different training data set of hematochemical values from 1,624 patients (52% COVID-19 positive), admitted at San Raphael Hospital (OSR) from February to May 2020, were used for developing machine learning (ML) models: the complete OSR dataset (72 features: complete blood count (CBC), biochemical, coagulation, hemogasanalysis and CO-Oxymetry values, age, sex and specific symptoms at triage) and two sub-datasets (COVID-specific and CBC dataset, 32 and 21 features respectively). 58 cases (50% COVID-19 positive) from another hospital, and 54 negative patients collected in 2018 at OSR, were used for internal-external and external validation. Results: We developed five ML models: for the complete OSR dataset, the area under the receiver operating characteristic curve (AUC) for the algorithms ranged from 0.83 to 0.90; for the COVID-specific dataset from 0.83 to 0.87; and for the CBC dataset from 0.74 to 0.86. The validations also achieved good results: respectively, AUC from 0.75 to 0.78; and specificity from 0.92 to 0.96. Conclusions: ML can be applied to blood tests as both an adjunct and alternative method to rRT-PCR for the fast and cost-effective identification of COVID-19-positive patients. This is especially useful in developing countries, or in countries facing an increase in contagions.


Subject(s)
Blood Chemical Analysis/methods , COVID-19 Testing/methods , COVID-19/blood , Hematologic Tests/methods , Machine Learning , Algorithms , Area Under Curve , Blood Cell Count , Datasets as Topic , Humans , SARS-CoV-2 , Sensitivity and Specificity
10.
Molecules ; 25(16)2020 Aug 13.
Article in English | MEDLINE | ID: covidwho-822410

ABSTRACT

Quantification of lactate/lactic acid in critical care environments is essential as lactate serves as an important biochemical marker for the adequacy of the haemodynamic circulation in shock and of cell respiration at the onset of sepsis/septic shock. Hence, in this study, ATR-FTIR was explored as a potential tool for lactate measurement, as the current techniques depend on sample preparation and fails to provide rapid response. Moreover, the effects of pH on PBS samples (7.4, 7, 6.5 and 6) and change in solution conditions (PBS to whole blood) on spectral features were also investigated. A total 189 spectra from five sets of lactate containing media were obtained. Results suggests that lactate could be measured with more than 90% accuracy in the wavenumber range of 1500-600 cm-1. The findings of this study further suggest that there exist no effects of change in pH or media, when estimating lactate concentration changes in this range of the Mid-IR spectral region.


Subject(s)
Blood Chemical Analysis/methods , Lactic Acid/blood , Spectroscopy, Fourier Transform Infrared , Analytic Sample Preparation Methods , Animals , Hydrogen-Ion Concentration , Sheep , Time Factors
11.
Br J Haematol ; 189(3): 391-392, 2020 05.
Article in English | MEDLINE | ID: covidwho-793685
12.
Clin Chem Lab Med ; 58(12): 2047-2061, 2020 09 13.
Article in English | MEDLINE | ID: covidwho-760723

ABSTRACT

Objectives Hydroxychloroquine (HCQ) is an anti-malarial and immunomodulatory drug reported to inhibit the Corona virus, SARS-CoV-2, in vitro. At present there is insufficient evidence from clinical trials to determine the safety and efficacy of HCQ as a treatment for COVID-19. However, since the World Health Organisation declared COVID-19 a pandemic in March 2020, the US Food and Drug Administration issued an Emergency Use Authorisation to allow HCQ and Chloroquine (CQ) to be distributed and used for certain hospitalised patients with COVID-19 and numerous clinical trials are underway around the world, including the UK based RECOVERY trial, with over 1000 volunteers. The validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of HCQ and two of its major metabolites, desethylchloroquine (DCQ) and di-desethylchloroquine (DDCQ), in whole blood is described. Methods Blood samples were deproteinised using acetonitrile. HCQ, DCQ and DDCQ were chromatographically separated on a biphenyl column with gradient elution, at a flow rate of 500 µL/min. The analysis time was 8 min. Results For each analyte linear calibration curves were obtained over the concentration range 50-2000 µg/L, the lower limit of quantification (LLOQ) was 13 µg/L, the inter-assay relative standard deviation (RSD) was <10% at 25, 800 and 1750 µg/L and mean recoveries were 80, 81, 78 and 62% for HCQ, d4-HCQ, DCQ and DDCQ, respectively. Conclusion This method has acceptable analytical performance and is applicable to the therapeutic monitoring of HCQ, evaluating the pharmacokinetics of HCQ in COVID-19 patients and supporting clinical trials.


Subject(s)
Blood Chemical Analysis/methods , Chromatography, High Pressure Liquid , Hydroxychloroquine/blood , Hydroxychloroquine/metabolism , Tandem Mass Spectrometry , Calibration , Humans , Limit of Detection , Time Factors
13.
Clin Chem Lab Med ; 58(8): 1191-1199, 2020 Jul 28.
Article in English | MEDLINE | ID: covidwho-324469

ABSTRACT

Coronavirus disease 2019 (COVID-19) represents a new pandemic caused by severe acute respiratory syndrome virus coronavirus 2 (SARS-CoV-2). A previous pooled analysis clearly identified elevated D-dimer levels as being associated with severity of COVID-19. Since then, several other studies have provided clearer support for this initial evidence. However, potentially under-recognized by those reporting on D-dimer is the considerable variation in reporting units for D-dimer, and thus also the potential for misreporting of D-dimer data based on poor or incomplete reporting. A PubMed search was used to identify recent papers reporting on D-dimers in COVID-19-based studies. We report that: (1) most publications did not identify either the manufacturer or D-dimer product used; (2) most did not identify whether D-dimer values were reported as D-dimer units (DDU) or fibrinogen equivalent units (FEU) (~2 × differences); (3) nearly half did not identify normal cut-off values; (4) some did not report numerical findings or units for D-dimer; (5) where reported, most identified units as either mg/L or µg/mL; (6) we identified at least four errors in reporting from 21 papers. It may not be possible to truly standardize D-dimer assays, but it should be feasible to harmonize D-dimer assays to a single unit of measurement.


Subject(s)
Blood Chemical Analysis/statistics & numerical data , Coronavirus Infections/blood , Fibrin Fibrinogen Degradation Products/analysis , Pneumonia, Viral/blood , Betacoronavirus , Blood Chemical Analysis/methods , COVID-19 , Communication , Confusion , Humans , Pandemics , SARS-CoV-2
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