Use of dried blood spot samples for SARS-CoV-2 antibody detection using the Roche Elecsys ® high throughput immunoassay

AbstractBackgroundDried blood spot samples (DBS) provide an alternative sample type to venous blood samples for antibody testing. DBS are used by NHS for diagnosing HCV and by PHE for large scale HIV and Hepatitis C serosurveillance; the applicability of DBS based approaches to SARS-CoV-2 antibody detection is uncertain.ObjectiveTo compare antibody detection in dried blood spot eluates using the Roche Elecsys ® immunoassay (index test) with antibody detection in paired plasma samples, using the same assay (reference test).SettingOne Police and one Fire & Rescue facility in England.Participants195 participants within a larger sample COVID-19 serodiagnostics study of keyworkers, EDSAB-HOME.Outcome MeasuresSensitivity and specificity of DBS (the index test) relative to plasma (the reference test), at an experimental cut-off; quality of DBS sample collected; estimates of relative sensitivity of DBS vs. plasma immunoassay in a larger population.Results18/195 (9.2%) participants tested positive using plasma samples. DBS sample quality varied markedly by phlebotomist, and low sample volume significantly reduced immunoassay signals. Using a cut-off of ten median absolute deviations above the immunoassay result with negative samples, sensitivity and specificity of DBS were 89.0% (95% CI 67.2, 96.9%) and 100.0% (95% CI 97.9, 100%) respectively compared with using plasma. The limit of detection for DBS is about 30 times higher than for plasma.ConclusionDBS use for SARS-CoV-2 serology, though feasible, is insensitive relative to immunoassays on plasma. Sample quality impacts on assay performance. Alternatives, including the collection of capillary blood samples, should be considered for screening programs.

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Use of dried blood spot samples for SARS-CoV-2 antibody detection using the Roche Elecsys ® high throughput immunoassay

Journal of Clinical Virology ◽

10.1016/j.jcv.2021.104739 ◽

2021 ◽

Vol 136 ◽

pp. 104739

Author(s):

Ranya Mulchandani ◽

Ben Brown ◽

Tim Brooks ◽

Amanda Semper ◽

Nicholas Machin ◽

...

Keyword(s):

High Throughput ◽

Dried Blood Spot ◽

Antibody Detection ◽

Blood Spot

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Development and validation of a dried blood spot–HPLC assay for the determination of metronidazole in neonatal whole blood samples

Analytical and Bioanalytical Chemistry ◽

10.1007/s00216-010-3571-5 ◽

2010 ◽

Vol 397 (2) ◽

pp. 687-693 ◽

Cited By ~ 42

Author(s):

Maysa Faisal Suyagh ◽

Godwill Iheagwaram ◽

Prashant Laxman Kole ◽

Jeff Millership ◽

Paul Collier ◽

...

Keyword(s):

Whole Blood ◽

Dried Blood Spot ◽

Hplc Assay ◽

Blood Samples ◽

Whole Blood Samples ◽

Development And Validation ◽

Blood Spot

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Development and validation of a LC-MS/MS method for ivermectin quantification in dried blood spots: application to a pharmacokinetic study inTrichuris trichiura-infected adults

Analytical Methods ◽

10.1039/c8ay00828k ◽

2018 ◽

Vol 10 (24) ◽

pp. 2901-2909 ◽

Cited By ~ 5

Author(s):

Jessica D. Schulz ◽

Anna Neodo ◽

Jean T. Coulibaly ◽

Jennifer Keiser

Keyword(s):

Pharmacokinetic Study ◽

Dried Blood Spots ◽

Trichuris Trichiura ◽

Dried Blood Spot ◽

Plasma Samples ◽

Blood Spots ◽

Development And Validation ◽

Blood Spot

Ivermectin was quantified in dried blood spot and plasma samples derived fromTrichuris trichiura-infected adults with a validated LC-MS/MS method.

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Validation and clinical application of dried blood spot assay for quantitative assessment of edoxaban in healthy adults

Bioanalysis ◽

10.4155/bio-2019-0180 ◽

2020 ◽

Vol 12 (6) ◽

pp. 393-407

Author(s):

Ling He ◽

Roohi Gajee ◽

Raj Mangaraj ◽

Michael P Waldron ◽

Karen S Brown

Keyword(s):

Healthy Subjects ◽

Quantitative Assessment ◽

Dried Blood Spot ◽

Plasma Samples ◽

Open Label ◽

Finger Prick ◽

Incurred Sample Reanalysis ◽

Alternative Methodology ◽

Blood Spot ◽

Sampling Approach

Aim: Dried blood spot (DBS) is a sampling approach that offers several advantages over plasma and whole blood (WB) sampling, but several factors, such as hematocrit and temperature, can adversely affect quantitation. Methodology & results: In an open-label, three-way crossover study in healthy subjects, we explored the correlation between DBS, WB and plasma samples, and between DBS samples from finger-prick and venipuncture blood for measuring edoxaban and its metabolite M-4 using LC–MS/MS. The methods were validated comprehensively. The incurred sample reanalysis experiments demonstrated quantitation reproducibility in all three matrices. Overall, there was a good correlation (near perfect concordance for edoxaban) among plasma, WB and DBS measurements. M-4 concentrations in DBS and WB were lower than in plasma. Conclusion: These results indicate using DBS may be used as an alternative methodology to measure edoxaban pharmacokinetics.

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PKP-014 Dried blood spot sampling of nilotinib in patients with chronic myeloid leukaemia: a comparison with venous blood samples

European Journal of Hospital Pharmacy ◽

10.1136/ejhpharm-2013-000436.349 ◽

2014 ◽

Vol 21 (Suppl 1) ◽

pp. A142.1-A142

Author(s):

AM Schimmel ◽

CCLM Boons ◽

A Chahbouni ◽

AJ Wilhelm ◽

YM Den Hartog ◽

...

Keyword(s):

Chronic Myeloid Leukaemia ◽

Myeloid Leukaemia ◽

Venous Blood ◽

Dried Blood Spot ◽

Blood Samples ◽

Blood Spot

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Evaluation of a novel dried blood spot collection device (HemaSpot™) to test blood samples collected from dogs for antibodies to Leishmania infantum

Veterinary Parasitology ◽

10.1016/j.vetpar.2014.07.031 ◽

2014 ◽

Vol 205 (1-2) ◽

pp. 338-342 ◽

Cited By ~ 11

Author(s):

Alexa C. Rosypal ◽

Leanne D. Pick ◽

Jaime O. Esquivel Hernandez ◽

David S. Lindsay

Keyword(s):

Leishmania Infantum ◽

Dried Blood Spot ◽

Blood Samples ◽

Collection Device ◽

Blood Spot

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Measurement of total homocysteine in plasma and blood spots using liquid chromatography-tandem mass spectrometry: comparison with the plasma Abbott IMx method

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1258/000456303763046094 ◽

2003 ◽

Vol 40 (2) ◽

pp. 161-165 ◽

Cited By ~ 26

Author(s):

Steven J. McCann ◽

Scott Gillingwater ◽

Brian G. Keevil ◽

Donald P. Cooper ◽

Michel R. Morris

Keyword(s):

Sensitivity And Specificity ◽

Plasma Concentrations ◽

Dried Blood Spots ◽

Dried Blood Spot ◽

Tandem Mass ◽

Blood Spots ◽

Plasma Thcy ◽

Total Homocysteine ◽

Tandem Mass Spectrometric ◽

Blood Spot

Background: Current sampling for total homocysteine (tHcy) is problematic, requiring plasma separation within 15 min. The aim of this study was to develop a liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for the measurement of tHcy in plasma and dried blood spots and to determine whether the dried blood spot concentration could be used to predict plasma concentrations of tHcy. Methods: LC-MS/MS methodology was optimized to measure tHcy in plasma and dried blood spots. Fifty blood samples collected from heart transplant patients were used to form dried blood spots and for plasma analysis. Plasma tHcy was also measured using the Abbott IMx1 method and values were compared to the tHcy concentrations determined in plasma and dried blood spots using LC-MS/MS methodology. Results: The plasma tHcy LC-MS/MS results compared well with the IMx values: LC-MS/MS=1·18(IMx)-0·44 ( r2=0·915). The within-batch precision ( n =10) of the plasma LC-MS/MS method was < 2·0% at 14·6 and 37·7 µmol/L, respectively; the between-batch precision ( n=10) was 5·0 and 8·0%, respectively, at these concentrations. The method was found to be sensitive down to 1 µmol/L and linear up to at least 100 µmol/L. Dried blood spot LC-MS/MS results were considerably lower than the plasma IMx values ( P < 0·0001): dried blood spot LC-MS/MS=0·33IMx+1·77 ( r2=0·682). The within-batch precision ( n=20) of the dried blood spot LC-MS/MS method was 7·3% and 4·7% at concentrations of 4·0 and 7·9 µmol/L, respectively; the between-batch precision was 12·6% and 7·9% at concentrations of 5·1 and 8·0 µmol/L, respectively. To assess whether dried blood spots are suitable as a screening test to predict plasma tHcy concentrations, arbitary cut-off levels were compared. If it is assumed that a plasma tHcy concentration of >15 µmol/L is raised, a dried blood spot result of >6·8 µmol/L has a sensitivity and specificity in detecting a raised plasma tHcy of 83·3% and 96·2%, respectively, and a positive and negative predictive value of 95% and 86%, respectively, with an efficiency of 90%. Use of a dried blood spot cut-off concentration of 6·2 µmol/L for predicting high plasma tHcy concentrations (above 15 µmol/L) has a sensitivity and specificity of 95·8% and 73·1%, respectively, positive and negative predictive values of 76% and 95%, respectively, and an efficiency of 84%. Conclusions: We have developed a precise and accurate LC-MS/MS method for measuring plasma tHcy concentrations, which uses a small volume of plasma and is suitable for routine use. A satisfactory LC-MS/MS method for the measurement of tHcy in dried blood spots was also developed; this method might be useful in routine screening for raised plasma concentrations of tHcy.

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