roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen...

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Proteins | Peptides Analytes IGF-1 Study 1 | Study 2 rheumatoid factors | anti-IgM RF, anti-IgA RF, anti-CCP, anti-MCV Volumetric Absorptive Micro Sampler (VAMS or Mitra) in Clinical Diagnostic hepcidin Hepcidin Determination in Dried Blood by Microfluidic LC-MS/MS: Comparison of DBS And VAMS for Matrix Effect And Recovery. proteomics | β-galactosidase, HSA, APO A-I, APO C-I, APO C-III, APO E, CRP, cystatin C, periostin Volumetric Absorptive Microsampling Integrated Into an Automated Bottom-Up Proteomics Workflow HbA1c Study 1 | Study 2 protein mix | β-lactoglobulin, myoglobin, cy- tochrome c, albumin Volumetric absorptive MicroSampling vs. other blood sam- pling materials in LC-MS-based protein analysis - prelimi- nary investigations. C-peptide Microsampling Collection Methods for Measurement of C-peptide in Whole Blood. Journal of Diabetes Science and Technology therapeutic mAbs | dalimumab, infliximab, ustekinumab, vedolizumab, tocilizumab, natali- zumab, rituximab Capillary blood microsampling to determine serum bio- pharmaceutical concentration: Mitra microsampler vs dried blood spot therapeutic mAbs | trastuzumab, daclizumab Application of Mitra® microsampling for pharmacokinetic bioanalysis of monoclonal antibodies in rats multidimensional anti-influenza IgG antibodies Application of volumetric absorptive microsampling VAMS) to measure multidimensional anti-influenza IgG antibodies by the mPlex-Flu assay apolipoproteins (apo) Early Detection of Atrial Fibrillation-Atrial Flutter Using Remote Patient Monitoring hemaglobin Prediction of haematocrit in dried blood spots from the measurement of haemoglobin using commercially avail- able sodium lauryl sulphate cardiovascular biomarkers | hsCRP, NT-proB- NP, and u-hs-cTnI A protocol integrating remote patient monitoring patient reported outcomes and cardiovascular biomarkers SARS-CoV-2 antibodies | IgG, IgM Standardization of enzyme-linked immunosorbent assays for serosurveys of the SARS-CoV-2 pandemic using clini- cal and at-home blood sampling proteomics | APOA1, APOA2, APOA4, APOB, APOC1, APOC2, APOC3, APOE, and APOJ/ CLUS, HBA, ALBU Quality Control and Outlier Detection of Targeted Mass Spectrometry Data from Multiplex Protein Panels therapeutic mAb | vedolizumab Evaluating an easy sampling method using dried blood spots to determine vedolizumab concentrations Reference The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements. analytes analyzed from Mitra ® samples The blood microsampling innovator June 2020 Edition

Transcript of roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen...

Page 1: roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit

Proteins | Peptides

peptide/proteins

Analytes

IGF-1 Study 1 | Study 2

rheumatoid factors | anti-IgM RF, anti-IgA RF, anti-CCP, anti-MCV

Volumetric Absorptive Micro Sampler (VAMS or Mitra) in Clinical Diagnostic

hepcidinHepcidin Determination in Dried Blood by Microfluidic LC-MS/MS: Comparison of DBS And VAMS for Matrix Effect And Recovery.

proteomics | β-galactosidase, HSA, APO A-I, APO C-I, APO C-III, APO E, CRP, cystatin C, periostin

Volumetric Absorptive Microsampling Integrated Into an Automated Bottom-Up Proteomics Workflow

HbA1c Study 1 | Study 2

protein mix | β-lactoglobulin, myoglobin, cy-tochrome c, albumin

Volumetric absorptive MicroSampling vs. other blood sam-pling materials in LC-MS-based protein analysis - prelimi-nary investigations.

C-peptide Microsampling Collection Methods for Measurement of C-peptide in Whole Blood. Journal of Diabetes Science and Technology

therapeutic mAbs | dalimumab, infliximab, ustekinumab, vedolizumab, tocilizumab, natali-zumab, rituximab

Capillary blood microsampling to determine serum bio-pharmaceutical concentration: Mitra microsampler vs dried blood spot

therapeutic mAbs | trastuzumab, daclizumab Application of Mitra® microsampling for pharmacokinetic bioanalysis of monoclonal antibodies in rats

multidimensional anti-influenza IgG antibodiesApplication of volumetric absorptive microsampling VAMS) to measure multidimensional anti-influenza IgG antibodies by the mPlex-Flu assay

apolipoproteins (apo) Early Detection of Atrial Fibrillation-Atrial Flutter Using Remote Patient Monitoring

hemaglobinPrediction of haematocrit in dried blood spots from the measurement of haemoglobin using commercially avail-able sodium lauryl sulphate

cardiovascular biomarkers | hsCRP, NT-proB-NP, and u-hs-cTnI

A protocol integrating remote patient monitoring patient reported outcomes and cardiovascular biomarkers

SARS-CoV-2 antibodies | IgG, IgMStandardization of enzyme-linked immunosorbent assays for serosurveys of the SARS-CoV-2 pandemic using clini-cal and at-home blood sampling

proteomics | APOA1, APOA2, APOA4, APOB, APOC1, APOC2, APOC3, APOE, and APOJ/CLUS, HBA, ALBU

Quality Control and Outlier Detection of Targeted Mass Spectrometry Data from Multiplex Protein Panels

therapeutic mAb | vedolizumab Evaluating an easy sampling method using dried blood spots to determine vedolizumab concentrations

Reference

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

analytes analyzed from Mitra® samples The blood microsampling innovator

June 2020 Edition

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Small Molecule DrugsAnalytes

therapeutic drugs

antibiotics | piperacillin, tazobactam, mero-penem, linezolid and ceftazidime

Application of Mitra Microsampling For The Quantifica-tion of Antibiotics

antibiotic | fosfomycin Quantitative Bioanalytical Validation of Fosfomycin in Human Whole Blood With VAMS

antibiotics | beta-lactams (amoxicillin, penicillin G, piperacillin, flucloxacillin, ampicillin)

Evaluation of the Mitra Device For Pharmacokinetic / Pharmacodynamic Study of Beta-Lactams

antibiotic | vancomycin, creatinine Study 1 | Study 2

antibiotic | cefepime

Development and validation of a volumetric absorptive microsampling- liquid chromatography mass spectrome-try method for the analysis of cefepime in human whole blood: Application to pediatric pharmacokinetic study

anti-cancer | hydroxyureaStable-Isotope Dilution HPLC-Electrospray Ionization Tandem Mass Spectrometry Method for Quantifying Hydroxyurea in Dried Blood Samples

anti-cancer | mitotaneA method for the minimally invasive drug monitoring of mitotane by means of volumetric absorptive microsam-pling for a home-based therapeutic drug monitoring

antidepressants | fluoxetine, norfluoxetineantidiabetic | glipzide

Evaluation of Two Blood Microsampling Approaches For Drug Discovery PK Studies in Rats

anti-depressants | venlafaxine, desvenlafaxine

Clinical validation study to derive conversion factors from capillary blood concentration to plasma concentra-tion for venlafaxine and desvenlafaxine.

anti-depressants (next gen) | sertraline, fluoxetine, citalopram and vortioxetine

Whole blood and oral fluid microsampling for the mon-itoring of patients under treatment with antidepressant drugs

antidiabetic | exenatideLarge Molecule Application of VAMS For The Determi-nation of a Single-Rodent PK Profile for Exenatide by LC-MS/MS

antifungal | itraconazoleSampling Only Ten Microliters of Whole Blood For The Quantification of Poorly Soluble Drugs: Itraconazole as Case Study

antifungal | voriconazole, voriconazole n-oxideDevelopment and validation of a volumetric absorptive microsampling assay for analysis of voriconazole and voriconazole N-oxide in human whole blood

Reference

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

analytes analyzed from Mitra® devices | page 2

Drugs of Abuse

illicit drugs

Analytes

cathinones | methylone, ethylone, butylone, mephedrone, 4-MEC, MDPV

LC-MS/MS and VAMS for quantitative bioanalysis of cathinone analogues in dried urine, plasma and oral fluid samples

cannabinoids (natural and synthetic) Dried Haematic Microsamples And LC-MS/MS for The Analysis of Natural And Synthetic Cannabinoids

opioids | oxycodone, noroxycodone, oxymor-phone

Determination of oxycodone and its major metabolites in haematic and urinary matrices: Comparison of tradi-tional and miniaturised sampling approaches

30 common drugs of abuse Quantitative Swab Touch Spray Mass Spectrometry for Oral Fluid Drug Testing

cannabinoids | THC, CBD, CBN

A patient-centric liquid chromatography-tandem mass spectrometry microsampling assay for analysis of can-nabinoids in human whole blood: Application to pediat-ric pharmacokinetic study

cocaine and metabolites Blood and Plasma Volumetric Absorptive Microsampling (VAMS) Coupled to LC-MS/MS for the Forensic Assess-ment of Cocaine Consumption

Reference

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anti-inflammatory | acetominophen Study 1 | Study 2 | Study 3

anti-inflammatory | paracetemol Study 1 | Study 2 | Study 3

anti-inflammatory | aspirinQuantitative analysis of acetylsalicylic acid in human blood using volumetric absorptive microsampling. Transl Clin Pharmacol. 2018 Mar;26(1):32-38

anti-inflammatory | naproxen Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit effect free assays

anti-parasitic | miltefosineVAMS as an Alternative to Conventional DBS Cards in The Quantification of Miltefosine in Dried Blood Sam-ples

anti-parasitic | albendazole, albendazole sulf-oxide, albendazole sulfone

Pharmacokinetics of albendazole, albendazole sulfox-ide and albendazole sulfone determined from plasma, blood, dried blood spots and Mitra® samples of hook-worm-infected adolescents

anti-rheumatic | hydroxychloroquine Capillary Blood Collected on VAMS Device For Monitor-ing Hydroxychloroquine in Rheumatoid Arthritis Patients

visual cycle modulators | emixustat Bioanalysis of emixustat in whole blood collected with VAMS by LC-MS/MS

cardiovascular drugs | amlodipine, atenolol, atorvastatin, bisoprolol, diltiazem, lisinopril, losartan, ramipril, simvastatin, valsartan

Volumetric absorptive microsampling (VAMS) coupled with high-resolution, accurate-mass (HRAM) mass spectrometry as a simplified alternative to dried blood spot (DBS) analysis for therapeutic drug monitoring of cardiovascular drugs

stimulants | paraxanthineDoes Volumetric Absorptive Microsampling Eliminate The Hematocrit Bias for Caffeine And Paraxanthine in Dried Blood Samples? A Comparative Study

sedative | midazolam, phenobarbital Supporting a paediatric study using wet and dry sam-ples Analytical Considerations

GSKA | proprietary small molecule drug cur-rently under clinical development

Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects

antidiabetic | sitagliptin

Extractability-mediated stability bias and hematocrit im-pact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulat-ed bioanalysis

antiretroviral | raltegravir

Extractability-mediated stability bias and hematocrit im-pact: High extraction recovery is critical to feasibility ofvolumetric adsorptive microsampling (VAMS) in regulat-ed bioanalysis.

antiretroviral | ritonavir Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit effect free assays

antihelmintics | praziquantel

Evaluation of a novel micro-sampling device, Mitra™, in comparison to dried blood spots, for analysis of praziquan-tel in Schistosoma haematobium-infected children in rural Côte d’Ivoire

bronchodilator | salbutamolQuantitation of salbutamol using micro-volume blood sampling – applications to exacerbations of pediatric asthma

antisetics | amisulpride, aripiprazole, clozap-ine, olanzapine, quetiapine, risperidone, ziprasidone

TDM by Means of Novel Sampling (VAMS) And Ex-traction Procedures - A Comparative Study

anti-seizure | radiprodilA pharmacokinetic study of radiprodil oral suspension in healthy adults comparing conventional venous blood sampling with two microsampling techniques

anti-epileptics Study 1 | Study 2 | Study 3 | Study 4 | Study 5 | Study 6

Small Molecule Drugs continued

ReferenceAnalytes

analytes analyzed from Mitra® devices | page 3

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

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methotrexate polyglutamateTransition of Methotrexate Polyglutamate Drug Monitoring Assay from Venipuncture to Capillary Blood-Based Collec-tion Method in Rheumatic Diseases

infliximab (IFX)Dried blood samples can support monitoring of infliximab concentrations in patients with inflammatory bowel dis-ease: A clinical validation

gamma-hydroxybutyric acid(GHB)Development and validation of volumetric absorptive mi-crosampling coupled with UHPLC–MS/MS for the analysis of gamma‐hydroxybutyric acid in human blood

midazolamValidation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsa-mpling

phenobarbital

Dried blood microsampling-based therapeutic drug monitoring of anti-epileptic drugs in children with nodding syndrome and epilepsy in Uganda and the Democratic Republic of the Congo.

Small Molecule Drugs continued

ReferenceAnalytes

analytes analyzed from Mitra® devices | page 4

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

Hormones | Steroids

Analytes

estetrolWhole Blood Microsampling For The Quantitation of Estetrol Without Derivatization by Liquid Chromatography-Tandem Mass Spectrometry

cortisol & testosterone

Measurement of Cortisol and Testosterone in Athletes: Accuracy of Liquid Chromatography-Tandem Mass Spectrometry Assays for Cortisol and Testosterone Measurement in Whole-Blood Microspecimens

anabolic steroids | testosterone, epites-tosterone, dihydrotestosterone, nandrolone, norethandrolone, androstenedione, mester-olone, methandrostenolone, danazol

Overcoming Biosampling Issues in Sport Drug Testing

estrogens

Comparison of nanofluidic and ultra-high performance liquid chromatography-tandem mass spectrometry for high sensitive pharmacokinetic studies of estrogens starting from whole blood microsampling

testosterone Androstenedione & 17-Hydroxy-progesterone

Quantification of Testosterone, Androstenedione and 17-Hydroxyprogesterone Collected Using Mitra®Micro Sampling Devices

corticosterone, dehydrocorticosterone progesterone

Influence of Low Protein Diet-Induced Fetal Growth Re-striction on the Neuroplacental Corticosterone Axis in the Rat

glucocorticoids | cortisol, corticosterone, cor-tisone, dexamethasone, methylprednisolone, fludrocortisone

Microsampling and LC–MS/MS for antidoping testing of glucocorticoids in urine

growth hormone doping biomarker | IGF-1 Use of capillary dried blood for quantification of intact IGF-I by LC–HRMS for antidoping analysis

Reference

Page 5: roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit

analytes analyzed from Mitra® devices | page 5

Metabolomics & Metabolism

Metabolomics

Lactones

Esters

Lipid-Derived

Long-chain aldehydes

Phenolic volatiles

Analytes

breast cancer metabolites Comparative study on microsampling techniques in metabolic fingerprinting studies applying gas chroma-tography-MS analysis.

polar blood metabolome Pre-analytic evaluation of volumetric absorptive micro-sampling and integration in a mass spectrometry-based metabolomics workflow

urinary metabolites Evaluation of the Mitra microsampling device for use with key urinary metabolites in patients with Alkaptonuria)

amino acids, organic acids Targeted metabolomics of whole blood using volumetric absorptive microsampling

Iohexol as a GFR for chronic kidney disease Determination of iohexol by capillary blood microsampling and UHPLC-MS/MS

collecting metabolomic fluids w/ VAMS® (mini review)

Biofluid Collection in Metabolomics by the Application of the novel Volumetric Absorptive Microsampling Technolo-gy: a mini-Review

palmitate, stearate Quantitating fatty acids in dried blood spots on a common collection card versus a novel wicking sampling device

Reference

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

Metals

metals

Analytes

biomarker | FeIron isotopic analysis of finger-prick and venous blood

by multi-collector inductively coupled plasma-mass spectrometry after volumetric absorptive microsampling

multi-element analysis Analysis of Whole Blood by ICP-MS Equipped With a High Temperature Total Sample Consumption System

prosthesis-related metals | Co, Cr, Al, Ti, V, Ni, Sr, Zr Study 1 | Study 2

elemental clinical analysis Dried matrix spots and clinical elemental analysis. Cur-rent status, difficulties, and opportunities

cobalt - metal-on-metal prosthesis

Development, validation and application of an inductively coupled plasma – Mass spectrometry method to deter-mine cobalt in metal-on-metal prosthesis patients using volumetric absorptive microsampling

mercury (Hg)

A simple and direct atomic absorption spectrometry meth-od for the direct determination of Hg in dried blood spots and dried urine spots prepared using various microsam-pling devices

Reference

DNA / RNA

dna/rna

Analytes

miRNA library, SNPs, qPCRTotal RNA/DNA Purification And Detection FromBlood Preserved on a Mitra® Microsampling Device

circulating RNA, NGS NGS analysis of total small non coding RNAs from low input RNA from dried blood sampling

small noncoding RNAs | miRNA, snoRNA, YRNA, tRNA

The sncRNA Zoo: a repository for circulating small non-coding RNAs in animals

Reference

Page 6: roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit

analytes analyzed from Mitra® devices | page 6

Immunosuppressants

immunosuppressants

Analytes

methotrexateVolumetric Absorptive Micro Sampler(VAMS or Mitra) in Clinical Diagnostic

cyclosporin A, tacrolimus, ascomycin, sirolim-us, everolimus, temsirolimus Study 1 | Study 2

tacrolimus Study 1 | Study 2 | Study 3 | Study 4 | Study 5

cyclosporine A, everolimus, sirolimus, and tac-rolimus

Feasibility of Immunosuppressant Drug Monitoring by a Microsampling Device

everolimusValidation and clinical application of an LC-MS/MS meth-od for the quantification of everolimus using volumetric absorptive microsampling

cyclosporine A, tacrolimus

Volumetric Microsampling of Capillary Blood Spot vs Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus and Cyclosporin A: Accuracy and Patient Satisfaction

mycophenolic acid, tacrolimus, sirolimus, everolimus, cyclosporin A

VAMS for Assaying Immunosuppressants from Venous Whole Blood by LC-MS/MS Using a Novel Atmospheric Pressure Ionization Probe (Unispray™)

adalimumabMonitoring of Adalimumab Concentrations at Home in Patients with Inflammatory Bowel Disease Using Dried Blood Samples

Reference

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.

Cytotoxins

cytotoxins

Analytes

sulfur mustard albumin adductsProcedures For Analysis of Dried Plasma Using Micro-sampling Devices to Detect Sulfur Mustard-Albumin Adducts For Verification of Poisoning

saxitoxin Quantification of Saxitoxin in Human Blood by ELISA

Reference

Vitamins / Supplements

supplements

Analyte

biomarker | 25-hydroxy vitamin D3Study 1 | Study 2

5-Methyltetrahydrofolic Acid (Folate)

Assessing VAMS Coupled with Stable Isotope Dilution Assay and Liquid Chromatography-Tandem Mass Spec-trometry as Potential Diagnostic Tool for Whole Blood 5-Methyltetrahydrofolic Acid

vitamin D metabolitesComparing Diene Derivatisation Methods of Dry Blood Samples For Vitamin D Metabolites Quantification by Liq-uid Chromatography-tandem Mass Spectrometry.

Reference

Page 7: roteins eptides - Neoteryx · Clin Pharmacol. 2018 Mar;26(1):32-38 anti-inflammatory | naproxen Volumetric absorptive microsampling combined with im-pact-assisted extraction for hematocrit

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The blood microsampling innovator

The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is designed to be used by laboratory and healthcare profession-als, or end-users as a container to collect and transport blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Device in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements. The Mitra Device is a FDA listed Class 1 exempt device, CE-IVD self-certified in the UK and EU, a Class I IVD in Australia, and registered with Health Canada. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485. Copyright © 2020 Neoteryx, LLC. All rights reserved.

neoteryx.com/freesampler

analytes analyzed from Mitra® devices | page 7

VAMS™ Technology Reviews

Metabolomics

Lactones

Esters

Lipid-Derived

Long-chain aldehydes

Phenolic volatiles

Keywords

sampling, drying, transportation, extraction Study 1 | Study 2 | Study 3

point-of-care device, minimally invasive Study 1 | Study 2

Reference