PRA Health Sciences
Global Bioanalytical Services
Early Development Services
Amerikaweg 18
9407 TK Assen
The Netherlands
PRA Health Sciences
Clinical Laboratory
Early Development Services
Van Swietenlaan 6
9728 NZ Groningen
The Netherlands
PRA Health Sciences
Global Bioanalytical Services
Early Development Services
10836 Strang Line Road
Lenexa, KS 66221
USA
Bioanalysis, Biomarker and Flow Cytometry Assay List
PRA Laboratories
Solutions for Drug Development
Behind every sample waiting to be analyzed,
there is a patient waiting to be cured.
GLP–Compliant Bioanalytical Laboratories
PRA maintains two modern bioanalytical laboratories in Lenexa, Kansas, USA and Assen, Netherlands. Their strategic
locations near our early phase Clinical Research Units (CRUs) allow time-critical and limited stability samples to be
analyzed quickly. The laboratories both conduct bioanalysis of small molecules, biologics and biomarkers for pre-clinical
and Phase I-IV human clinical studies. They are fully harmonized operations and adhere to the same stringent global
regulatory guidelines including GLP compliance.
These facilities provide the ideal environment for complex bioanalytical services, including standalone projects, those
combined with an early phase trials in one of PRA’s CRUs, and those conducted in conjunction with PRA’s Product
Registration Services division. Both laboratories are equipped with the latest technologies and infrastructure, as
required by pharmaceutical and biotechnology companies.
Our bioanalytical laboratory services include:
• Pharmacokinetic bioanalysis of small molecules and biologics
• Immunogenicity analysis and cell-based neutralizing antibody measurements (Nab)
• Biomarker Analysis
• Flow Cytometry Analysis
• Biochemistry (stimulation assays, enzymatic activity)
• GMP Quality Control
• Radioisotope Analysis
• Global Supply Logistics
• Biomarker Strategic Consultation
Utilizing the following technologies and facilities:
• Sciex LC/MS/MS, Agilent and Waters UPLC systems.
• ELISA, MSD ECLIA, EMD Singulex Erenna, ProteinSimple ELLA.
• FACSCanto 8 Color, Fortessa 18 Color Flow Cytometers and Glomax Luminescence plate reader.
• Hamilton and Tomtec Robotic Automation.
• Radioisotope analysis laboratory, with a permanent license for the analysis of radiolabeled compounds (14C, 3H).
• Biohazard laboratory with a Biosafety Level II license (microbiological laboratory Class II [ML-II]), qualified to
handle potentially infected samples.
• Co-located Phase 1 Clinics at both laboratories.
Full-Service Clinical Laboratory
PRA also offers clinical chemistry services in a fully equipped, dedicated laboratory. Our clinical laboratory has
supported more than 3000 clinical studies over 30 years, and can typically report data within 8 hours after sample
receipt. For immediate safety analysis, turnaround times of 1 hour are feasible. All analyzers are bi-directionally linked
with an intelligent laboratory information system, enabling fully automated, barcode-driven analysis and reporting of
results.
Our Clinical Laboratory services include:
• Hematology, including automated differentiation
• Coagulation parameters
• Immunology, using both fully automated analyzers and semi-automated ELISA equipment
• Urinalysis, fully automated for screening and microscopy analysis
• Capabilities of LPS Challenge stimulation, PBMC-isolation techniques and Platelet Aggregation analysis
PRAH£ALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays
[R]- and [S]-Ketamine Adrenaline
[R]- and [S]-Ketamine and Norketamine Adrenocorticotropic hormone (ACTH)
[R]- and [S]-Mephenytoin Aldosterone
[R]- and [S]-Methadone Aldosterone and 11-deoxy corticosterone
[R]- and [S]-Omeprazole Alitretinoin
[R]-Warfarin Alkaline phosphatase
2'5’ Oligoadenylate synthetase (OAS) Alprazolam
3-O-Methyldopa Ambasilide
3,4-Dihydroxyphenylacetic acid (DOPAC) and Amitriptyline
homovanillic acid (HVA) Amlodipine
3,4-Dihydroxyphenylglycol (DHPG) Amoxicillin
311C90 (Zolmitriptan) Amyloid β (ABeta) 42
3H low level Angiopeptin 1 (ANG1)
3H Radioactivity Angiopeptin 2 (ANG2)
3H-Isotretinoin Anti-alkaline phosphatase antibodies
4-Hydroxymephenytoin Anti-amyloid β 1-28 Abs
4β-Hydroxycholesterol Anti-Bevacizumab
4-methyl benzoic acid (MBzA) Anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
5-α-Dihydrotestosterone (DHT) Anti-HBsAG
5-Azacytidine Anti-IFNα
5-Fluorouracil Anti-il20
5-Hydroxypiroxicam Anti-IL21
6ß-Hydroxycortisol Anti-Müllerian hormone (AMH)
6-OH-Norketamine Anti-Natalizumab antibodies
7-Acetamido-clonazepam Anti-PEG antibodies
7-α-(thiomethyl) Spironolactone Anti-Pembrolizumab
11-Dehydro Thromboxane B2 Anti-relaxin2
11-Deoxycortisol Anti-Tissue Factor Pathway Inhibitor (TFPI)
13C Radioactivity Anti-Trastuzumab Neutralizing Antibodies
14C Radioactivity Antipyrine
17-α-Hydroxyprogesterone Apolipoprotein B100
17-α-Hydroxyprogesterone Caproate Apolipoprotein B48
25-Hydroxy vitamin D Apomorphine
α-1-antitrypsin/ Neutrophil Elastase complex Aquaporin 2 (AQP2)
α-Glucosidase Aranesp
α-Glutathione-S-transferase (GST) Arimoclomol
α-Synuclein bound and free Aripiprazole + Dehydroaripiprazole
α-thrombin Arteether
Abacavir Artemether and dihydroartemisinin
Abiraterone and Abiraterone acetate Artesunate (ARTS) and Dihydroartemisinin (DHA)
Acenocoumarol Ascorbic Acid
Acitretin Asymmetric Dimethylarginine (ADMA)/arginine
Active Renin Asenapine + desmethyl asenapine
Adalimumab List Adiponectin continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Atazanavir Carbamazepine
Atorvastatin (also known metabolites) Carbidopa
Azapropazone Cedazuridine and epimer
Azatadine Cefepime
azatadine Ceruloplasmin
ß2-Microglobuline Cetrorelix
B-cell activating factor (BAFF) Chlorpheniramine
Bendamustine Chlorthalidone
Bendamustine, M3 and M4 Metabolite Cholecystokinin (CCK)
Benzylpenicillin Chromium-51
Bevacizumab Cimetidine
Bone-specific alkaline phosphatase (BAP) Cinnarizine
Bortezomib Circulating Tissue Factor
Brain-Derived Neurotrophic Factor (BDNF) Cisapride
Brivaracetam and metabolites Clarithromycin
Brompheniramine Clofazimine
Budesonide Clofibric acid
Bumetanide Clomipramine
Buprenorphine and Norbuprenorphine Clonazepam
Bupropion and OH-bupropion Clonidine
Buspirone Clopidogrel active metabolite
C-terminal telopeptide type 1 (CTX-1) Clopidogrel and clopidogrel carboxylic acid
C-terminal telopeptide type 2 (CTX-2) Cloprednol
C-Peptide Clotrimazole
C-terminal telopeptide (CTX) Copeptin (CPP)
Complement C3 (C3) Corticosterone
Complement C3 alpha des arg (C3a des arg) Cortisol
Complement C4 (C4) Cortisol and 6-βhydroxyl cortisol
Complement C4 7α-hydroxy-4-cholesten-3-one (C4) Creatinine
Complement C5 (C5) Cromoglycate
Complement C5 alpha des arg (C5a des arg) Cromolyn Disodium Salt
Cabazitaxel Culture of HELA cells
Cabozantinib Cyanocobalamin
Caffeine Cyclic guanosine monophosphate (cGMP)
Caffeine metabolite AAMU Cyclosporine
Caffeine and Paraxanthine Cyclosporine A
Candesartan Cyclosporine and tacrolimus
Cannabidiol (CBD) CYP2C9
Cannabidiol, 7-OH-CBD, 7-COOH-CBD Cyproterone acetate
Cannabidivarin (CBDV) Cytarabine
Cannabidivarin deriviatives: 6-OH-CBDV, 7-OH-CBDV Cytokines (Multiplex Assays)
and 7-COOH-CBDV Dacarbazine and 5-aminoimidazole-4-carboxamide
Canrenone Dacarbazine and AIC
Capecitabin List Captopril (total) continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Darbepoetin alfa (Aranesp) Enalaprilate
Dapagliflozin Endothelin
Dapiverine and miconazole Epirubicin
Dapivirine Epirubicinol
Daunorubicine (also known metabolites) Erlotinib
Decitabine Erythromycin + N-desmethyl erythromycin
Desacyl-ghrelin Erythropoietin (EPO)
Detomidine Esomeprazole
Detomidine, 3-carboxy detomidine Estetrol (E4)
Dehydroepiandrosterone (DHEA) Estradiol
Dehydroepiandrosterone sulfate (DHEA-S) Ethambutol
Desogestrel Ethanol
Deulevodopa Ethinylestradiol
Dexamethasone Ethionamide
Dexmedetomidine Etoposide
Dextromethorphan and dextrorphan Everninomicin
Dextromethorphan, Dextrorphan Exemestane
Dextromoramide Exenatide
Dihydroxyphenylglycol (DHPG) Exendin-4
Diazepam Fatty Acid-Binding Protein 4 (FABP4)
Diclofenac Factor anti-lla
Digoxin Factor anti-Xa
Dihydroartemisinic (DHA) Factor P
Dehydronorketamine Factor VIIa
Diltiazem Felbamate
Dilute Prothrombin time Fentanyl
Dipeptidyl Peptidase IV activity (DPP-4) Ferritine
DNA Isolation Fexafenodine
Docetaxel Fibroblast growth factor 21 (FGF-21)
Dofetilide Flubendazole
Dolastatin 10 Flubendazole metabolites
Domperidone Fluconazole
Donepezil, 5-O- and 6-O-Desmethyl Donepezil Flupirtine, D13223 and 4-fluorohippuric
Dopamine, 3MT, deudopamine, deu-3MT Flurbiprofen and OH-Flurbiprofen
Doxapram and Keto-doxapram Fluvastatin
Doxepin Formoterol
Doxorubicin Free Desmosine
Doxorubicinol Free IL-21
Drospirenone Free PTH (1-34) and Free PTH(1-33)
E-Selectin Follicle-stimulating hormone (FSH)
Eosinophil derived neurotoxin (EDN) Granulocyte colony-stimulating factor (G-CSF)
Efavirenz Guanidinoacetic acid (GAA)
Elastase-1 Gabapentin
Emtricitabine List Enalapril continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Galantamine Iohexol
Ganciclovir Irinotecan, SN-38 and SN-38-glucuronide,
Growth arrest-specific 6 (GAS6) Isepamicin
Gemfibrozil Isoniazid and pyrazinamide
Gentamicin Isotretinoin
Glial growth factor (GGF2) insulin
Glucose-Dependent Insulinotropic Polypeptide (GIP) Intercellular adhesion molecule (ICAM)
Glibenclamide Intestinal-type Fatty Acid Binding Protein (I-FABP)
Glimepiride and 5-OH-glimepiride Itraconazole and 2-OH-Itraconazole
Glucagon Jo-1, polyclonal antibody
Glucagon-like peptide-1 (GLP1) total and active Kanamycine
Glucagon-like peptide-2 (GLP-2) Ketamine
Glucaric acid Ketoconazole
Glucose Kidney Injury Molecule-1 (KIM-1)
Glutamine synthetase L-Dopa
Glutathione S-transferase Pi (GST-Pi) Lamotrigine
Glyburide Lamivudine
Granulocyte-macrophage colony-stimulating factor Lanosterol, Sitosterol
(GM-CSF) Leptin (Human)
Haloperidol Leukotriene B4 and E4
Heart-type Fatty Acid Binding Protein (H-FABP) (Very) Low Density Lipoprotein (LDL/VLDL)
Helicobacter pylori levetiracetam
Heparan Disaccharides Levonorgestrel
Herceptin Levodopa
High Density Lipoprotein (HDL) Luteinizing hormone (LH)
Human chorionic gonadotropin (hCG) Lidocaine
Human growth hormone (hGH) Lopinavir, darunavir and ritonavir
Human vegF-A Lorazepam
Hydoxypropyl-ß-cyclodextrin Losartan
Hydrochlorothiazide Lovastatin
Hydrocodone and Acetaminophen Loxoprofen + 2 metabolites
Hydrocodone and Hydromorphone LPS Challenge test
hydroxypropyl-β-cyclodextrine LPS/PGE2 stimulation
Ibuprofen Lumefantrine
Idazoxan Mannose Associated Serine Protease 2 (MASP-2)
Idarubicin and Idarubicinol Macrophage colony-stimulating factor 1 (CSF-1)
Idebenone Matrix metalloproteinase-1 (MMP-1; total)
IgG Monoamine Oxidase B (MAO-B) activity
IgG anti-p17 Megestrol acetate
Inactivated complement 3b (iC3b) Melatonin
Indinavir Melperone
indocyanine green Memantine
Inhibin B Metformin
Insulin List Insuline like growth factor (IGF-1) continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Methadone Octreotide
Methotrexate + 7-OH-methotrexaet Odalasvir
Methylphenidate Ofloxacin
Methylthioninium (free and conjugated) Olanzapine
Methylthioninium and Omeprazole and 5-hydroxyomeprazole
desmethyl methylthioninium Ondansetron
Metoprolol and α-hydroxymetoprolol Oseltamivir, Oseltamivir Carboxylate
Metronidazole Osteocalcin
Miconazole Osteopontin (OPN)
Midazolam and 1OH-Midazolam Oxazepam
Mirtazapine Oxycodone, noroxycodone, acetaminophen
Mitoxantrone Oxytocin
Moclobemide p-Aminohippuric acid (PAH)
Mometasone p-Hydroxy-phenobarbital (total)
Monocyte Chemotactic Protein-1 (MCP-1)/IP-10 P-Selectin
Monohydroxycarbamazepine Paclitaxel
Monomethyl auristatin E (MMAE) Paliperidone and paliperidone palmitate
Monomethoxypoly(ethylene glycol) mPEG Paliperidone enantiomers
Morphine Palonosetron
Motilin Pancreatic polypeptide (PP)
Moxifloxacin Paracetamol and metabolites
Naproxen Parathyroid hormone (PTH) / PTH Total
Natalizumab Paroxetine
Nefopam Pegylated Granulocyte Colony Stimulating Factor
Nelfinavir and Nelfinavir-M8 (PEG-G-CSF)
Neopterin Pembrolizumab
Neutrophil Elastase Pemetrexed
Neurofilament Light (NF-L) Peptide tyrosine tyrosine (PYY)
Neutralizing anti-FA relaxin antibodies Phenobarbital (total)
Neutrophil gelatinase-associated lipocalin (NGAL) Phenytoin
Nevirapine Phosphorylated tau (pTau)
Nerve Growth Factor (NGF) Pilocarpine
Nicotinamide adenine dinucleotide (NAD+) Pimozide
Nicotine Metabolites Pindolol
Nifedipine Pioglitazone
Niraparib Pioglitazone and rosiglitazone
Nitrazepam Pioglitazone metabolites MIII and MIV
Noradrenaline Piroxicam
Norethindrone Plasminogen activator inhibitor-1 (PAI-1)
Norgestrel Polyethylene glycol (PEG)
Norketamine Ponesimod
Nortriptyline Pravastatin
N-telopeptide of type I collagen (NTX-I) Pre-Albumin
N-terminal pro b-type natriuretic peptide List (NT-proBNP) continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Prednisolone Risperidone and 9-Hydroxyrisperidone
Pregnenolone sulphate Risperidone and Paliperidone
Pretomanid (PA-824) Ristocetin cofactor (RICO)
Primidone Ritonavir
Pro-atrial natriuretic peptide (pro-ANP) Rivastigmine
proANP (1-98) Rosiglitazone and desmethylrosilitazone
Probenecid Rosuvastatin and 2 metabolites
Procollagen C-terminal peptides (PICP) Rotigotine
Procollagen I N-terminal peptides (PINP) S-citalopram
Progesterone, allopregnenolone, pregnanolone S-ketamine
pro-hepcidine Salbutamol
Prolactin Salicylic acid and Acetyl Salicylic acid
Propafenone Saquinavir
Proprotein convertase subtilisin/kexin type 9 sCD40L
(PCSK9) Scopolamine
Prostaglandine E2 sE-selectin + sP-selectin
Prothrombin Fragment F1 + F2 Selexipag
Pseudoephedrine Serum Amyloid A (SAA)
Pyrazinamide Serum surfactant protein D (SP-D)
Rabeprazole Sex hormone binding globulin (SHBG)
Radiprodil and metabolites sICAM + sVCAM
Raltegravir sIL-6R
Ranitidine Simvastatin and simvastatin acid
Rat C-peptide Simvastatin-derived HMG-CoA reductase inhibitors
Receptor Activitor for Nuclear Factor B (RANK) simvastatin+ metabolite
Recombinant follicle stimulating hormone (rFSH) Sirolimus
Recombinant human α-galactosidase A Sitagliptin
(rh-alpha-Gal A) Soluble BCMA (sBCMA), Free/Total
Recombinant human Growth Hormone (rhGH) soluble CD25/IL-2Rα
Recombinant human Lactoferrin (rhLF) soluble CD62L
Red Blood Cell (RBC) lysis Soluble Transferrin Receptor
Regulated on Activation, Normal T Cell Expressed Soluble tumor necrosis factor receptor type 1 (sTNF-R1)
and Secreted (RANTES) Soluble tumor necrosis factor receptor type 2 (sTNF-R2)
Regorafenib, M2 + M5 Sorafenib
Relaxin 2 Sorivudine
Renin activity Spironolactone
Renin concentration Sufentanil
Repirinast metabolite Bay w 8199 Sulfapyridine
Retinol-binding protein 4 (RBP4) Sulindac
Rheumatoid factor (RF) Sulphamethoxazole
Ribavirine Sulpiride
Rifabutin and 25-O-Desacetylrifabutin Sumatriptan
Rifampicin and 25-desacetyl rifampicin Suvorexant
Rifapentine and 25-desacetyl-rifapentine List Rimantadine continues on next page ⇒
~~ PRAHEALTHSCIENCES
PRA laboratories have experience with all assays listed above. Some of these assays, however may be validated at a single laboratory
location or otherwise not be fully validated up to current standards. In those cases, assays might need some additional validation efforts.
PRA is open to discussing absorbing the costs related to the additional experiments and ownership for the methods. Please contact us for
detailed information on the assays and their status.
Version: Q3 2019
Bioanalytical Assays (continued)
Trastuzumab emtansine (catabolites) Total cholesterol
Tamiflu Total desmosine and isodesmosine
Tamoxifen Total Dopamine
Tapentadol and tapentadol glucuronide Total IgE
Tasquinimod Total IL-21
Temsirolimus Total PEG
Tenofovir and Adefovir Transforming growth factor β1 (TFG-β1)
Terbutaline Total sitosterol
Teriflunomide Total Tau
Testosterone Total proanthocyanidins contents (TPAC)
Tetrahydrocannabinol (THC) and metabolites Terephthalaldehyde (TPAL)
Thalidomide Trabectin
Theophylline Tramadol (+/-) and its matabolites (+/-)
Thiamine Trastuzumab
Thiobarbitoric acid reactive substances (TBARs) Trazodone
Thrombin-antithrombin complex (TAT) Tretinoin
Thrombin generation Triazolam
Thymus and activation-regulated chemokine Trimethoprim
(TARC) Troglitazone
Thyroid stimulating hormone (TSH) Tromboxane B2
Thyroxine (T4) Tyramine
Thyroxine binding globulin (TBG) Tysabri
Tianeptine Ubiquinone
Tiludronate Urotensin II
Timolol Urotensin Related Peptide (URP)
Tirofiban Vaccine antibody titer
Tocilizumab Valpatasvir
Tofisopam vascular cell adhesion molecule 1 (VCAM-1 CD106)
Tolbutamide, 4-hydroxytolbutamide and Vascular endothelial growth factor (VEGF)
carboxytolbutamide VegF soluble receptor 2
Tolterodine and 5-hydroxymethyl tolterodine von Willebrand factor (VwF)
Tonabersat and SB-277726 Zinc Protoporphyrin
Topotecan
~~ PRAHEALTHSCIENCES
Version: Q3 2019
Flow Cytometry Lab Assays
Short description Markers
Immune Phenotyping - basic
T cells (CD4 and CD8) immunophenotyping CD45,CD3,CD4,CD8
T, B, and NK cell immunophenotyping CD45,CD3,CD19,CD16,CD56
Monocytes and granulocytes immunophenotyping CD45,CD14,CD16
B-cell Immunophenotyping using Trucount CD3,CD5,CD20,CD45
CD34+ leukocytes in human whole blood CD45,CD34
T, B, NK, neutrophils and monocytes immunophenotyping (numbers and
percentage)
CD3,CD4,CD8,CD45 + CD3,CD45,CD19,CD16,56 + CD45,CD16,CD14
Leukocyte subsets in human whole blood CD3,CD4,CD8,CD45RA,CD45RO,CD45 + CD20,CD83,CD16,CD56,CD3,CD45
CD16 expression on monocytes (subset identification and enumeration) CD45,HLA-DR,CD16,CD14
CD4+,CD25+,FOXP3+ regulatory T-cells CD4,CD25,FoxP3
distribution of various T cell subsets CD4,CD134,CD25,CD8,CD3,CD45RO,CD56,CD16
CD25+ blasts whole blood and bone marrow CD25,CD34,viability
CD25+ blasts and target receptors, whole blood and bone marrow CD25,CD34,CD99,CD123,viability + CD25,CD34,CD122,CD132,viability
CD19 and associated receptors in whole blood and bone marrow CD20,CD79b,CD19,CD22,CD45,CD21
CD10 positive B-cells CD45,CD3,CD19,CD20,CD10
Fetal hemoglobin (HbF) expression on Red blood cells CD345a,7-AAD,HbF
Immune Phenotyping - deep
PD-1 and CTLA-4 on B-cells, T-cells and monocyte subsets CD4,CD8,CD19,CTLA-4,CD25,PD-1,CD69,CD45RO +
CD11b,CD83,CD11c,CD14,CD16,CD80,HLA-DR,CD40
PD-1 in leukocyte subsets T-, B- and NK-cells (CD4,CD8 T-cells, naïve and
memory B- and T-cells)
CD3,CD4,CD8,CD45RO,CD19,CD27,CD16,CD56,PD-1
CTLA4+ Tregs in whole blood CD4,CD25,FoxP3,CD152
Deep T-cell phenotyping CD3,CD4,CD8,CD185,CD279,CD278,CD45RA,CD57 ,
CD3,CD4,CD8,CD197,CD45RO,CD95,CD69,CD28 ,
CD3,CD4,CD8,CCR4,CCR6,CXCR3,HLA-DR,CD154
B-cells, dendritic cells and IFN regulated genes CD19,IgD,CD27,CD38,CD24,CD95,CD86,CD21 ,
CD83,CD40,CD80,CD303,CD86,HLA-DR,CD1c,Lin1 ,
CD19,IgD,CD27,CD38,CD14,CD16,CD169,CD64
T, B, NK cells and CD14 monocytes in cryopreserved PBMC samples CD3,CD45,CD4,CD8,CD19,CD16+56,CD14,viability
List continues on next page ⇒
PRAHEALTHSCIENCES
Version: Q3 2019
Flow Cytometry Lab Assays (continued)
Short description Markers
Immune Phenotyping – deep (continued)
Extensive T-cell phenotyping CD3,CD4,CD8,CD185,CD279,CD278,CD45RA,CD57 /
CD3,CD4,CD8,CD197,CD45RO,CD95,CD69,CD28 /
CD3,CD4,CD8,CCR4,CCR6,CXCR3,HLA-DR,CD154
B-cells, dendritic cells and IFN regulated genes CD19,IgD,CD27,CD38,CD24,CD95,CD86,CD21 /
CD83,CD40,CD80,CD303,CD86,HLA-DR,CD1c,Lin1 /
CD19,IgD,CD27,CD38,CD14,CD16,CD169,CD64
2 panel extended T-cell phenotyping CD57,CD279,CD278,CD45RA,CD185(CXCR5),CD8,CD3,CD4 / CD8,CD194
CCR4,CD196 (CCR6),HLA-DR,CD154+CD3,CD4,CD183 (CXCR3)
Multiple markers for T-cells CD3,HLA-DR,CD45RA,CCR4 (CD194),CD4,CXCR3 (CD183),CD127,CCR6
(CD196),CCR7 (CD197),CD25,CD45RO,CD8,CD38
Multiple markers for B-cells CD19,IgD,CD38,CD20,CD24,CD34,CD21,IgM,CD138,CD10,CD27,CD45 and
Lineage- (=CD3,CD14)
Th1, Th2, Th17 & Th22 T cell subsets CD45,CD3,CD4,CCR6,CCR4,CXCR3,CCR10,CD69
Dendritic cells Lin1-,CD80,CD1c,CD83,HLA-DR,CD40,CD303(BDCA2),CD86
B and NK cell immunophenotype CD19,CD27,CD38,CD138,CD56,CD24,CD45
T cell immunophenotype CD25,CD8,CD279 (PD-1) CXCR5,CD127,CD3,ICOS,CD4
Determination of a receptor on the cell surface of monocytes, DCs, B cells CD45,CD19,CD14 ,CD32,CD64 ,CD16 ,CD3,CD56,CD11c,CD123,HLA-DR
Regulatory T cell function – Panel 1 CD25,CD39,CD3,FOXP3,CD45,CD4,HELIOS,CTLA-4
Regulatory T cell function – Panel 2 CD25,CD3,CD278 (ICOS),OX40,FOXP3,CD4,CD279 (PD-1),CD45
Activation markers
CD63 activation in basophils after FCeR1 stimulation; flow CAST kit CCR3,CD63
CD63 activation in basophils after IL-3 and IgE stimulation (not Flow CAST kit) CD63,CCR3
MHC-II on B cells and monocytes CD45,CD19,CD14,MHC-II
phosphorylated proteins in PBMC CD20,CD45,CD14,CD3,pospho proteins pBTK, pPLCg, pERK
Stimulation of B-cells for phospho proteins CD20,CD3,pSyk,pBTK,pERK
Inhibitory effects of HDAC inhibitor on acetylation CD3,acetylated α tubulin,acetylated histone,monocytes
Inhibitory effects of HDAC inhibitor on total protein CD3,total α tubulin,total histone,monocytes
pSTAT5 and pSTAT2 assay CD3,CD45,pSTAT2,pSTAT5
ligand Induced CD69 expression CD69,CD19,viability
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PRAHEALTHSCIENCES
Version: Q3 2019
Flow Cytometry Lab Assays (continued)
Short description Markers
Activation markers (continued)
CCL3,CCL4 levels CCL3,CCL4
ligand induced CD319 expression in monocytes CD319,CD14,viability
T-cell proliferation after PHA stimulation or compound stimulation CD3,CD45,EdU,viability
pSTAT5 activation in regulatory T cells CD25,CD8,CD3,FOXP3,CD45,CD4pPSTAT5
Regulatory T cell proliferation CD45,CD3,CD4,CD8,CD16,CD56,CD25,FOXP3,Ki67
S6 , Akt in human whole blood anti-S6,anti-Akt
pCREB levels CD8α,CD14,pCREB
Phenotype B, T and NK cell + CD69 CD45,CD3,CD4,CD8,CD16,CD19,CD69
CD18, CD11b, CD62 and CD45 expression on granulocytes (combi with
stimulation)
CD18,CD11b,CD62L,CD45
pAKT in human B-lymphocytes from PBMCs pAkt(Ser),pAkt (Thr308),S6(Ser235,236),CD19
Cell-cycle determination,cell proliferation (determination of DNA synthesis) CD3,CD45,EdU
pSTAT5 in human whole blood on T-cells and granulocytes pSTAT5
S6 , Akt in human whole blood anti-S6 , anti-Akt
S6 , Akt CD20,S6,pAKT
actin polymerization in CD4+,CCR4+ cells CD4,CCR5,phalloidin
pSTAT5 in human whole blood on T-cells after IL-2 stimulation pSTAT5
pSTAT5 in human whole blood on granulocytes after GM-CSF stimulation pSTAT5
CCR3 & CD63 after anti-IgE stimulation (fMLP) CCR3,CD63
CD18, CD11b, CD62 and CD45 expression on granulocytes (combi with
stimulation)
CD18,CD11b,CD62L,CD45
Ki67, ICOS, PD-1 AND CTLA-4 CD45, CD3, CD4, CD8, PD-1, ICOS, Ki67, CTLA-4
Receptor Occupancy (RO), Pharmacokinetics
α4-Integrin saturation in Human Whole blood by Flow Cytometry CD45, anti-IgG4
FcGamma RO and phenotyping on granulocytes and monocytes CD45, CD14, CD3, CD19, CD56, CD11c, CD49d
Receptor occupancy on non-classical monocytes in whole blood CD45 PerCP-Cy5.5,CD14 APC,HLA-DR BB515,CD16 BV421,compound + anti-
IgG4-PE.
Fc Receptor occupancy on monocytes - membrane and intracellular CD14,CD66,CD3,CD20,CD45,Fixable Viability Stain 780
C5aR occupancy
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PRAHEALTHSCIENCES
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Version: Q3 2019
Flow Cytometry Lab Assays (continued)
Short description Markers
Receptor Occupancy (RO), Pharmacokinetics (continued)
Receptor occupancy on monocyte precursor cells in human bone marrow compound + IgG4-PE,CD38,7-AAD,CD34,CD3
TLR receptor occupancy on monocytes CD14,CD45,compound + anti-IgG4
CD19 receptor occupancy + CD32b expression IgD,CD45,CD27,CD20,CD3,CD19 + IgD,CD45,CD27,CD20,CD3,CD32b
Other, e.g. Neutralizing antibody assays, Cell cycle status, Cytometric bead array, etc.
Complement pathway in serum using a bead assay C3c,C4d
Cell-cycle determination, cell proliferation (determination of DNA synthesis)
in bone marrow
CD45,CD34,CD38,CDCD11b,CD14,CD61,CD71,Draq5
Neutralizing antibodies CD45 pSTAT3, multiple based on existing receptor occupancy assay format
Cytometric Bead Array (cytokine detection in serum) IL-2,IL-4,IL-6,IL-10,TNF,IFN-γ,IL-17A
The Flow Cytometry department can also perform the following services:
• Full development/transfer of flow cytometry and other cell-based assays
• Assay qualification/Full validation
• Bioanalysis (early through late phase clinical studies)
• Flow cytometry panel design, including optimized fluorochrome selection
• Data analysis using De Novo FCS Express 21 CFR Part 21 compliant software
• Isolation and cryopreservation of Peripheral Blood Mononuclear Cells (PBMC)
• Isolation and cryopreservation of bone marrow Mono Nuclear Cells (MNC)
• Isolation of polymorphonuclear cells from whole blood
• Ex vivo stimulation assays of whole blood and PBMC
• Cell-based neutralizing antibody assays with flow cytometry and/or luminescence read-out
• Cell culture of cell lines for the purpose of cell-based (neutralization) assays
• Basic hematology analysis using Sysmex whole blood analyzer.
PRAHEALTHSCIENCES
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Version: Q3 2019
Clinical Lab: Safety Assays
Clinical Chemistry Coagulation
ACTH Anti-Thrombin III
ALAT aPTT
Albumin D-Dimer
Alkaline Phosphatase Factor V Leiden
Amylase - Pancreas Fibrinogen
Amylase - Total Free Protein C
ASAT Free Protein S
Bicarbonate Plasminogen
Bilirubin - Direct PT
Bilirubin - Total PT (INR)
Bilirubin - Unconjugated (Indirect) TT
Calcium
Chloride Drugs of Abuse
Cholesterol Acetaminophen
Cholinesterase Amphetamines
Creatinine Barbiturates
Creatininekinase (CK) Benzodiazepine
Cystatin C Buprenorphine
Free Fatty Acids Cannabinoids
Fructosamine Cocaine
GGT Ecstacy (XTC)
GLDH Ethanol
Globuline Ethyl Glucuronide
Glucose Gamma Hydroxy-Butyric Acid (GHB)
HBDH MDMA
HDL Cholesterol Metamphetamine
Inorganic Phosphate Methadone
Iron Methaquolone
Iron Binding Capacity - Total (TIBC) Nicotine
Iron Binding Capacity - Unconjugated (UIBC) Opiates
Lactate Phencyclidine
LDH Propoxyphene
LDL Cholesterol Tricyclic Antidepressivants (TCA)
Lipase
Lithium Hematology
Magnesium Absolute Neutrophil Counts (ANC)
Microalbumin Hematocrit (HCT)
NGAL Hemoglobin (HGB)
Potassium Immature Reticulocyte Fraction (IRF)
Sodium Mean Corpuscular Hemoglobin (MCH)
Total Bile Acids Mean Corpuscular Hemoglobin Concentration (MCHC)
Total Protein Mean Corpuscular Volume (MCV)
Triglycerides Mean Platelet Volume (MPV)
Urea/BUN Myeloperoxidase Index (MPXI)
Uric Acid List VLDL Cholesterol continues on next page ⇒
PRAHEALTHSCIENCES
Version: Q3 2019
Clinical Lab: Safety Assays (continued)
Hematology (continued) Urinalysis (semi-quantitative)
Nucleated Red Blood Cells (NRBC) Bilirubin
Platelet Distribution Width (PDW) Colour
Platelets (PLT) Erythrocytes
Red Blood Cells (RBC) Glucose
Red Cell Relative Distribution Width (RDW) Ketones
Reticulocyte Cell Hemoglobin Content (CHr) Leucocytes
Reticulocyte Hb (Ret-Hb) Microscopy (urine sediment)
Reticulocytes (RETIC) Nitrite
White Blood Cell Differentiation (automated) pH
White Blood Cell Differentiation (manual diff) Protein
White Blood Cells (WBC) Specific Gravity
Turbidity
Serology Urobilinogen
Anti-HAV IgM
Anti-HAV Total
Anti-HBc IgM
Anti-HBc Total
Anti-HBs
Anti-HCV
Anti-Mycoplasma Pneumoniae IgG
CMV IgG
CMV IgM
EBV-VCA-IgG
EBV IgG antibodies Nuclear Antigen
EBV-VCA-IgM
H. influenza B IgG
H. pylori IgG
HBsAg
Herpes Simplex IgG
Herpes Simplex IgM
HIV ó, P24 antigen
IgG Antibodies HSV Type 1 and 2
IgM Antibodies HSV Type 1 and 2
Meningococcus IgG
Tetanus Toxin IgG
Tuberculosis (Quantiferon GoldTM)
Varicella Zoster IgG
PRAHEALTHSCIENCES
Version: Q3 2019
Clinical Lab: Specialty / Disease Assays
Anemia Hormones (continued)
Erythropoetin
Folate
Ferritin
FSH
FT3
FT4
Haptoglobin Growth Hormone (GH)
Hepcidin Insulin
Iron Binding Capacity LH
Red-Cell Folate Progesterone
Soluble Transferrin Receptor (sTfR) Prolactin
Transferrin T3
Vitamin B12 T4
Testosterone
Bone Metabolism TSH
Clusterin (APO-J)
CTX-1 Inflammatory
Oteocalcin A1‑Acid Glycoprotein (A1AG)
Osteopontin Alpha-1-Antitrypsin (AAT)
Vitamin D Complement C3
Complement C4
Cardiac C-Reactive Protein (CRP)
Apolipoprotein A‑1 Erythrocyte Sediment Rate (ESR)
Apolipoprotein B IgA
BNP IgE
CKMB IgG
High sensitive CRP IgG-subclasses 1-4
hs Troponin I IgM
Myoglobulin
NT-ProBNP Kidney markers
ST2 β-NAG
Troponin T Aldosteron
KIM-1
Cytokines
IL-1 β Proteins & Peptides
IL-6 Alkaline Phosphatase - Bone & Liver Fraction
IL-8 CK isoenzymes
TNF α Protein Electrophoresis
Hormones Tumor Markers
ACTH Her2neu
Androstenedione PSA
β-HCG
Cortisol Other
Estradiol HbA1c
Occult blood (faeces)
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