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ASSAY LIST October 2021 ASSAY LIST October 2021 Altasciences’ assay list contains proprietary, validated assays suitable for regulated bioanalysis of small molecules, biotherapeutics, and biomarkers. In addition, our custom assay services include substantial experience for development, optimization, and validation of sponsor-specific assays, specifically small molecule and biotherapeutic bioanalysis, immunogenicity testing, and biomarkers using ligand binding platforms and mass spectrometry. altasciences.com 450 973-6077 [email protected] © 2021 Altasciences. All Rights Reserved. 1 Method Status: Validated - Biomarker Analyte Analyte Class Species Matrix Platform Concentration Range 2-HPMA Biomarker Human Urine MS/MS 6500+ and Selexion DMS 2.5 - 750 ng/mL 3-HPMA Biomarker Human Urine MS/MS 6500+ and Selexion DMS 25 - 7500 ng/mL 3-HMPMA Biomarker Human Urine MS/MS 5000 10 - 6000 ng/mL 8-Hydroxy-2-deoxyguanosine Biomarker Human Urine LBA-ELISA-Biotek 35.6 - 612 ng/mL Butyrylcholinesterase Biomarker Human Plasma LBA-fluorometric 0.3 - 20 mU/mL CD14, clone M5E2 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CD16, clone 3G8 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CD20, clone 2H7 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CD3, clone SP34-2 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CD4, clone M-T477 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CD8, clone RPA-T8 Biomarker Monkey Blood LBA - flow cytometry 20000 - events CEMA (2-cyanoethylmercapturic acid) Biomarker Human Urine MS/MS 5000 0.2 - 200 ng/mL Ceruloplasmin Biomarker Human Serum LBA-ELISA-Biotek 2 - 75 ng/mL Ceruloplasmin Ferroxidase Activity Biomarker Human Serum LBA-Colorimetric-Biotek 125 - 1000 mU/mL Complement Bb Biomarker Monkey Plasma LBA-ELISA 75 - 660 ng/mL Complement C3a Biomarker Monkey Plasma LBA-ELISA 50 - 5170 pg/mL Complement CH50 Biomarker Monkey Serum LBA-ELISA 38 - 333 UEq/mL Cotinine Biomarker Human Plasma MS/MS 5000 0.5 - 200 ng/mL C-Reactive protein (CRP) Biomarker Human Plasma LBA-ELISA-Biotek 1.529 - 49 µIU/mL Creatinine Biomarker Human Urine LBA-Spectrophotometric-Biotek 0.2 - 20 mg/dL IFN-γ (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 0.376 - 274 ng/mL IL-10 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 49.52 - 36100 pg/mL IL-12/IL-23p40 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 0.283 - 206 ng/mL IL-1β (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 49.79 - 36300 pg/mL IL-2 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 27.85 - 20300 pg/mL IL-4 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 27.98 - 20400 pg/mL IL-6 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 28.26 - 20600 pg/mL IL-8 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 27.57 - 20100 pg/mL MCP-1 (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 75.17 - 54800 pg/mL TNF-α (panel 1) Biomarker Monkey Serum LBA-Electrochemiluminescence 50.07 - 36500 pg/mL Endothelin-1 Biomarker Human Plasma LBA-ELISA-Biotek 0.5 - 12.50 pg/mL Endothelin-1 Biomarker Human Plasma LBA-ELISA-Biotek 0.5 - 12.5 pg/mL Glucagon Biomarker Human Plasma MS/MS 5000 10 - 500 pg/mL Glucagon Biomarker Human Plasma LBA-ELISA 5 - 250 pg/mL Glutathione (total) Biomarker Human Plasma LBA-Colorimetric-Biotek 1.003 - 13.00 µM Heparin Biomarker Human Plasma LBA-Chromogenic-Biotek 0.05 - 1.2 IU/mL Interleukin-1 Beta Biomarker Human Urine LBA-ELISA-MSD 20 - 7500 IU/dL Interleukin-6 (IL-6, with TNF-α) Biomarker Human Serum LBA-ELISA-MSD 0.644 - 170.7 pg/mL Lipid Peroxidation (Thiobarbituric Acid Biomarker Human Urine LBA-Spectrophotometric-Biotek 260 - 16700 nM Reactive Substances (TBARS)) Magnesium Biomarker Human Serum LBA-colorimetric-Biotek 0.6 - 5 mg/dL Monocyte Chemoattractant Protein-1 Biomarker Human Urine LBA-ELISA-MSD 28 - 2280 mU/mL altasciences.com 450 973-6077 [email protected] © 2021 Altasciences. All Rights Reserved. 2 Method Status: Validated - Biomarker Analyte Analyte Class Species Matrix Platform Concentration Range Nicotine (nicotine equivalents) Biomarker Human Urine MS/MS 5000 10 - 10000 ng/mL [Cotinine] Biomarker Human Urine MS/MS 5000 10 - 5000 ng/mL [Cotinine-N-glucuronide] Biomarker Human Urine MS/MS 5000 20 - 10000 ng/mL [Nicotine-N-glucuronide] Biomarker Human Urine MS/MS 5000 10 - 5000 ng/mL [trans-3'-Hydroxycotinine] Biomarker Human Urine MS/MS 5000 10 - 10000 ng/mL [trans-3'-Hydroxycotinine-O- Biomarker Human Urine MS/MS 5000 50 - 15000 ng/mL glucuronide] NNAL (total) Biomarker Human Urine MS/MS 6500+ and Selexion DMS 5 - 1000 pg/mL NNN (N'-Nitrosonornicotine) (total) Biomarker Human Urine MS/MS 6500+ and Selexion DMS 0.2 - 200 pg/mL Omega-3 ethyl esters (DHA ethyl Biomarker Human Plasma MS/MS 5000 0.5 - 200 ng/mL ester) Omega-3 ethyl esters (EPA ethyl ester) Biomarker Human Plasma MS/MS 5000 0.5 - 200 ng/mL Omega-3 free (unconjugated DHA) Biomarker Human Plasma MS/MS 5000 40 - 2500 ng/mL Omega-3 free (unconjugated EPA) Biomarker Human Plasma MS/MS 5000 10 - 1000 ng/mL Omega-3 total (total DHA) Biomarker Human Plasma MS/MS 5000 10 - 200 µg/mL Omega-3 total (total EPA) Biomarker Human Plasma MS/MS 5000 2 - 200 µg/mL Omega-3 total (total DHA) Biomarker Dog Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total DHA) Mouse Biomarker Mouse Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total EPA) Mouse Biomarker Mouse Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total EPA) Biomarker Dog Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total ALA, alpha- Biomarker Human Plasma MS/MS 5500 5 - 200 µg/mL linolenic acid) Omega-3 total (total DPA, Biomarker Human Plasma MS/MS 5500 5 - 100 µg/mL docosapentaenoic acid) Omega-3 total (total DHA) Biomarker Rabbit Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total EPA) Biomarker Rabbit Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total DHA) Biomarker Rat Plasma MS/MS 5000 2 - 400 µg/mL Omega-3 total (total EPA) Biomarker Rat Plasma MS/MS 5000 2 - 400 µg/mL Protein carbonyl Biomarker Human Serum LBA-ELISA-Biotek 0.375 - 6 nmol/mg Sex Hormone Binding Globulin (SHBG) Biomarker Human Serum LBA-ELISA-Biotek 62.5 - 2000 pmol/L Superoxide Dismutase Activity Biomarker Human Serum LBA-Spectrophotometric-Biotek 115 - 1150 U/L Testosterone Biomarker Human Serum MS/MS 5000 25 - 12500 pg/mL [Dihydrotestosterone] Biomarker Human Serum MS/MS 5000 10 - 5000 pg/mL TNF-α (with Interleukin-6) Biomarker Human Serum LBA-ELISA-MSD 0.61 - 80 pg/mL Total Antioxidant Capacity (Trolox) Biomarker Human Serum LBA-Spectrophotometric-Biotek 20 - 200 µM trans-3'-Hydroxycotinine Biomarker Human Plasma MS/MS 5000 1 - 500 ng/mL altasciences.com 450 973-6077 [email protected] © 2021 Altasciences. All Rights Reserved. 3 Method Status: Validated - Biotherapeutics Analyte Analyte Class Species Matrix Platform Concentration Range Albumin Biotherapeutic Human Serum LBA-Colorimetric-Biotek 7.5 - 50 mg/mL Exenatide Biotherapeutic Human Plasma MS/MS 5000 10 - 2000 pg/mL Exenatide Biotherapeutic Human Plasma MS/MS 5000 20 - 2000 pg/mL Exenatide Biotherapeutic Rat Plasma MS/MS 5000 0.1 - 20 ng/mL Glucagon Biotherapeutic Human Plasma MS/MS 5000 0.1 - 10 ng/mL Glucagon Biotherapeutic Human Plasma MS/MS 5000 10 - 500 pg/mL Glucagon Biotherapeutic Rat Plasma MS/MS 5000 0.2 - 40 ng/mL Glucagon Biotherapeutic Mini-pig Plasma MS/MS 5000 0.2 - 40 ng/mL Glucagon Biotherapeutic Rat Plasma MS/MS 5000 0.4 - 40 ng/mL Glucagon Biotherapeutic Human Plasma MS/MS 5000 0.1 - 10 ng/mL Human Growth Hormone (hGH) Biotherapeutic Human Serum LBA-ELISA 40 - 2000 pg/mL IgG Antibodies to Keyhole Limpet Biotherapeutic Monkey Serum LBA-ELISA 0.94 - 30 ng/mL Hemocyanin (KLH) IgM Antibodies to Keyhole Limpet Biotherapeutic Monkey Serum LBA-ELISA 12.5 - 400 ng/mL Hemocyanin (KLH) Insulin glargine Biotherapeutic Human Plasma MS/MS 5000 50 - 10000 pg/mL [Insulin glargine M1] Biotherapeutic Human Plasma MS/MS 5000 50 - 10000 pg/mL [Insulin glargine M2] Biotherapeutic Human Plasma MS/MS 5000 50 - 10000 pg/mL Lanreotide Biotherapeutic Human Plasma MS/MS 5000 50 - 15000 pg/mL Pembrolizumab Biotherapeutic Human Serum LBA-ELISA 3 - 52 µg/mL Protein concentration Biotherapeutic Human Serum LBA-ELISA-Biotek 50 - 2000 µg/mL Rituximab Biotherapeutic Human Plasma MS/MS 5000 4 - 400 µg/mL Total protein BCA Biotherapeutic Nap nap LBA-Colorimetric 50 - 2000 µg/mL Method Status: Validated - Small Molecules Analyte Analyte Class Species Matrix Platform Concentration Range (1S,2S)-(+)-Pseudoephedrine Small Molecule Human Plasma MS/MS 3000 2 - 600 ng/mL Doxepin (E) Small Molecule Human Plasma MS/MS 5500 0.1 - 50 ng/mL Doxepin (Z) Small Molecule Human Plasma MS/MS 5500 10 - 10000 pg/mL 1,3-Propanediol Small Molecule Rat Plasma MS/MS 5000 0.2 - 100 µg/mL 3-Ketodesogestrel (after desogestrel Small Molecule Human Plasma MS/MS 5000 25 - 5000 pg/mL administration) (Female) Abacavir (with dolutegravir and Small Molecule Human Plasma MS/MS 3000 25 - 10000 ng/mL lamivudine) Abacavir (with lamivudine) Small Molecule Human Plasma MS/MS 3000 25 - 10000 ng/mL Abiraterone Small Molecule Human Plasma MS/MS 5000 0.2 - 250 ng/mL Acetaminophen Small Molecule Human Plasma MS/MS 3000 0.1 - 30 µg/mL Acetazolamide Small Molecule Human Plasma MS/MS 3000 0.1 - 40 µg/mL Acetylsalicylic acid Small Molecule Human Plasma MS/MS 5000 5 - 5000 ng/mL [Salicylic acid] Small Molecule Human Plasma MS/MS 5000 50 - 20000 ng/mL altasciences.com 450 973-6077 [email protected] © 2021 Altasciences. All Rights Reserved. 4 Method Status: Validated - Small Molecules Analyte Analyte
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