VITROS MicroWell Assay Summary

3,63,6 VITROS MicroWell Assay Summary s / Reagents AFP AFP Anti-HAV IgM 2 HAV M Anti-HAV Total 2 HAV T Anti- Hc 2 ahc Amniotic Fluid 25 43 AFP 10 43 Anti-HAV IgM 10 53 Anti-HAV Total 50 55 Anti-Hc RE A 0.476 500 IU/mL (0.495 520 ng/ml) (ng/ml = IU/mL 1.04) 0.476 500 IU/mL (0.495 520 ng/ml) Normal Adults (upper 97.5 percentile) Anti-HAV IgM Qualitative Qualitative Reactive Anti-HAV Total Qualitative Qualitative Antibody Positive Antibody Retest? Anti-Hc Qualitative Qualitative Reactive Retest <7.22 IU/mL <7.51 ng/ml <0.80 0.80 and <1.20 <0.8 0.8 and <1.0 1.0 and <4.0 4.0 <1.00 1.00 and <1.20 and <4.80 4.80 : 10 Anti-Hc IgM 2 Hc M Anti- He 2 ahe 10 43 Anti-Hc IgM 80 53 Anti-He Anti-Hc IgM Qualitative Qualitative Reactive He N/A Qualitative Qualitative Reactive <0.80 0.80 and 1.20 <0.80 0.80 and <1.20, reconstituted; Anti- Hs 2 ahs Anti- HCV 2 ahcv 80 55 Anti-Hs 20 55 Anti-HCV Anti-Hs 4.23 3 1000 miu/ml 4.23 3 1000 miu/ml Antibody Positive Antibody Anti-HCV N/A Qualitative Qualitative Reactive >12 miu/ml <8 miu/ml 8 and 12 miu/ml 1.00 <0.90 0.90 and <1.00 Anti-HIV 1+2 2 ahiv 80 41 Anti-HIV Anti-HIV N/A Qualitative Qualitative Reactive 1.0 <0.9 0.9 and <1.0 1/12

CA 125 II CA125 25 37 CA 125 II 5.5 1000 U/mL 5.5 1000 U/mL Normal Adults (98.5%) 35 U/mL CA 15-3 CA153 10 42 CA 15-3 0.7 500 U/mL 0.7 500 U/mL Normal Adults (98%) 35 U/mL CA 19-9 CA199 35 42 CA 19-9 1.4 1000 U/mL 1.4 1000 U/mL Normal Adults (97%) 37 U/mL CEA CEA 20 38 CEA 0.31 400 ng/ml 0.31 400 ng/ml Healthy Non Smokers (91.9%) & Healthy Smokers (67.3%) 3.0 ng/ml CK-M CK-M CMV IgG CMV G CMV IgM CMV M Cortisol Cort Urine (24-hour) 40 16 CK-M 10 35 CMV IgG 10 68 CMV IgM 25 38 Cortisol 0.22 400 ng/ml 0.22 400 ng/ml Apparently Healthy (upper 97.5 percentile) Serum Heparin Plasma EDTA Plasma 1.62 3 450 U/mL 1.62 3 450 U/mL Reactive Qualitative Qualitative Reactive Metab-olism 4.39 1700 nmol/l (0.16 61.6 µg/dl) (μg/dl = nmol/l 0.03625) 4.39-1700 nmol/l (0.16 61.6 µg/dl) efore 10:00 am After 5:00 pm Urinary Free 3.38 ng/ml 2.37 ng/ml 2.03 ng/ml 4.99 U/mL 5.00 7.99 U/mL 8.00 U/mL <0.90 0.90 and <1.20 123 626 nmol/l 4.46 22.7 μg/dl 46.2 389 nmol/l 1.7 14.1 μg/dl 35.7 699 nmol cortisol/24 hours 12.9 253 μg cortisol/24 hours : 4, reconstituted at 2 8 C, reconstituted, reconstituted Reagent Pack: 7 2/12

C-peptide C-pep Estradiol E2 Ferritin Ferr Folate Fol RCFol Lithium Heparin Plasma (S) (P H) Heparin Whole lood (W H) EDTA Whole lood (W E) Whole lood samples must be treated with VITROS Red Cell Folate Reagent Pack. 40 27 C-pep 25 40 Estradiol 15 42 Ferritin 53 (S) (P H ) or 25 (W H) (W E) 73 Folate Frozen 0.050 30.0 ng/ml (16.6 9930 pmol/l) RE A 23.347 14,000 pmol/l (6.360 3813.6 pg/ml) (pg/ml= pmol/l x 0.2724) 0.050 30.0 ng/ml (16.6 9930 pmol/l) 23.347 14,000 pmol/l (6.360 3813.6 pg/ml) 0.727 3.68 ng/ml (241 1218 pmol/l) Normal Follicular Phase Normal Pre ovulatory Normal Luteal Phase Post Menopause Normal Males 97.5 592 pmol/l 26.6 161 pg/ml 685 1404 pmol/l 187 382 pg/ml 120 738 pmol/l 32.7 201 pg/ml 19.7 141 pmol/l 5.37 38.4 pg/ml 19.7 242 pmol/l 5.37 65.9 pg/ml : 7 Day at 2 8 C; 13 at -20 C, Reconstituted Reagent Pack:12 Anemia 0.29 1000 ng/ml 0.29 1000 ng/ml, reconstituted Females: <50 yrs 50 yr Males 6.24 137 ng/ml 11.1 264 ng/ml 17.9 464 ng/ml N/A 0.34 20.0 ng/ml (0.77 45.3 nmol/l) (nmol/l = ng/ml 2.265) 3/12 0.34 20.0 ng/ml (0.77 45.3 nmol/l) Serum/Plasma Normal Adults Serum/Plasma Folate-Deficient Patients Whole lood Nomal Adults Whole lood Folate-Deficient Patients 2.76 >20 ng/ml 6.25 >45.3 nmol/l 1.04 2.79 ng/ml 2.36 6.32 nmol/l 141 1018 ng/ml 319 2306 nmol/l 31.2 146 ng/ml 70.7 331 nmol/l : 3 Day at 2 8 C; 4 Week at -18 C or below Reagent Pack 1/2: 8 Reagent Pack 3: 8 Red Cell Folate: 7 Day at 2 8 C, reconstituted : 3 Day at 2 8 C; 4 Week at -18 C or below Reagent Pack 1/2: 8 Reagent Pack 3: 4 Red Cell Folate: 7 Day at 2 8 C, reconstituted

Free PSA fpsa Free T3 FT3 30 24 Free PSA 25 24 Free T3 Free Thyroid Do not dilute Do not dilute 0.015 50 ng/ml 0.77 35.0 pmol/l (0.50 22.8 pg/ml) (pg/ml = pmol/l 0.651) 0.015 50 ng/ml Probability (95% C.I.)of Finding Prostate Cancer on Needle iopsy %fpsa 50-59 years 60-69 years 70 years 0.77 35.0 pmol/l (0.50 22.8 pg/ml) 10 56.0 (39.2 71.6) 11 18 31.0 (18.6 47.0) 19 25 27.9 (14.8 46.3) >25 11.2 (4.36 26.0) Euthyroid Reference Interval 70.5 (56.5 81.5) 45.8 (35.9 56.1) 42.1 (28.2 57.4) 19.2 (9.05 36.2) 4.26 8.10 pmol/l 2.77 5.27 pg/ml 72.0 (56.0 83.8) 47.6(35. 4 60.1) 43.8 (29.5 59.3) 20.3 (9.63 37.9) : 13 Weeks at 2 8 C NA at -20 C : 4, reconstituted Free T4 FT4 25 24 Free T4 Free Thyroid Do not dilute 0.88 90.0 pmol/l (0.07 6.99 ng/dl) (ng/dl = pmol/l 0.0777) 0.88 90.0 pmol/l (0.07 6.99 ng/dl) Euthyroid Reference Interval (central 98%) 10.0 28.2 pmol/l 0.78 2.19 ng/dl : 4, reconstituted FSH FSH 40 24 FSH RE N/A 0.66 200 miu/ml 0.66 200 miu/ml Normal female follicular phase 1.98 11.6 miu/ml Normal female mid-cycle peak (observed range) 5.14 23.4 miu/ml Normal female luteal phase 1.38 9.58 miu/ml Post-menopausal females 21.5 131 miu/ml Normal males 1.55 9.74 miu/ml 4/12

HeAg 2 HeAg HsAg 2 HsAg HsAg ES 2 HsAg HIV Combo 2 HIV c Insulin Ins 80 37 HeAg Freezedried Separator Tube (SST) Plasma Separator Tube (PST) Lithium heparin plasma Sodium heparin plasma Potassium EDTA plasma Sodium citrate plasma Acid Citrate Dextrose (ACD) Citrate Phosphate Dextrose (CPD) Citrate Phosphate Dextrose Adenine (CPDA-1) Lithium heparin plasma 80 37 HsAg 80 37 HsAg 80 48 HIV Combo 20 24 Ins He N/A Qualitative Qualitative Reactive HsAg N/A Qualitative Qualitative Reactive HsAg N/A Qualitative Qualitative Reactive N/A Qualitative Qualitative Reactive Retest? 1.00 300 µiu/ml (6.00 1800 pmol/l) 1.00 300 µiu/ml (6.00 1800 pmol/l) <0.80 0.80 and 1.20 1.00 <0.90 0.90 and <1.00 1.00 <0.90 0.90 and <1.00 1.0 <0.9 0.9 and <1.0 : 5 at 2 8 C reconstituted; 13 at -20 C reconstituted : 12 at 2-8 ºC Lower Limit 2.30 µiu/ml 13.8 pmol/l Reagent Pack:12 Upper Limit 26.0 µiu/ml 156 pmol/l 5/12

Intact PTH ipth 80 18 Intact PTH Intact PTH Do not dilute 3.4 5000 pg/ml (0.4 530 pmol/l) 3.4 5000 pg/ml (0.4 530 pmol/l) 7.5 53.5 pg/ml (0.8 5.7 pmol/l) : 1 Day at 2 8 C 13 Week at -20 C LH LH Myoglobin Myog 50 24 LH 10 16 Myoglobin RE N/A 0.216 200 miu/ml 0.9 2000 ng/ml 0.216 200 miu/ml exception of the mid-peak cycle Normal female follicular 2.58 12.1 miu/ml phase Normal female mid-cycle 27.3 96.9 miu/ml peak (observed range) Normal female luteal phase Post-menopausal females 0.833 15.5 miu/ml 13.1 86.5 miu/ml 0.9 2000 ng/ml (upper 97.5 percentile) All Individuals Male Female 101 ng/ml (μg/l) 121 ng/ml (μg/l) 61.5 ng/ml (μg/l) : 24 Hour at 2 8 C, reconstituted : 24 Hour at 2 8 C, reconstituted NephroCheck NCHEK 0.04 10.0 (AKIRISK Score) Risk of developing moderate or severe AKI within 12 hours: TIMP-2 TIMP2 IGFP-7 IGFP Urine 35 20 16 16 NephroCheck Test NephroCheck Test N/A N/A 2.0 25.0 ng/ml 20.0 400.0 ng/ml Lower risk Increased risk Highest risk 0.30 >0.30 >2.00 : 10 at 2-8 ºC, reconstituted 6/12

N-Telopeptide NTx NTNP NTNP Urine (2 nd morning void) 25 38 NTx 40 16 NT-proNP NTx A 15 3000 nm CE 15 3000 nm CE (central 95 percentile) Postmenopausal 26 124 nm CE/mM creatinine Premenopausal 17 94 nm CE/mM creatinine Males 11.1 35,000 pg/ml (1.31 4130 pmol/l) (pmol/l = pg/ml 0.118) 11.1 35,000 pg/ml (1.31 4130 pmol/l) Patients under 75 years Patients 75 years and older 21 83 nm CE/mM creatinine 125 pg/ml 14.8 pmol/l 450 pg/ml 53.1 pmol/l at 2 8 C Progesterone Prog Prolactin Prol PSA PSA 25 24 Progest-erone 35 24 Prolactin 15 37 PSA RE A 0.253 178 nmol/l (0.080 56.0 ng/ml) (ng/ml = nmol/l 0.3145) RE A 30.8 7000 miu/l (1.4 329 ng/ml) (ng/ml = miu/l 0.047) 0.253 178 nmol/l (0.080 56.0 ng/ml) 30.8 7000 miu/l (1.4 329 ng/ml) Follicular Phase Periovulatory Mid luteal Phase Luteal Phase Normal Female Non-pregnant Males 0.44 6.47 nmol/l 0.14 2.03 ng/ml 1.27 14.2 nmol/l 0.40 4.47 ng/ml 16.6 72.2 nmol/l 5.22 22.7 ng/ml 4.53 52.9 nmol/l 1.42 16.6 ng/ml 64 395 miu/l 3.0 18.6 ng/ml 78 380 miu/l 3.7 17.9 ng/ml, reconstituted, reconstituted Reagent Pack: 7 : 5 at 2 8 C, reconstituted; 10 at -20 C, reconstituted 0.064 100 ng/ml 0.064 100 ng/ml Normal Males Subjects 40 years 200 >40 years 167 : 12 <4 ng/ml 198 166 >4 ng/ml 2 1 Refer to Instructions for Use for Non-malignant Conditions and Malignant Disease : 12 7/12

Rubella IgG Rub G Rubella IgM Rub M Syphilis TPA Syph T3 Uptake T3U Testosterone Testo Total -hcg II -hcg 10 35 Rubella IgG 10 43 Rubella IgM 25 35 Syphilis TPA 10 24 T3 Uptake 25 40 Testosterone 40 24 Total -hcg II 0.58 3 350 IU/mL 0.58 3 350 IU/mL Low Positive Positive Qualitative Qualitative Reactive Syphilis TPA N/A Qualitative Qualitative Reactive Total Thyroid N/A 17 65% uptake 2.21 0.515 T3 uptake units Testosterone N/A 0.170 75.0 nmol/l (4.90 2160 ng/dl) (ng/dl = nmol/l 28.84) RE 2.39 15,000 miu/ml 17 65% uptake 2.21 0.515 T3 uptake units 0.170 75.0 nmol/l (4.90 2160 ng/dl) 2.39 15,000 miu/ml Euthyroid Reference Interval T3 uptake FT4I TT4 (nmol/l) T3U (%uptake)/100 TT4 (μg/dl) T3U (%uptake)/100 Normal males 20 49 years Normal males >50 years Females with normal menstrual cycles 9.99 IU/mL 10.0 14.9 IU/mL 15.0 IU/mL 0.80 0.80 and <1.20 0.80 0.80 and <1.20 23.5 40.5% uptake 1.37 0.736 uptake units 21.2 49.8 nmol/l 1.65 3.89 μg/dl 4.56 28.2 nmol/l 132 813 ng/dl 2.49 21.6 nmol/l 71.8 623 ng/dl 0.198 2.67 nmol/l 5.71 77.0 ng/dl : 2, reconstituted Positive 25 miu/ml, reconstituted Total PSA II tpsa 30 24 Total PSA II 0.010 100 ng/ml 8/12 0.010 100 ng/ml Normal Males No. of Subjects <4 ng/ml 4 ng/ml : 40 to 49 years 81 81 0 13 Weeks at 2 8 C 50 to 50 years 78 77 1 NA at -20 C 60 to 69 years 80 77 3 70 + years 38 33 5 Refer to Instructions for Use for Non-malignant Conditions and Malignant Disease

Total T3 TT3 20 37 Total T3 Total Thyroid N/A 0.103 12.0 nmol/l (0.067 7.81 ng/ml) (ng/ml = nmol/l 0.651) 0.103 12.0 nmol/l 0.067 7.81 ng/ml Euthyroid Reference Interval 1.49 2.60 nmol/l 0.970 1.69 ng/ml Total T4 TT4 Toxoplasma IgG Tox G Toxoplasma IgM Tox M Troponin I ES TropI TSH TSH Vitamin 12 12 10 24 Total T4 10 35 ToxG 10 43 ToxM 80 18 Troponin I ES Frozen 80 37 TSH 30 57 Vitamin 12 Total Thyroid Free Thyroid or Total Thyroid N/A 5.21 320 nmol/l (0.405 24.9 µg/dl) (μg/dl = nmol/l 0.0777) 5.21 320 nmol/l 0.405 24.9 µg/dl Euthyroid Reference Interval 2.72 3 500 IU/mL 2.72 3 500 IU/mL Reactive Qualitative Qualitative Reactive A 0.012 80.0 ng/ml 0.015 100 miu/l (µiu/ml) Anemia N/A 159 1000 pg/ml 117 738 pmol/l (pmol/l = pg/ml 0.738) 0.012 80.0 ng/ml Upper Reference Limit (URL) AMI Diagnostic Cutoff 0.015 100 miu/l (µiu/ml) 159 1000 pg/ml 117 738 pmol/l Euthyroid Reference Interval Normal Adults 71.2 141 nmol/l 5.53 11.0 μg/dl 3.99 IU/mL 4.00 7.99 IU/mL 8.00 IU/mL <0.80 0.80 and <1.20 0.034 ng/ml 0.120 ng/ml 0.465 4.68 miu/l (μiu/ml) 239 931 pg/ml 176 687 pmol/l Reagent Pack: 4 : 6 at 2 8 C Reagent Pack 1/2: 12 Reagent Pack 3: 8 Reagent Pack 1/2: 12 Reagent Pack 3: 4 9/12

VITAMIN D TOTAL tvitd 60 24 Vitamin D Total N/A 8.00 150 ng/ml (20.0 375 nmol/l) (ng/ml = nmol/l x 2.5) 8.00 150 ng/ml (20.0 375 nmol/l) Deficient <20 ng/ml / (<50 nmol/l) Insufficient 20 <30 ng/ml / (50 <75 nmol/l) Sufficient 30 100 ng/ml / (75 250 nmol/l) Potential Toxicity >100 ng/ml / (>250 nmol/l) : 7 days at 2 8 C, reconstituted; 13 at -20 C, reconstituted Derived Tests Calculation Derived Tests Calculation Derived Tests Calculation FT3I Free T3 Index (TT3/T3 uptake units) (TT3 T3 uptake %)/100 (TT3 T3 uptake %) FT4I Free T4 Index (TT4/T3 uptake units) (TT4 T3 uptake %)/100 (TT4 T3 uptake %) %fpsa %Free PSA (fpsa/tpsa 100) L/F LH/FSH Ratio (LH/FSH) T3/T4 T3/T4 Ratio (TT3/TT4) NCHEK AKIRisk (TIMP2*IGFP)/1000 Product Name Related Tests Packaging (number per box) Levels Volume Reconstitution / Fluid Anti-Hc ahc 3 2 1.0 ml Ready to Use Refrigerated: 5 days Anti-Hs ahs 3 3 2.0 ml Distilled Water Refrigerated: 5 days Anti-HCV ahcv 3 2 1.0 ml Distilled Water Refrigerated: 5 days Anti-HIV 1+2 ahiv 3 3 1.0 ml Distilled Water Refrigerated: 5 days Anemia 12, Ferr 3 3 2.2 ml Ready to Use Refrigerated: 8 weeks Anti-HAV IgM HAV M 3 2 1.0 ml Distilled Water Refrigerated: 5 days Anti-HAV Total HAV T 3 2 1.0 ml Distilled Water Refrigerated: 5 days 10/12

Product Name Related Tests Packaging (number per box) Levels Volume Reconstitution / Fluid Anti-Hc IgM Hc M 3 2 0.5 ml Distilled Water Refrigerated: 5 days Free Thyroid FT3, FT4, TSH 3 3 1.0 ml Distilled Water Refrigerated: 5 days He ahe, HeAg 3 3 1.0 ml Distilled Water Refrigerated: 5 days HsAg HsAg 3 2 1.6 ml Distilled Water Refrigerated: 5 days Intact PTH ipth 3 3 1.0 ml Distilled Water Refrigerated: 5 days Metabolism Cort 3 3 1.0 ml Distilled Water Refrigerated: 5 days NephroCheck TIMP-2, IGFP-7, NCHEK 3 3 1.0 ml Distilled Water Refrigerated: 13 weeks Frozen: 13 weeks NTx NTx 3 3 1.0 ml Ready to Use Refrigerated: 5 days RE AFP, -hcg, E2, FSH, LH, Prog, Prol 3 3 1.0 ml Distilled Water Refrigerated: 5 days Syphilis TPA Syph 3 2 1.0 ml Ready to Use Refrigerated: 13 weeks Frozen: 13 weeks Testosterone Testo 3 3 1.0 ml Distilled Water Refrigerated: 5 days Total Thyroid T3U, TSH, TT3, TT4 3 3 1.0 ml Distilled Water Refrigerated: 5 days 11/12

s VITROS MicroWell Assay Summary Product Name High Sample A Reagent Pack (GEM4901) High Sample A (Man) (GEM4911) High Sample Reagent Pack (GEM4902) High Sample (Man) (GEM4912) Related Tests Packaging (number per box) Reconstitution / Fluid Storage & Open Stability AFP, E2, Prog, Prol, NTx, TSH 1 diluent pack Ready to Use Refrigerated: 8 weeks 8 weeks AFP, E2, Prog, Prol, NTx, TSH 4 bottles Ready to Use Refrigerated: 8 weeks 8 weeks ahc, ahs, -hcg, CA125, CA153, CA199, CEA, CK-M, CMVG, Cort, Ferr, HAV T, Myog, NTNP, PSA, Rub G, Tox G, Trop I ahc, ahs, -hcg, CA125, CA153, CA199, CEA, CK-M, CMV G, Cort, C-pep, Ferr, HAV T, Ins, Myog, NTNP, PSA, Rub G, Tox G, Trop I 1 diluent pack Ready to Use Refrigerated: 8 weeks 8 weeks 4 bottles Ready to Use Refrigerated: 8 weeks 8 weeks This information was current as of the publication date. The Instructions for Use are the authorized source for information about VITROS Immunodiagnostic Products. Not all products and systems are available in all countries. 1. Open calibrators, controls and diluents can be stored at either 2 8 C or -20 C for the duration stated; Open reagent packs can be stored on the system or at 2 8 C in a sealed reagent pack storage box containing dry desiccant. 2. Hepatitis and HIV tests are co-developed with Grifols Diagnostic Solutions, Inc., Emeryville, CA, USA. 3. Lower limit reported by the system software is 0 (with the appropriate units for the assay). Ortho-Clinical Diagnostics, Inc., 2017 VITROS is a trademark of Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626. CA 125 II, CA 15-3, & CA 19-9 are trademarks of Fujirebio Diagnostics, Inc. NEPHROCHECK is a registered trademark of Astute Medical, Inc. in the United States. AKIRISK is a trademark of Astute Medical, Inc. 12/12