VITROS MicroWell Assay Summary

Transcription

1 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 AFP Anti-HAV IgM Anti-HAV Total Anti-Hc RE A IU/mL ( ng/ml) (ng/ml = IU/mL 1.04) IU/mL ( 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 < and <1.20 < and < and < < and <1.20 and < : 10 Anti-Hc IgM 2 Hc M Anti- He 2 ahe Anti-Hc IgM Anti-He Anti-Hc IgM Qualitative Qualitative Reactive He N/A Qualitative Qualitative Reactive < and 1.20 < and <1.20, reconstituted; Anti- Hs 2 ahs Anti- HCV 2 ahcv Anti-Hs Anti-HCV Anti-Hs miu/ml 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 < and <1.00 Anti-HIV ahiv Anti-HIV Anti-HIV N/A Qualitative Qualitative Reactive 1.0 < and <1.0 1/12

2 CA 125 II CA CA 125 II U/mL U/mL Normal Adults (98.5%) 35 U/mL CA 15-3 CA CA U/mL U/mL Normal Adults (98%) 35 U/mL CA 19-9 CA CA U/mL U/mL Normal Adults (97%) 37 U/mL CEA CEA CEA ng/ml 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) CK-M CMV IgG CMV IgM Cortisol ng/ml ng/ml Apparently Healthy (upper 97.5 percentile) Serum Heparin Plasma EDTA Plasma U/mL U/mL Reactive Qualitative Qualitative Reactive Metab-olism nmol/l ( µg/dl) (μg/dl = nmol/l ) nmol/l ( 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 U/mL 8.00 U/mL < and < nmol/l μg/dl nmol/l μg/dl nmol cortisol/24 hours μg cortisol/24 hours : 4, reconstituted at 2 8 C, reconstituted, reconstituted Reagent Pack: 7 2/12

3 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 C-pep Estradiol Ferritin 53 (S) (P H ) or 25 (W H) (W E) 73 Folate Frozen ng/ml ( pmol/l) RE A ,000 pmol/l ( pg/ml) (pg/ml= pmol/l x ) ng/ml ( pmol/l) ,000 pmol/l ( pg/ml) ng/ml ( pmol/l) Normal Follicular Phase Normal Pre ovulatory Normal Luteal Phase Post Menopause Normal Males pmol/l pg/ml pmol/l pg/ml pmol/l pg/ml pmol/l pg/ml pmol/l pg/ml : 7 Day at 2 8 C; 13 at -20 C, Reconstituted Reagent Pack:12 Anemia ng/ml ng/ml, reconstituted Females: <50 yrs 50 yr Males ng/ml ng/ml ng/ml N/A ng/ml ( nmol/l) (nmol/l = ng/ml 2.265) 3/ ng/ml ( 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 ng/ml nmol/l ng/ml nmol/l ng/ml 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

4 Free PSA fpsa Free T3 FT Free PSA Free T3 Free Thyroid Do not dilute Do not dilute ng/ml pmol/l ( pg/ml) (pg/ml = pmol/l 0.651) ng/ml Probability (95% C.I.)of Finding Prostate Cancer on Needle iopsy %fpsa years years 70 years pmol/l ( pg/ml) ( ) ( ) ( ) > ( ) Euthyroid Reference Interval 70.5 ( ) 45.8 ( ) 42.1 ( ) 19.2 ( ) pmol/l pg/ml 72.0 ( ) 47.6( ) 43.8 ( ) 20.3 ( ) : 13 Weeks at 2 8 C NA at -20 C : 4, reconstituted Free T4 FT Free T4 Free Thyroid Do not dilute pmol/l ( ng/dl) (ng/dl = pmol/l ) pmol/l ( ng/dl) Euthyroid Reference Interval (central 98%) pmol/l ng/dl : 4, reconstituted FSH FSH FSH RE N/A miu/ml miu/ml Normal female follicular phase miu/ml Normal female mid-cycle peak (observed range) miu/ml Normal female luteal phase miu/ml Post-menopausal females miu/ml Normal males miu/ml 4/12

5 HeAg 2 HeAg HsAg 2 HsAg HsAg ES 2 HsAg HIV Combo 2 HIV c Insulin Ins 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 HsAg HsAg HIV Combo 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? µiu/ml ( pmol/l) µiu/ml ( pmol/l) < and < and < < and < < 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

6 Intact PTH ipth Intact PTH Intact PTH Do not dilute pg/ml ( pmol/l) pg/ml ( pmol/l) pg/ml ( pmol/l) : 1 Day at 2 8 C 13 Week at -20 C LH LH Myoglobin Myog LH Myoglobin RE N/A miu/ml ng/ml miu/ml exception of the mid-peak cycle Normal female follicular miu/ml phase Normal female mid-cycle miu/ml peak (observed range) Normal female luteal phase Post-menopausal females miu/ml miu/ml 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 (AKIRISK Score) Risk of developing moderate or severe AKI within 12 hours: TIMP-2 TIMP2 IGFP-7 IGFP Urine NephroCheck Test NephroCheck Test N/A N/A ng/ml ng/ml Lower risk Increased risk Highest risk 0.30 >0.30 >2.00 : 10 at 2-8 ºC, reconstituted 6/12

7 N-Telopeptide NTx NTNP NTNP Urine (2 nd morning void) NTx NT-proNP NTx A nm CE nm CE (central 95 percentile) Postmenopausal nm CE/mM creatinine Premenopausal nm CE/mM creatinine Males ,000 pg/ml ( pmol/l) (pmol/l = pg/ml 0.118) ,000 pg/ml ( pmol/l) Patients under 75 years Patients 75 years and older 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 Progest-erone Prolactin PSA RE A nmol/l ( ng/ml) (ng/ml = nmol/l ) RE A miu/l ( ng/ml) (ng/ml = miu/l 0.047) nmol/l ( ng/ml) miu/l ( ng/ml) Follicular Phase Periovulatory Mid luteal Phase Luteal Phase Normal Female Non-pregnant Males nmol/l ng/ml nmol/l ng/ml nmol/l ng/ml nmol/l ng/ml miu/l ng/ml miu/l ng/ml, reconstituted, reconstituted Reagent Pack: 7 : 5 at 2 8 C, reconstituted; 10 at -20 C, reconstituted ng/ml ng/ml Normal Males Subjects 40 years 200 >40 years 167 : 12 <4 ng/ml >4 ng/ml 2 1 Refer to Instructions for Use for Non-malignant Conditions and Malignant Disease : 12 7/12

8 Rubella IgG Rub G Rubella IgM Rub M Syphilis TPA Syph T3 Uptake T3U Testosterone Testo Total -hcg II -hcg Rubella IgG Rubella IgM Syphilis TPA T3 Uptake Testosterone Total -hcg II IU/mL IU/mL Low Positive Positive Qualitative Qualitative Reactive Syphilis TPA N/A Qualitative Qualitative Reactive Total Thyroid N/A 17 65% uptake T3 uptake units Testosterone N/A nmol/l ( ng/dl) (ng/dl = nmol/l 28.84) RE ,000 miu/ml 17 65% uptake T3 uptake units nmol/l ( ng/dl) ,000 miu/ml Euthyroid Reference Interval T3 uptake FT4I TT4 (nmol/l) T3U (%uptake)/100 TT4 (μg/dl) T3U (%uptake)/100 Normal males years Normal males >50 years Females with normal menstrual cycles 9.99 IU/mL IU/mL 15.0 IU/mL and < and < % uptake uptake units nmol/l μg/dl nmol/l ng/dl nmol/l ng/dl nmol/l ng/dl : 2, reconstituted Positive 25 miu/ml, reconstituted Total PSA II tpsa Total PSA II ng/ml 8/ ng/ml Normal Males No. of Subjects <4 ng/ml 4 ng/ml : 40 to 49 years Weeks at 2 8 C 50 to 50 years NA at -20 C 60 to 69 years years Refer to Instructions for Use for Non-malignant Conditions and Malignant Disease

9 Total T3 TT Total T3 Total Thyroid N/A nmol/l ( ng/ml) (ng/ml = nmol/l 0.651) nmol/l ng/ml Euthyroid Reference Interval nmol/l ng/ml Total T4 TT4 Toxoplasma IgG Tox G Toxoplasma IgM Tox M Troponin I ES TropI TSH TSH Vitamin Total T ToxG ToxM Troponin I ES Frozen TSH Vitamin 12 Total Thyroid Free Thyroid or Total Thyroid N/A nmol/l ( µg/dl) (μg/dl = nmol/l ) nmol/l µg/dl Euthyroid Reference Interval IU/mL IU/mL Reactive Qualitative Qualitative Reactive A ng/ml miu/l (µiu/ml) Anemia N/A pg/ml pmol/l (pmol/l = pg/ml 0.738) ng/ml Upper Reference Limit (URL) AMI Diagnostic Cutoff miu/l (µiu/ml) pg/ml pmol/l Euthyroid Reference Interval Normal Adults nmol/l μg/dl 3.99 IU/mL IU/mL 8.00 IU/mL < and < ng/ml ng/ml miu/l (μiu/ml) pg/ml 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

10 VITAMIN D TOTAL tvitd Vitamin D Total N/A ng/ml ( nmol/l) (ng/ml = nmol/l x 2.5) ng/ml ( nmol/l) Deficient <20 ng/ml / (<50 nmol/l) Insufficient 20 <30 ng/ml / (50 <75 nmol/l) Sufficient ng/ml / ( 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 ml Ready to Use Refrigerated: 5 days Anti-Hs ahs ml Distilled Water Refrigerated: 5 days Anti-HCV ahcv ml Distilled Water Refrigerated: 5 days Anti-HIV 1+2 ahiv ml Distilled Water Refrigerated: 5 days Anemia 12, Ferr ml Ready to Use Refrigerated: 8 weeks Anti-HAV IgM HAV M ml Distilled Water Refrigerated: 5 days Anti-HAV Total HAV T ml Distilled Water Refrigerated: 5 days 10/12

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

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 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