ELISA. AccuDiag Autoimmune Diseases and Others. ANA Screen Qualitative ~135 min 90.4% 100%
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1 / AccuDiag Autoimmune Diseases and Others ANA Screen ~135 min 90.4% 100% ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ~ 60 min 96% 100% ENA Combined Screen (6 antigens) Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B ~ 75 min 93% 100% Sm/RNP Sm Jo Scl SS-A (Ro) SS-B (La) dsdna ~ 60 min 92% 97% ~ 60 min 100% 99.3% ~ 60 min 100% 100% ~ 60 min 100% 100% ~ 60 min 98.2% 100% ~ 60 min 96.6% 100% ~ 65 min 100% 97.9% Anti-Phospholipid ~ 60 min 0.5 U/mL N/A 1
2 Cardiolipin IgG Cardiolipin IgM / Cardiolipin IgA Cardiolipin IgG, A, M (Min. Order 2 kits) / Beta 2 Glycoprotein 1 IgA Beta 2 Glycoprotein 1 IgG Beta 2 Glycoprotein 1 IgM ~90 min 10 GPL 100% 10 MPL 95% 10.0 APL 100% 100% 98.5% 98% 91% 91% 92% 92.6% 85.4% Histone (Min. Order 2 kits) % 90.9% Rheumatoid Factor (RF) ~ 65 min 100% 98.7% Mitochondria ~ 60 min 100% 100% Thyroglobulin TPO PR3 (c-anca) ~ 75 min 100% 96.7% ~ 60 min 93.7% 94.4% ~ 75 min 98.2% 95.6% ANCA Screen IgG ~ 60 min 97.4% 94.9% MPO, Myeloperoxidase (p-anca) ~ 60 min 98.9% 97.9% Gliadin IgG Gliadin IgA / / ~ 60 min 95.6% 95.1% ~ 60 min 93.9% 96.2% Anti CCP (New) ~105 min 79% 97% Anti Tissue Transglutaminase IgA (New) % 100% Anti Tissue Transglutaminase IgG (New) % 90.9% 2
3 / AccuDiag Cancer (Tumor Marker) Prostatic Acid Phosphatase (PAP) Beta 2-Microglobulin PSA AFP (Alpha Fetoprotein) CEA ~ 75 min ~ 80 min ~ 140 ~ 80 min ~ 80 min 0.2 ng/ml 98.7% 2 µg/ml 96% 0.5 ng/ml 98.7% 2 ng/ml 98.5% 1 ng/ml 95% CA ~ 140 CA min ~ 200 CA ~ 140 NSE ~ 80 min Free Beta HCG ~ 80 min Free PSA ~160 min AccuDiag Cardiac Markers 5 U/mL 97.5% 5 U/mL 97% 5 U/mL 97% 15 ng/ml 98.7% 0.5 miu/ml 100% 0.05 ng/ml 98.7% Digoxin ~ 45 min 0.05 ng/ml 96% 3
4 Product Name Catalog # # of / CK-MB ~45 min 0.5 ng/ml 96% Troponin I ~110 min 1 ng/ml 96% Myoglobin ~ 65 min 5 ng/ml 96% C-Reactive Protein (CRP) ~65 min 0.01 ng/ml 96% Lp (a) ~150 min 3 µg/dl 90% AccuDiag Allergy Human IgE ~80 min 5 Lu/mL 98.7% Human IgA ~120 min 0.05 µg/ml 100% Human IgG ~105 min N/A N/A Human IgM ~150 min 0.05 µg/ml 100% Human Allergen Specific IgE ~150 min N/A N/A Human Allergen Specific IgA ~150 min N/A N/A Human Allergen Specific IgG ~105 min N/A N/A Human Allergen Specific IgM ~150 min N/A N/A 4
5 Product Name Catalog # # of / AccuDiag Anemia Folate ~65 min 0.52 ng/ml N/A Ferritin ~ 80 min 5 ng/ml 98.5% Vitamin B ~ 95 min pg/ml N/A stfr- SolubleTransferrin Receptor ~ 90 min nmol/l N/A 25-OH Vitamin D (total) ~ 105 min ng/ml N/A AccuDiag Fertility Human Growth Hormone (HGH) ~ 80 min 1 ng/ml 96% Beta hcg () ~ 80 min 2 miu/ml 97% hcg Visual ~ 20 min 1 ng/ml 95% FSH ~ 80 min 2.5 miu/ml 96% LH ~ 80 min 2 miu/ml 96% PAPP-A µg/ml 96% 5
6 Product Name Catalog # # of / Prolactin (PRL) ~ 80 min 2 ng/ml 96% AccuDiag Bone Metabolism Intact PTH ~220 min 1.57 pg/ml 100% AccuDiag Steroids Testosterone Saliva ~100 min 1.0 pg/ml 100% Cortisol Saliva ~ 60 min 1.0 ng/ml 100 % Cortisol ~ 75 min 0.25 µg/dl 97% Estradiol ~ 110 min 10 pg/ml 97% DHEA-S ~ 75 min 4.5 ng/ml 95% Progesterone ~ 110 min 0.06 ng/ml 97% Testosterone ~ 110 min 0.05 ng/ml 100% 6
7 / Free Testosterone ~ 110 min 0.6 pg/ml 100% Androstenedione (ASD) ~ 80 min 0.4 ng/ml 100% Free Estriol alpha Hydroxy Progesterone ~ 75 min 0.1 ng/ml 100% ~ 110 min 0.1 ng/ml 100% Dihydro-Testosterone SHBG ~ 75 min 6 pg/ml ~ 60 min 0.2 nmol/ml 100% 100% AccuDiag Thyroid (Endocrinology) T ~80 min 0.2 ng/ml 96.3% T ~80 min 0.5 µg/ml 96.3% TSH ~80 min 0.2 µiu/ml 100% TSH Ultra Sensitive ~140 min 0.05 µiu/ml 96% Free T ng/ml 97% Free T pg/ml 97% % T3 Uptake N/A 0.4 µiu/ml 97% NTSH ( NeoNatal TSH) X 96 ~180 min NNT4 (NeoNatal T4) µg/ml 97% 7
8 / AccuDiag Infectious Disease Dengue IgG/IgM ~25 min 100% 78% Dengue IgG ~25 min 94.7% 97.4% Dengue IgM ~40 min 93.5% 97.8% Dengue NS1 Antigen ELISA ~110 min N/A N/A Adenovirus (Fecal) ~45 min 95.5% 100% Tetanus IgG ~15 min N/A N/A Diphtheria ~15 min N/A% N/A West Nile IgG ~180 min 96.2% 98.4% West Nile IgM ~180 min 96.2% 98.4% Rotavirus (Fecal) ~50 min 100% 97% Japanese Encephalitis IgG ~135 min N/A N/A Japanese Encephalitis IgM ~135 min 100% 100% Bordetella Pertussis IgA Bordetella Pertussis IgG Bordetella Pertussis IgM RSV IgA RSV IgG RSV IgM ~110 min 94% 92% ~110 min 100% 84% ~110 min 88% 100% ~110 min 100% 100% ~110 min 86% 100% ~110 min 86% 100% 8
9 Adenovirus IgA Adenovirus IgG Adenovirus IgM Influenza A IgA Influenza A IgG Influenza A IgM Influenza B IgA Influenza B IgG Influenza B IgM TB IgA TB IgG / 100% 97.7% ~110 min 83% 99% ~110 min 100% 88% ~110 min 100% 100% ~110 min 85% 100% ~110 min 100% 88% ~110 min 100% 100% ~50 min 100% 99% ~110 min 100% 99% TB IgM ~110 min 100% 100% Toxoplasma gondii IgG (Toxo IgG) Toxoplasma gondii IgM (Toxo IgM) Toxoplasma gondii IgA (Toxo IgA) Rubella IgG Rubella IgM ~60 min 95.3% 100% 100% 94% Rubella IgA % 99.2% Cytomegalovirus IgG (CMV IgG) Cytomegalovirus IgM (CMV IgM) Cytomegalovirus IgA (CMV IgA) Herpes Simplex 1 IgG (HSV1 IgG) Herpes Simplex 1 IgM (HSV1 IgM) Herpes Simplex 1 IgA (HSV1 IgA) Herpes Simplex 2 IgG (HSV2 IgG) Herpes Simplex 2 IgM (HSV2 IgM) Herpes Simplex 2 IgA (HSV2 IgA) Herpes Simplex 1,2 IgG (HSV1,2 IgG) % 98% 98% 97% 99.2% 97.2% 75% 96% 98% 97.7% 100% 80% 99% 100% 98% 98.7% 100 % 100 % 9
10 Herpes Simplex 1,2 IgM (HSV1,2 IgM) Epstein Barr Virus VCA IgG (EBV, VCA IgG) Epstein Barr Virus VCA IgM (EBV, VCA IgM) Epstein Barr Virus VCA IgA (EBV, VCA IgA) (EBV, VCA IgA) Epstein Barr Virus Early Antigen (EA) IgG Epstein Barr Virus Nuclear Antigen (EBNA) IgG Epstein Barr Virus Nuclear Antigen (EBNA) IgM Chlamydia Trachomatis IgG Chlamydia Trachomatis IgA Chlamydia Trachomatis IgM Measles IgG Measles IgM Mumps IgG Mumps IgM Legionella G/M/A Legionella IgG/IgM H. pylori IgG H. pylori IgA H. pylori IgM / H. pylori Antigen Varicella-Zoster IgG Varicella-Zoster IgM Syphilis (TPA) IgG Syphilis (TPA) IgM % 99% ~65 min 99.4% 100 % 97.4% 96.4% ~90 min 100% 100 % ~60 min 97.8% 100% ~90 min 100% 94.5% 96.1% 98.5% 100% 94% 99% 99% 99.3% 96.6% ~70 min 92.3% 95% ~65 min 90.55% 98% 99% 97% 89.9% 97% 98.% 98% 0.5 ng/ml N/A 99.4% 97% ~50 min 100% 100% ~154 min 100% 100% ~85 min 95% 95% Syphilis (TPA) IgG/IgM ~70 min N/A N/A Lyme Disease IgG (Borrelia burgdorferi IgG) Lyme Disease IgM (Borrelia burgdorferi IgM) ~70 min 91.7% 96.4% ~70 min 95.5% 92.5% 10
11 Lyme Disease IgG/IgM (Borrelia burgdorferi IgG,IgM) Mycoplasma Pneumoniae IgG Mycoplasma Pneumoniae IgM Brucella IgG Brucella IgM Brucella IgA HBsAg HBsAg Ultra-Sensitive HBsAb / ~70 min 92% 95% ~60 min 87.5% 95.% ~60 min 100% 93% ~110 min 100% 100% ~110 min 100% 100% ~110 min 100% 100% 99.9% 99.75% ~120 min 100% 99.78% 100% 99.7% HbsAb ~ 75 min 5mIU/ml 99% HBcAb % 82% HBcAb IgM % 99.3% HBeAg % 99% HBeAb % 99.7% HDV IgG HDV IgM HDV Ag HEV IgG % 93.8% HEV IgM % 100% HEV Ab % 99.6% HCV Ab % 96% HCV IgM % 99% HAV IgG HAV IgM % 99% HIV 1/ % 99.89% HIV 1/2 Ab/Ag ~105 min 100% 100% HTLV ~90 min 100% 99.99% 11
12 / AccuDiag Parasitology Antibody Detection Cysticercosis IgG (T.Solium) E. histolytica IgG (Amebiasis) Echinococcus IgG ~15min 98.4% 100% ~15 min 100% 100% ~15 min 100% 100% Leishmania ~30 min 97% 84% Fasciola IgG ~15 min 100% 100% Schistosoma IgG ~15 min 100% 100% Strongyloides IgG ~15 min 100% 100% Chagas ~30 min 96% 97% Scrub typhus IgG ~110 min N/A N/A Scrub typhus IgM N/A N/A Leptospira IgG ~15 min 100% 100% Leptospira IgM ~15 min 100% 100% Leptospira IgG & IgM ~15 min 100% 100% Toxocara IgG ~15 min 100% 100% Trichinella IgG Ascaris IgG (New) ~15 min 100% 100% ~15 min 98% 100% 12
13 / AccuDiag Parasitology Antigen Detection Cryptosporidium (Fecal) ~100 min 100% 100% E. Coli 0157 (Fecal) ~100 min 92% 100% E. histolytica/dispar ~88 min 88% 100% E. Coli Verotoxin (Fecal) ~100 min 100% 99% Giardia ~100 min 100% 100% Crypto/Giardia Ag Combo ~100 min 99% 100% Legionella Urinary Antigen ~100 min 95% 100% Campylobacter (Fecal) ~50 min 77% 100% AccuDiag Diabetes and Pancreatic Disease Assay Insulin ~45 min 1.5 µiu/ml N/A C-Peptide ~135 min ng/ml 100% Leptin ~190 min 0.3 ng/ml N/A 13
14 / AccuDiag FOOD Deoxynivalenol (DON) (New) ~ 60 min. 0.5 ng/ml N/A Zearalenone (New) ~ 200 min ng/ml N/A T2-Toxin (New) ~ 20 min ppb N/A Vitamin H (Biotin) ~90 min 0.5 ng/ml 98% Vitamin B ~80 min 0.3 ng/ml 98% Folate (Folic Acid) ~140 min 2 ng/ml 100% Campylobacter Antigen Detection E. Coli 0157 Antigen Detection Salmonella Antigen Detection Verotoxin Antigen Detection Egg White Protein ~50 min N/A N/A ~70 min N/A N/A ~50 min N/A N/A ~100 min N/A N/A ~60 min 0.05 ppm N/A Beta-Lactoglobulin (Milk Protein) ~60 min 1.5 ppm N/A Soy Protein ~60 min 16 ppb 100% Aflatoxin B ~140 min 10 pg/ml N/A Aflatoxin M ~140 min 3 pg/ml N/A Fumonisin ~80 min 0.5ng/mL N/A Chloramphenicol ~60 min 0.03 ng/ml N/A Penicillin ~140 min 3 ng/ml N/A Streptomycin ~60 min 1 ng/ml N/A Histamine ~60 min 3 ng/ml N/A Almond ~60 min 0.25 ng/ml N/A Gluten / Gliadin ~110 min 0.3 ppm N/A Hazelnut Lupine ~60 min 0.33 ppm 100% ~60 min 0.2 ppm N/A 14
15 Mustard Peanut Walnut / ~60 min 1 ppm N/A ~60 min 0.1 ppm N/A ~60 min 0.35 ppm N/A Other Miscellaneous Anti-Tetanus Toxoid ~90 min IU/mL Diphtheria Toxoid IgG ~90 min IU/mL 97% 97% 15
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