Infectious Diseases ELISA

Measles IgM | CHT-MVMK11 | Gentaur

Measles IgG | CHT-MVGK10 | Gentaur

Malaria screen | CHT-MLSK37 | Gentaur

Anti-HBs | CHT-G4SBE3 | Gentaur

Confirmatory HbsAg test | CHT-G4SA0 | Gentaur

Anti-HBc Total | CHT-G4CBE3 | Gentaur

HBeAg/Anti-Hbe | CHT-G4BNE3 | Gentaur

Anti-HAV IgM | CHT-G4AME3 | Gentaur

Anti-HAV | CHT-G4AGE3 | Gentaur

H.Pylori IgA | CHT-DHPA | Gentaur

H.Pylori IgG | CHT-DHPG | Gentaur

HCV Ab | CHT-G4NAE3 | Gentaur

HbsAg | CHT-G4SGE3 | Gentaur

HIV Ag/Ab 4th gen | CHT-81311/ CHT-81312/ CHT-81315 | Gentaur

AccuDiag™ Salmonella typhi IgM | 6151-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 50 min Sensitivity/ Specificity: N/A

AccuDiag™ Salmonella typhi IgG | 6150-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 50 min Sensitivity/ Specificity: N/A

AccuDiag™ Syphilis (Anti-TP) IgG/IgM MOQ is 40 kits or longer lead time | 1465-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: N/A / 100%

AccuDiag™ Syphilis (TPA) IgM | 1464-6 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 135 min Sensitivity/ Specificity: 95 /95%

AccuDiag™ Syphilis (TPA) IgG | 1463-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 180 min Sensitivity/ Specificity: 100 /100%

AccuDiag™ HTLV 1 + 2 MOQ is 40 kits or longer lead time | 8196-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 120 min Sensitivity/ Specificity: 100 / 99.99 %

AccuDiag™ HIV 1/2 Ab/Ag MOQ is 40 kits or longer lead time | 1520-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 135 min Sensitivity/ Specificity: 100 /100 %

AccuDiag™ HIV 1/2 | 1516-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: 99.95 / 99.89%

AccuDiag™ HAV IgM | 1718-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100 / 99 %

AccuDiag™ HAV IgG | 1519-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 100%

AccuDiag™ HCV Ab | 1707-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 99.55 %

AccuDiag™ HEV IgM MOQ is 40 kits or longer lead time | 1876-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 110 min Sensitivity/ Specificity: 97.1 / 100 %

AccuDiag™ HEV IgG MOQ is 40 kits or longer lead time | 1888-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 100 min Sensitivity/ Specificity: 93.8 / 85.4 %

AccuDiag™ HBeAb MOQ is 40 kits or longer lead time | 1706-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 979.7 %

AccuDiag™ HBeAg MOQ is 40 kits or longer lead time | 1705-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 95%

AccuDiag™ HBcAb IgM MOQ is 40 kits or longer lead time | 1778-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 98.4 /99.3%

AccuDiag™ HBcAb | 1704-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 99.92 / 99.82%

AccuDiag™ HBsAb | 1702-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100 / 99.70 %

AccuDiag™ HBsAg | 1701-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 85 min Sensitivity/ Specificity: 99.9 / 99.75%

AccuDiag™ SCov-2 IgM | 1500-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 111 min Sensitivity/ Specificity: See insert

AccuDiag™ SCov-2 IgG | 1501-25 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 111 min Sensitivity/ Specificity: See insert

AccuDiag™ Parvovirus B19 IgM | 1451-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: See insert

AccuDiag™ Parvovirus B19 IgG | 1450-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: 5-7 IU/mL/100%

AccuDiag™ Brucella IgM New | 1502-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: IVD Detection Type: Quantitative Assay Time: ~50 min Sensitivity/ Specificity: See insert

AccuDiag™ Brucella IgG New | 1501-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: IVD Detection Type: Quantitative Assay Time: ~50 min Sensitivity/ Specificity: 99 %/99 %

AccuDiag™ Mycoplasma pneumoniae IgM | 8043-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 100 / 93 %

AccuDiag™ Mycoplasma pneumoniae IgM | 8043-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Semi- Quantitative Assay Time: 65 min Sensitivity/ Specificity: See insert

AccuDiag™ Mycoplasma pneumoniae IgG | 8042-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Semi- Quantitative Assay Time: 65 min Sensitivity/ Specificity: See insert

AccuDiag™ Mycoplasma pneumoniae IgG | 8042-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 95 / 87.5 %

AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM | 1427-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 95 min Sensitivity/ Specificity: See Insert

AccuDiag™ Lyme Disease IgG/IgM (B. burgdorferi IgG, IgM) | 1423-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 92 / 95 %

AccuDiag™ Lyme Disease IgG/IgM (B. burgdorferi IgG, IgM) | 1423-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: See insert

AccuDiag™ Lyme Disease IgM (B. burgdorferi IgM) | 1424-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 95.5 / 92.5 %

AccuDiag™ Lyme Disease IgG (B. burgdorferi IgG) | 1428-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 100 min Sensitivity/ Specificity: 91.7 /96.4 %

AccuDiag™ Varicella-Zoster IgM | 1413-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 50 min Sensitivity/ Specificity: 100 /100%

AccuDiag™ Varicella-Zoster IgG | 1412-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 99.4 / 97%

AccuDiag™ H. pylori Antigen | 1506-12 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: N/A Sensitivity/ Specificity: See insert

AccuDiag™ H. pylori Antigen | 1506-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 0.5 ng/ml / N/A

AccuDiag™ H. pylori IgM | 1504-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 98 / 98%

AccuDiag™ H. pylori IgA | 1505-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 88.9 / 97.10%

AccuDiag™ H. pylori IgG | 1503-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: 95% / 100%

AccuDiag™ Legionella IgG/IgM | 1652-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 90 / 98%

AccuDiag™ Legionella Total (IgG/M/A) | 1651-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 105 min Sensitivity/ Specificity: 92.3 / 93.1%

AccuDiag™ Mumps IgM | 1411-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100 / 100%

AccuDiag™ Mumps IgG | 1410-47 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 60 min Sensitivity/ Specificity: See Insert

AccuDiag™ Mumps IgG | 1410-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 99.3 /96.6%

AccuDiag™ Measles IgM | 1409-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 93/93%

AccuDiag™ Measles IgG | 1408-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Quantitative Assay Time: 75 min Sensitivity/ Specificity: 99.3 / 91 %

AccuDiag™ Chlamydia Trachomatis IgM | 1427-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 99/99%

AccuDiag™ Chlamydia Trachomatis IgA | 1417-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/94%

AccuDiag™ Chlamydia Trachomatis IgG | 1407-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 96.1/98.5%

AccuDiag™ Epstein-Barr Virus Nuclear Antigen (EBNA) IgM | 1426-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: See insert

AccuDiag™ Epstein-Barr Virus Nuclear Antigen (EBNA) IgM | 1426-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 135 min Sensitivity/ Specificity: 100/94.5 %

AccuDiag™ Epstein-Barr Virus Nuclear Antigen (EBNA) IgG | 1425-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Semi- Quantitative Assay Time: 75 min Sensitivity/ Specificity: 97.8/ 100%

AccuDiag™ Epstein-Barr Virus Early Antigen (EA) IgM | 1418-16 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/ 100%

AccuDiag™ Epstein-Barr Virus Early Antigen (EA) IgG | 1415-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 92% / 81%

AccuDiag™ Epstein-Barr Virus Early Antigen (EA) IgG | 1415-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: See insert

AccuDiag™ Epstein-Barr Virus VCA IgM (EBV, VCA IgM) | 1406-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: 90.9% / 93.2%

AccuDiag™ Epstein-Barr Virus VCA IgM (EBV, VCA IgM) | 1406-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: See insert

AccuDiag™ Epstein-Barr Virus VCA IgA EBV, VCA IgA) (EBV, VCA IgA) | 1414-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/ 100%

AccuDiag™ Epstein-Barr Virus VCA IgG (EBV, VCA IgG) | 1405-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: 98.1% / 98.3%

AccuDiag™ Epstein-Barr Viral Capsid Antigen (P-18) IgG | 1405-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: 95% (sero+) /100%

AccuDiag™ Herpes Simplex 1, 2 IgM (HSV1, 2 IgM) | 1444-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: 75% / 90.3%

AccuDiag™ Herpes Simplex 1, 2 IgG (HSV1, 2 IgG) | 1443-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/ 100%

AccuDiag™ AccuDiag™ Herpes Simplex 2 IgA (HSV2 IgA) | 1399-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 98 / 98.7%

AccuDiag™ Herpes Simplex 2 IgM (HSV2 IgM) | 1404-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 99/100%

AccuDiag™ Herpes Simplex 2 IgG (HSV2 IgG) | 1403-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/98%

AccuDiag™ Herpes Simplex 1 IgA (HSV1 IgA) | 1400-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: 98 / 98.7%

AccuDiag™ Herpes Simplex 1 IgM (HSV1 IgM) | 1402-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 75 / 96%

AccuDiag™ Herpes Simplex 1 IgG (HSV1 IgG) | 1401-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/ 100%

AccuDiag™ Herpes Simplex 1 IgG (HSV1 IgG) | 1401-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: Yes IVD: IVD Detection Type: Qualitative Assay Time: N/A Sensitivity/ Specificity: See insert

AccuDiag™ Cytomegalovirus IgA (CMV IgA) | 1200-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 99.2 / 97.2%

AccuDiag™ Cytomegalovirus IgM (CMV IgM) | 1202-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 70 min Sensitivity/ Specificity: 92.5 / 98.5%

AccuDiag™ Cytomegalovirus IgG (CMV IgG) | 1201-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 70 min Sensitivity/ Specificity: 96.4 / 93.9%

AccuDiag™ Cytomegalovirus IgG (CMV IgG) | 1201-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: IVD Detection Type: Semi- Quantitative Assay Time: 65 min Sensitivity/ Specificity: N/A

AccuDiag™ Rubella IgA | 1300-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 100/ 99.2%

AccuDiag™ Rubella IgM | 1302-18 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 90 min Sensitivity/ Specificity: 100% / 99.2%

AccuDiag™ Rubella IgM | 1302-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 60 min Sensitivity/ Specificity: 100% / 97.2%

AccuDiag™ Rubella IgG | 1301-2 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative/ Quantitative Assay Time: 95 min Sensitivity/ Specificity: 100% / 100%

AccuDiag™ Rubella IgG | 1301-1 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: IVD Detection Type: Qualitative Assay Time: 65 min Sensitivity/ Specificity: N/A

AccuDiag™ Toxoplasma IgA | 1103-11 | Diagnostic Automation/Cortez Diagnostics Inc CE: N/A IVD: In-Vitro Detection Type: Qualitative Assay Time: 75 min Sensitivity/ Specificity: 94 / 100%