EMA and EP Virus Testing
VIEW TECHNICAL LIBRARYOVERVIEW:
Validated assays for detection of adventitious viruses and neutralizing antibodies in bovine serum and other bovine materials.
MATERIALS TESTED:
Serum
Supplements
SPECIES:
BOVINE
PORCINE
FULL DESCRIPTION:
Validated assays for detection of adventitious viruses and neutralizing antibodies in bovine serum and other bovine materials.
Several guidance documents from committees of the EMA (European Medicines Agency) as well as European Pharmacopeia (EP) monographs govern testing of bovine serum and bovine origin materials used in manufacture of both human and veterinary medicinal products. VMRD has designed several validated assays to address these requirements.
Viruses Detected by FA:
- Bluetongue Virus (BTV)
- Bovine Adenovirus (BAV)
- Bovine Leukemia Virus (BLV)
- Bovine Parvovirus (BPV)
- Bovine Respiratory Syncytial Virus (BRSV)
- Bovine Viral Diarrhea Virus (BVDV)
- Equine Herpesvirus (EHV)
- Equine Arteritis Virus (EAV)
- Porcine Adeneovirus (PAV)
- Porcine Hemagglutinating Encephalomyelitis (PHEV)
- Porcine Parvovirus (PPV)
- Reovirus (REO)
- Rabies Virus (RAB)
- Transmissible Gastroenteritis Virus (TGE)
Optional Viruses Detected by FA:
- Bovine Parainfluenza Virus Type 3 (PI-3)
- Equine Infectious Anemia (EIA)
- Infectious Bovine Rhinotracheitis (IBR/BHV-1)
- Porcine Circovirus Type 1 (PCV-1)
- Porcine Circovirus Type 2 (PCV-2)
- Porcine Influenza Virus (PIV)
- Porcine Respiratory Corona Virus (PRCV)
- Pseudorabies (PRV)
- Vesicular Stomatitis Virus (VSV)
Optional Viruses Detected by FA and Giemsa stain:
- Infectious Bovine Rhinotracheitis (IBR/BHV-1)
- Bovine Parainfluenza Virus Type 3 (PI-3)
- Porcine Parvovirs (PPV)
For testing on other origin species or for other viruses, please inquire.
AVAILABLE TESTS
-
Assay ID
ALPHA-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied CVMP 4.3.3.3; CHMP 7.3.4 -
Samples
Required 2 ml - Turnaround 7-14
-
Assay ID
EM-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied EP 5.2.5; CVMP 4.3.3.1,2; CHMP 7.3.1,2,3 -
Samples
Required 80 ml - Turnaround 25-32
-
Assay ID
EM-AOP-POR
-
Materials
Tested Serum -
Regulations
Satisfied EP 5.2.5 -
Samples
Required 80 - Turnaround 25-32
-
Assay ID
EMCT-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied CPMP/BWP/1793/02 (2003) 5.3.4 -
Samples
Required 2 ml - Turnaround 31-38
-
Assay ID
MEM-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied Partially compliant with EP 5.2.5; CVMP 4.3.3.1,2; CHMP 7.3. -
Samples
Required 80 ml - Turnaround 25-32
-
Assay ID
QUANT-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied CVMP 4.3.3.2, CHMP 7.3.3 -
Samples
Required 25 - Turnaround 7-13
-
Assay ID
SN-AOP-BOV-2
-
Materials
Tested Serum -
Regulations
Satisfied CVMP 4.3.3.3 CHMP 7.3.4 -
Samples
Required 2 ml - Turnaround 7-13
-
Assay ID
VR-AOP-BOV
-
Materials
Tested Serum -
Regulations
Satisfied NA -
Samples
Required 1 ml - Turnaround 7-13
Contact Us
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