Mycoplasma Testing
VMRD offers mycoplasma assays to satisfy various regulations, including: USDA-APHIS 9 CFR (9 CFR 113.52c, 113.53a using methods described in 113.28); European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA); United States Pharmacopeia (USP 63).
Each assay has been validated or verified to provide the best possible sensitivity for the detection of Mollicutes in your test article.
VMRD offers Bacteria and Fungi testing methods to satisfy USDA-APHIS 9CFR 113.26 for Animal Origin Products. Assay meets 113.25 requirements.
Mycoplasma Detection Assay
Assay Length:
28 days
Catalog Number:
9C-MY
Regulations Satisfied:
9 CFR 113.28, 113.52(c), 113.53(a)
Volume Required:
10 mL, 1 gram, 6 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. hyorhinis
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
9C-MY-IN
Regulations Satisfied:
9 CFR 113.28, 113.52(c), 113.53(a)
Volume Required:
10 mL, 1 gram, 6 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. hyorhinis
Mycoplasma Detection Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-DIR
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
35 mL, 5 grams, 35 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. gallisepticum, M. fermentans, M. hyorhinis, M. orale, M. pneumoniae and M. synoviae
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-IN-DIR
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
75 mL, 5 grams, 75 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-IN-IND
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
10 mL, 1 gram, 10 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay
Assay Length:
14 days
Catalog Number:
EPUSP-MY-IND
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
5 mL, 1 gram, 5 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay, Large Volume Barile Method
Assay Length:
28 days
Catalog Number:
LVB-MY-B&A
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Mycoplasma Detection Assay, Large Volume Barile Method w/inhibition
Assay Length:
28 days
Catalog Number:
LVB-MY-B&A-IN
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Mycoplasma Detection Assay, Large Volume Barile Method Indicator Cell
Assay Length:
14 days
Catalog Number:
LVB-MY-IND
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Performance Testing of Trypsin Sample
Assay Length:
1
Catalog Number:
PERF-TRYP
Regulations Satisfied:
NA
Volume Required:
NA
Materials Tested:
Porcine Trypsin
Pathogens Tested:
NA
Mycoplasma Detection Assay, FDA Points to Consider, Complete
Assay Length:
28 days
Catalog Number:
PTC-MY
Regulations Satisfied:
PTC (1993) Agar and Broth Media Procedure (Part A), and Indicator Cell Culture Procedure (Part B)
Volume Required:
40 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumoniae, M.hyorhinis, M. orale
Mycoplasma Detection Assay, FDA PTC Agar & Broth Procedure
Assay Length:
28 days
Catalog Number:
PTC-MY-B&A
Regulations Satisfied:
PTC (1993) Agar and Broth Media Procedure (Part A),
Volume Required:
30 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumoniae, M. orale
Mycoplasma Detection Assay, FDA PTC Agar & Broth w/ inhibition
Assay Length:
28 days
Catalog Number:
PTC-MY-B&A-IN
Regulations Satisfied:
Not Required
Volume Required:
80 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumonia, M. orale
Mycoplasma Detection Assay, FDA PTC Indicator Cell
Assay Length:
7 days
Catalog Number:
PTC-MY-IND
Regulations Satisfied:
PTC (1993) Indicator Cell Culture Procedure (Part B)
Volume Required:
10 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay, FDA PTC for Viruses w/ Inhibition
Assay Length:
7 days
Catalog Number:
PTC-MY-IND-IN
Regulations Satisfied:
PTC (1993) Indicator Cell Culture Procedure (Part B)
Volume Required:
20 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. hyorhinis, M. orale