Mycoplasma Testing

VMRD offers mycoplasma assays to satisfy various regulations, including:

  • USDA-APHIS 9CFR (9CFR 113.53a and 113.28)
  • European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA) 
  • United States Pharmacopeia (USP <63>)

Additionally:

  • Large Volume Barile method mycoplasma detection assay (broth and agar method)
  • Large Volume Barile method mycoplasma detection assay (indirect culture on indicator cells)

Materials Tested

Animal Origin Products​

Cell Lines

Virus Seeds

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Available tests - All Species

Catalog ID
9C-MY-IN
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
*9CFR 113.52c,113.53a
Samples
Needed
10 ml/1 g/6 x 1 ml aliquots
Turn-Around
Time (Days)
31-38
9C-MY-INMycoplasma detection assay using direct culture in compliance with 9CFR 113.52c, 113.53a using methods described in 113.28, also including an assay to detect inhibition of the growth of mycoplasmas by the test materials.
Catalog ID
9C-MY
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
9CFR 113.52c,113.53a
Samples
Needed
10 ml/1 g/2 x 1 ml aliquots
Turn-Around
Time (Days)
31-38
9C-MYMycoplasma Detection Assay using direct culture in compliance with 9CFR 113.52c, 113.53a using methods described in 113.28.
Catalog ID
EPUSP-MY-DIR
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
EP 2.6.7, USP 63
Samples
Needed
35 ml/5 g/35 X 1 ml aliquots
Turn-Around
Time (Days)
31-38
EPUSP-MY-DIRMycoplasma Detection Assay in compliance with EP 2.6.7 and USP 63 without inhibition-Direct culture.
Catalog ID
EPUSP-MY-IND
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
EP 2.6.7 and USP 63
Samples
Needed
5 ml/1 g/5 X 1 ml aliquots
Turn-Around
Time (Days)
14-21
EPUSP-MY-INDMycoplasma Detection Assay in compliance with EP 2.6.7 and USP 63. Indicator cell culture method (DNA stain).
Catalog ID
EPUSP-MY-IN-DIR
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
EP 2.6.7 and USP 63
Samples
Needed
75 ml/5 g/75 X 1 ml aliquots
Turn-Around
Time (Days)
31-38
EPUSP-MY-IN-DIRMycoplasma Detection Assay in compliance with EP 2.6.7 and USP 63 with inhibition-Direct culture.
Catalog ID
EPUSP-MY-IN-IND
Materials Tested
Serum,powder,cell lines/stocks,virus banks/lots
Regulations Satisfied
EP 2.6.7 and USP 63
Samples
Needed
10 ml/1 g/10 X 1 ml aliquots
Turn-Around
Time (Days)
31-38
EPUSP-MY-IN-INDMycoplasma detection assay, Large Volume Barile Method-indirect culture on indicator cells.
Catalog ID
LVB-MY-B&A
Materials Tested
Serum products
Regulations Satisfied
N/A
Samples
Needed
100ml/10g
Turn-Around
Time (Days)
28
LVB-MY-B&AMycoplasma detection assay, Large Volume Barile Method-direct culture.
Catalog ID
LVB-MY-IND
Materials Tested
Serum products
Regulations Satisfied
N/A
Samples
Needed
100ml/10g
Turn-Around
Time (Days)
14
LVB-MY-INDMycoplasma detection assay, Large Volume Barile Method-indirect culture on indicator cells.

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