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Testing

A.

Acholeplasma
Genus belonging to the bacterial class Mollicutes.

mbsABO medium

mbsABO (for ALL-by-ONE) medium is a universal mycoplasma culture medium supporting rapid growth of all common cultivable mycoplasmas and of the highly fastidious cell culture-adapted cultivar ? strains.

mbsALPHA medium

mbsALPHA medium is a selective medium for cultivation of highly fastidious cell culture-adapted cultivar ? strains, particularly of M. hyorhinis.

ATCC

American Type Culture Collection

CFU

Colony forming unit(s)
The number of individual colonies on solid agar medium formed by single bacterial cells (e.g., mycoplasma cells). CFU values are determined for bacterial titer calculation (e.g., the total number of mycoplasma cells in mycoplasma culture reference standards).

CBER

Center for Biologics Evaluation & Research (at FDA).

Comparability study

A study to compare the results of two or more methods and to assess their similarities thereby taking into account critical parameters (e.g., comparison of NAT- and culture-based mycoplasma detection methods).

Cultivar-α strains

Cultivar-α strains are highly fastidious cell culture-adapted mycoplasma strains (particularly of M. hyorhinis) that have complex nutritional requirements and cannot be cultivated on standard mycoplasma media such as mbsFRIIS or mbsFREY media. The reference strain for cultivar-α strains is Mycoplasma hyorhinis DBS 1050. The experts from Mycoplasma Biosafety can cultivate the cultivar-α strains in mbsALPHA medium and mbsABO medium

Culture reference standard

A culture reference standard is a CFU-quantified or -calibrated preparation of highly viable organisms of a particular well-characterized type or reference field strain to be used for validation and as positive controls of culture-based testing methods. Culture reference standards with a low GC/CFU ratio are suitable for the validation of NAT-based assays and their comparison with the culture methods.

DNA

Deoxyribonucleic acid

DNA reference standard

A DNA reference standard is a DNA sample with precisely measured content of specific DNA that can be serially diluted to assess the limit of detection of an NAT-based assay or to create a standard curve used in Q-PCR to assess the concentration of target nucleic acid.

ELISA

The Enzyme-Linked Immunosorbent Assay is an immunological assay used to qualitatively or quantitatively detect antibodies or antigens in sample material (e.g., a serodiagnostic screening assay for detection of antibodies against a particular mycoplasma species in serum samples).

EMA

European Medicines Agency

Endpoint PCR

Endpoint PCR is the classical PCR method based on repeated cycling of the reaction mixture between two or three temperatures (denaturing, annealing, and extension) with detection of the amplified product after reaction completion (e.g., agarose gel electrophoresis).

EP

European Pharmacopoeia

FDA

US Food and Drug Administration

mbsFREY medium

mbsFREY medium is a standard mycoplasma medium mainly used for the cultivation of avian mycoplasmas, particularly of Mycoplasma synoviae. The medium composition is described in the mycoplasma chapters of the EP (2.6.7.) and the USP ().

mbsFRIIS medium

mbsFRIIS medium is a standard mycoplasma medium used for the cultivation of many mycoplasmas except for Mycoplasma synoviae and cultivar ? strains. The medium composition is described in the mycoplasma chapters of the EP (2.6.7.) and the USP ().

GC

Genome copy/ies
The GC number is the number of genome equivalents.

GC/CFU ratio

The relationship between the number of colony forming units counted on solid agar media (total number of bacteria based on viable counts) and the number of genome copies based on the published genome size and quantitative determination of the amount of genomic DNA.

GLP

Good laboratoory practice(s)

GMP

Good manufacturing practice(s)

JP

Japanese Pharmacopoeia

Limit test

A limit test is a qualitative test that gives a positive or negative result.

LOD

Limit of Detection
The LOD of a mycoplasma test is defined as the lowest concentration of the targeted mycoplasma species or strain that can be unambiguously detected in a sample.

M.

Mycoplasma
Genus belonging to the bacterial class Mollicutes.

mbs

Mycoplasma Biosafety Services' general code for its own products

mbsMHYO medium

mbsMHYO is a non-selective growth medium for "the 3 Mhyo" mycoplasma species, Mycoplasma hyopneumoniae, Mycoplasma hyorhinis, and Mycoplasma hyorsynoviae.

Mid-log phase

During the mid-log phase in a batch culture a bacterial population doubles at regular intervals by binary fission and is growing by geometric progression. The cells divide at a constant rate depending on the composition of the culture medium and the conditions of incubation. In this exponential growth phase, the number of total cells corresponds to the number of viable cells and to the number of genome copies.

Mollicutes

Mollicutes represent a separate taxonomic class of bacteria that lack a cell wall due to reductive evolution from certain gram-positive bacteria. The trivial name is mycoplasmas.

NAT

Nucleic acid amplification technique(s)
Mycoplasma NATs are methods for detection of mycoplasmas via detection of mycoplasma-specific nucleic acid. The most common NAT method is the PCR.

NCTC

National Collection of Type Cultures

PCR

Polymerase chain reaction
The PCR is characterized by repetition of three reaction steps: denaturing, annealing, and extension. Each step is defined by different temperatures and reaction times. Some PCR methods combine the annealing and extension steps.

PMDA

Pharmaceuticals and Medical Devices Agency, the Japanese regulatory agency

PTC 1993

Points to consider in the characterization of cell lines used to produce biologicals. Attachment 2, Recommended procedures for detection of mycoplasma contamination in biological products produced in cell substrates (FDA/CBER, 1993).

qPCR

Quantitative PCR or Real-Time PCR is a PCR method that detects and quantifies the synthesis of the target amplicon in "real-time" during PCR amplification. The quantification is given in "threshold cycles".

RAPD

Randomly amplified polymorphic DNA
RAPD analysis is a genotyping method for intra-species differentiation of mycoplasma strains or strains of other bacterial species. By this method the genetic relatedness of mycoplasma strains can be elucidated in order to trace mycoplasma outbreaks and routes of contamination during root-cause analysis.

Reference standard/s

Well-defined bacterial reference standard preparations developed as validation reference standards or positive controls to validate or to routinely monitor the performance of a testing assay. Reference standards for NAT-based assays may be presented by nucleic acid templates such as plasmids or genomic DNA or by highly viable low GC/CFU culture reference standards. Reference standards for culture methods are CFU-quantified viable bacteria.

S.

Spiroplasma
Genus belonging to the bacterial class Mollicutes.

Sample volume

Sample volume is the amount of a test article required for analysis using a particular technique/assay.

Specificity

Specificity is the ability of an analytical procedure to accurately measure a target analyte in the presence of other components in the sample matrix.

Touchdown PCR

Touchdown PCR is a technique to reduce appearance of non-specific amplicons in PCR reaction.

U.

Uraplasma
Genus belonging to the bacterial class Mollicutes

mbsUREA medium

mbsUREA medium is a selective growth medium for cultivation of mycoplasmas of the genus Ureaplasma.

USP

United States Pharmacopeia

VICH

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products

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