FDA GLP Quality Human Cell Line Genotyping Overview

SeqWright’s GLP compliant human cell lines genotypic characterization service offers rapid and accurate cell line identification by analyzing a pattern of defined short tandem repeats (STR). STR’s are a class of DNA polymorphisms that occurs when two or more nucleotides are repeated contiguously, typically in non-coding intron regions. By counting the number of repeats in specific STR sequences at defined loci, it is possible to determine the unique genetic profile of a sample.

Human Cell Line Genotyping Service Features

DNA fingerprinting with the Applied Biosystems AmpFl STR® Identifiler PCR Amplification Kit.
- Same system used by the American Type Tissue Collection (ATCC) for its STR database of human cell lines.
- Only small amounts of human DNA required.
- Fingerprinting of 15 STR loci and the amelogenin gene.
- Discrimination of less than 1 in 108 individuals*.
- Markers directly comparable to the ATCC STR Database.
Cell line contamination detection by the presence of 3 or more alleles.
Analysis by GeneMapper® ID Software.
Nucleic acid extraction included.
LIMS sample tracking
GLP-compliant sample and data handling
- 21 CFR 58 compliant (GLP).
- 21 CFR 11 compliant (Electronic Signatures).
- CLIA certified.

Plot

Marker	Allele 1	Allele 2
Amelogenin	X	Y
CSF1PO	10	11
D13S317	9	13
D16S539	12	13
D18S51	12	13
D19S433	12	15
D21S11	23	31.2
D2S1338	16	19
D3S1358	16	18
D5S818	8	12
D7S820	10	11
D8S1179	11	12
FGA	21	22
TH01	9	9.3
TPOX	8	9
VWA	16	19

*(Lins, A.M., et al. J. Forensic Sci. 43: 1168-1180, 1998)

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