StaRT-PCR gene assay products are designed and developed under the FDA Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and in compliance with Gene Express' defined and tested SOPs (Standardized Operation Procedures). The 29-step assay development process is highly quality controlled (QC) and quality assurance (QA). (See QC/QA White Paper)

StaRT-PCR assays are precisely designed, with controlled manufacturing of reagents and rigorous assay protocols which yield high quality StaRT-PCR multi-gene Transcript Abundance Measurements. This high quality is the result of rigorous manufacturing practices for the component reagents and strict adherence to Standard Operating Procedures (SOPs) in our production facility and the SEM Center. This requires the employment of stringent quality control (QC) and quality assurance (QA) measures throughout the development process. The quality control and quality assurance processes involved in the design and manufacture of StaRT-PCR assays and reagents are described in a technical white paper.

The reagents used in StaRT-PCR are manufactured with stringent quality control and quality assurance. The end result is the highest quality transcript abundance data in the industry today. The standardized data that is obtained is not only critical for application to diagnostics and drug development but will also enhance our understanding of various disease processes.

The stringent quality control (QC) and quality assurance (QA) measures are listed in the table below:

 

QA/QC steps for StaRT-PCR*** reagents
Reagent	QC/QA Test	Acceptable Specifications
Individual primer pairs	Correct sequence and amount	COA from manufacturer
	Specificity	BLAST search of primer sequence verified to be 100% correct. No hit with non-specific targets.
		Correct amplimer size verified for both internal standard and native template
		Primer sequences of internal standard verified to be 100% correct by sequence analysis
	Lack of SNP interference	Primer sequences devoid of known SNPs
	Discrimination of alternative transcripts	Primers designed to allow for differentiation of alternative transcripts
Primer stock solutions	PCR with no template	Free from Internal Standard or native template contamination
Primer stock solutions/IS*	PCR with IS only	Correct size IS amplimer
		No interfering products
Internal Standard*	Concentration of each internal standard determined by standard method	Each internal standard quantified using the Hoechst dye method with a calf thymus DNA standard
Primer stock solutions/IS*/SMIS**	Lower limit of detection	Amplimer from 60 molecules or less of template
SMIS	PCR with SMIS™ only	Correct size IS for each assay
		No native template contamination
	Functional test: StaRT-PCR™ with Universal Human RNA	Correct native template and Internal Standard amplimer produced, assay characteristics acceptable
Pipettes, hoods, fluorometer, thermocycler blocks all on a routine calibration/maintenance schedule * Internal Standard ** Standardized Mixtures of Internal Standards (SMIS). *** "StaRT-PCR" - Standardized (Sta), Reverse Transcriptase (RT), Polymerase Chain Reaction (PCR) - PCR is an enzymatic process to increase the number of copies of DNA for easier detection.