PCR validation tubes
AssigneeStarna Scientific Limited
InventorsKeith Hulme, Nathan Hulme, John Hammond
Life of this patent
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Abstract
This invention relates to a PCR fluorescence reference standard and to a method for manufacturing a PCR fluorescence reference standard. The PCR fluorescence reference standard comprises a fluorophore suspended in a thermoplastic polymer matrix. The PCR fluorescence reference standard of the invention has a greater shelf life than fluorophores dissolved in a solution and can advantageously be used to validate a fluorescence signal obtained in a thermal cycler.
Claims14
A method of validating a thermal cycler comprising the steps of:
- (a) providing a fluorophore suspended in a thermoplastic polymer matrix selected from the group consisting of:
- poly methyl methacrylate (PMMA), polycarbonate (PC), poly oxymethylene (POM), chlorinated polyvinyl chloride (CPVC) or PVC/Acrylic copolymer, the fluorophore characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides for each of the one or more specified properties, the value of the specified property, its associated uncertainty, and a statement of metrological traceability, and the thermoplastic polymer matrix is cut to the shape of a PCR tube;
- (b) placing the fluorophore suspended in a thermoplastic polymer matrix of step (a) in a thermal cycler having means to measure fluorescence;
- and
- (c) validating a fluorescence measurement obtained in the thermal cycler of step (b) by using the fluorophore suspended in a thermoplastic polymer matrix of step (a);
- wherein validating the fluorescence measurement obtained in the thermal cycler includes confirming by examination and the provision of objective evidence that the fluorescence measurement obtained in the thermal cycler matches the one or more specified properties of the fluorophore within the associated uncertainty.
A method of validating a thermal cycler, comprising the steps of:
- suspending a fluorophore in a thermoplastic polymer matrix, wherein the fluorophore has fluorescence characteristics within a predetermined uncertainty budget, and wherein the polymer matrix is selected from the group consisting of:
- poly methyl methacrylate (PMMA), polycarbonate (PC), poly oxymethylene (POM), chlorinated polyvinyl chloride (CPVC) or PVC/Acrylic copolymer, and the thermoplastic polymer matrix is cut to the shape of a PCR tube;
- and
- validating the thermal cycler using measurements obtained in the thermal cycler and the predetermined uncertainty budget of the fluorophore;
- wherein validating the thermal cycler includes confirming by examination and the provision of objective evidence that the measurements obtained in the thermal cycler match the fluorescence characteristics of the fluorophore within the predetermined uncertainty budget.
A method of operating a thermal cycler comprising the steps of:
- (a) providing a reference standard cut to the shape of a PCR tube, the reference standard including a fluorophore suspended in a thermoplastic polymer matrix selected from the group consisting of:
- poly methyl methacrylate (PMMA), polycarbonate (PC), poly oxymethylene (POM), chlorinated polyvinyl chloride (CPVC) or PVC/Acrylic copolymer, the reference standard having predetermined values of fluorescent intensity and spectral correction within a predetermined uncertainty budget;
- (b) placing the reference standard of step (a) in a thermal cycler having means to measure fluorescence;
- and
- (c) validating a fluorescence measurement obtained in the thermal cycler of step (b) by comparing a measured fluorescent intensity and spectral correction of the reference standard of step (a) to the predetermined values of fluorescent intensity and spectral correction for the reference standard.
Dependencies are inferred from the claim text.