Calibration module for determining biological age

Abstract

This utility model relates to in vitro diagnostics and molecular biology, including calibration tools for quantitative PCR methods for determining relative telomere length (T / S index) and validating the suitability of pre-analytical assay conditions. The objective of the utility model is to develop a single calibration module that simultaneously constructs a calibration curve for the T / S index and objectively verifies the suitability of pre-analytical conditions using an irreversible temperature indicator integrated into the packaging / cassette. The technical result is reproducible and traceable T / S calibration, a reduced risk of systematic error due to disruption of the calibrator cold chain, a reduction in the time and number of operations due to the integration of calibrations and pre-analytical control in a single module, and increased comparability of results between batches and sites.The calibration module comprises a polymer cassette body measuring, for example, 120 x 80 mm, containing six wells with a volume of 0.2 ml each. The wells are hermetically sealed with a membrane. The wells contain lyophilized DNA standards 4 with nominal T / S values ​​of 0.70; 0.90; 1.00; 1.20; 1.40; 1.60. A temperature-sensitive indicator 6 is attached to the outer surface of the cassette body; it changes color when the permissible storage temperature threshold is exceeded. A QR code forming the batch identifier is applied to the cassette body. Container 5 with 1.0 ml of recovery buffer is supplied in the kit. The indicator is visually inspected before use. While maintaining the original color, reconstitution buffer is added to each well 2, lyophilized standards are dissolved, and then used to calibrate the qPCR / MMqPCR assay for determining the T / S index. If the indicator color changes, the module is not used.

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