GB/T 47026-2026Performance measurement method for rapid nucleic acid detection instruments (English PDF)

3.1

It integrates the entire process from sample processing to amplification and detection, and has nucleic acid extraction capabilities, or achieves nucleic acid release through chemical or other methods.

This is a nucleic acid testing device designed to meet the needs of rapid and automated testing, with a total testing time of less than 1 hour.

3.2 Ct value Cyclethreshold value

The number of cycles required for the fluorescence signal in each polymerase chain reaction (PCR) tube to reach a set threshold.

[Source. GB/T 42753-2023, 3.2]

3.3 Thermostatic process

The average temperature of the instrument orifice reaches the set value (within ±0.5°C deviation) and remains at that temperature for a period of time.

[Source. GB/T 42753-2023, 3.3]

3.4

The temperature change range of the orifice during the constant temperature phase of the instrument.

[Source. GB/T 42753-2023, 3.4]

3.5

During the instrument's constant temperature phase, the temperature consistency among the various well sites is maintained.

[Source. GB/T 42753-2023, 3.5]

3.6

Consistency of repeated fluorescence intensity measurements at instrument wells under the same temperature and fluorescence conditions.

[Source. GB/T 42753-2023, 3.6]

3.7

Under the same temperature and fluorescence conditions, the consistency of fluorescence intensity detection values among different wells of the instrument.