8
1. General Information
1.1. Intended Use and modifications of the instrument
The “DTprime” real time PCR instrument is intended for carrying out an assay using
polymerase chain reaction (PCR) method and accumulated product detection in a real time
(real-time PCR). Detection of the accumulated PCR amplification product occurs directly
during the execution of the amplification program, which increases the informative value of
the study.
The field of application - clinical laboratory diagnostics in vitro;
Purpose of use – diagnostics;
Sample type - samples of human DNA and microorganisms extracted from samples of
biomaterial;
The instrument is manufacturing in the following modifications: 2М1, 2М3, 2М6, 4M1, 4М6,
5M1, 5M3, 5M6, 6М6, 2Х1 4X1, 5X1, 6Х1.
Modification of the instrument is defined by the following structure – XXX, where:
1) 1st X is figure from 4 to 5 and it indicates the number of optical detection channels;
2) 2nd X is the symbol M or X and it determines the thermal block format: M - 96 wells of
200
l, X - 384 wells of 45
l.
3) 3rd X is figure 1, 3 or 6 and it means a thermal block version such as 1 – monoblock; 3 or
6 - the number of thermal block sections.
The instrument is designed for simultaneous analysis of up to 96 or up to 384 samples
depending on the modification (M or X).
Preparation and initialization of experiments on the instrument is realized with an IBM-
compatible personal computer, and further implementation of a preset program may be
executed autonomously. On completing the amplification program, the instrument goes to the
storage mode, and if the option “
Turn off device after the run
” is activated on the window
“
Running
”, the instrument goes to the power standby mode.
The optical measurements results may preliminarily be evaluated during the execution of the
amplification program, whereas the final evaluation – at any time after completing the
program. All data of the last amplification are saved in the internal memory of the instrument
and may be read out even in the case of power failure during amplification. As soon as the
mains supply is restored, the instrument continues to function with full recovery of the
amplification program status. Neither failure of the operating system, nor disconnection of the
external computer will halt the experiment. Thus, the instrument is highly protected against
major factors effect, which may result in a failure during PCR implementation.
One computer may control operation of several instruments, including ones of different types
(DTlite, DTprime) connected to it via USB ports.
To operate the instrument, the RealTime_PCR software is used, which allows performing the
following operations:
Test creation and editing;
Plate protocol creation;
Checking geometrical and optical settings of the device;