7
1.
General Information
1.1 Intended Use and modifications of the instrument
The “DTlite” 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 ex-
ecution 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 bio-
material;
The instrument is manufacturing in the following modifications: 4S1, 4S2, 5S1, 5S2, 6S1,
6S2, 4L1, 5L1, 6L1.
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 S or L, which determines the thermal block format: S - 48 wells of
200
l, L - 384 wells of 45
l.
3) 3rd X is figure 1, or 2 means a thermal block version such as 1 – monoblock; 2 - the num-
ber of thermal block sections.
The instrument is designed for simultaneous analysis of up to 48 or up to 192 samples de-
pending on the modification (S or L).
Preparation and initialization of experiments on the instrument is realized with an IBM- com-
patible 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 “
Run-
ning
”, 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 pro-
gram. 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 fac-
tors 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;
Creation, launching, and monitoring of the amplification program;
Monitoring the execution of the amplification program
Analysis of optical measurements data.
Data analysis report.
Settings and diagnostics of the instrument.
Loading and unloading of analyzed samples may be automatic in case if the instrument is
built in a robotic system.
