IPV - Instrument performance verification

This test is to answer the following and similar questions:

• Does the sample behave the same in all the capillaries of my sequencer or in all wells of the Real-Time PCR cycler?
• Is the intensity of the measured signal always and everywhere the same, and if not, how much does it differ? In other words, does the sample detection sensitivity depend on the sample position?
• What is the variability of the results? Does the standard deviation of the mean size of the detected allelic peaks in all capillaries of my sequencer comply with the specifications? Does my Real-Time PCR instrument reliably distinguish samples with the numbers of template copies that differ twice or less?

We will verify, after repairs or servicing, in connection with regular inspections of your instruments, or simply ad hoc, that your instruments comply with their functional specifications. This not only means that they are in good technical condition, but that they provide results that you reasonably expect and require and that may not always be achieved due to the consumables and reagents used. The tests are carried out according to the standards prescribed by the manufacturer.

The instrument performance verification (IPV) includes the following (the list is not complete):

DNA sequencers

• Instrument calibration (spatial and spectral calibration for dye sets as needed)
• General functional test carried out to verify that the instrument can distinguish peaks detected at a confidence level of 99.7% (resolution - size separation), verification of the detected peak height (detection sensitivity), verification of the length of reading (LOR)
• Protocol - After IPV, a protocol is issued for the customer containing all parameters, including any defects discovered

Real-Time PCR instruments

• Check of the optical system, calibrations if necessary
• TC check (temp verification, ramp rates for cooling & heating, sample block uniformity)
• General functional test carried out to verify that the device can distinguish samples with templates the concentration of which differs twice (or within the specifications of the manufacturer) at the confidence level of 99.7%
• Protocol - After IPV, a protocol is issued for the customer containing all parameters, including any defects discovered

---

We recommend to carry out the instrument performance verification (IPV) according to the needs of the laboratory, at least once a year, preferably in connection with the instrument inspection (preventive examination). It is also recommended to carry out these tests, e.g. after moving the instrument, in connection with repairs done, based on the requirements of your SOP, etc.