Validation/accreditation Studies
The validation/accreditation studies and user-survey questionnaires
referenced are thanks to
Peter van Eede, CLB Dept. of Immunology,
Amsterdam Red Cross
1-1 Validation of ABI GeneScan file import in
DNA•VIEW
Introduction
From DNA•VIEW version 21 there is an option to import ABI GeneScan files. This
option is validated in version 21.15 because in this version the
stutter filter is added. The ABI results of the multiplex systems
CTTv and FFFL (Promega) are used. The GeneScan analysis version in
use is 2.1
Protocol
The frequencies used in Pater will be imported in DNA•VIEW and
checked. The PCR parameters will be imported according to the manual.
After importing the GeneScan files from eight different sample runs
in DNA•VIEW. the results of the calculated PI value in DNA•VIEW will
be compared with the results of the same samples from the PI
calculation in Pater.
Criteria
Except for some slight round off causes there must be no differences
between the DNA•VIEW and Pater results.
Results
In the first results differences were seen between DNA•VIEW and
Pater. These differences were caused by the setting of the option
Count observed allele how many times in database. The allele
TH01 9.3 caused another problem. Sometimes there was confusion in
DNA•VIEW between TH01 9.3 and 10. Setting the option Count
observed allele how many times in database = 0 and retyping,
every TH01 9.3 allele in the membrane using the option casework,
type in a read, with the size of the fragment, no differences
between the Pater and DNA•VIEW results were observed.
remark: In DNA•VIEW there is no automatic calculation using race
mixtures which happens to be less convenient.
Conclusion
No differences between the DNA•VIEW and Pater were found, therefore
the feature Importing GeneScan files can be implemented in
paternity casework.
1-2 Validation of the option DNA•VIEW
Immigration
Introduction
From DNA•VIEW version 21 Immigration is available. Immigration
performs automatically for each locus the calculations in a kinship
situation. This option is validated in DNA•VIEW version 21.15.
Protocol
Twenty known trios from routine casework will be tested. Ten
exclusions and ten proven cases. Five more complex kinship cases
will be analyzed concerning the calculated PI value, the choice of
the paternal fragment and the used formulas.
Criteria
The results of the paternity index calculation using the feature
Immigration and with the standard casework, kinship may only differ
for some slight round off causes.
Results
Testing the twenty trios no differences between the results were
observed. Also in the more complex kinship cases there was no matter
of dispute.
Conclusion
No differences or problems were found. Therefore the feature
Immigration can be used in routine kinship diagnostics.
Introduction
A new hardware device as a new digitizer tablet has to be validated
before it can be implemented in routine paternity testing.
Protocol
The DNA•VIEW settings for this tablet will be performed according to
the manual, after which the communication must be checked. Ten known
X-ray films from routine RFLP testing will be imported in DNA•VIEW
using the A30BL digitizer tablet. Two different readers perform these
reads. The results will be compared with the results form earlier
readings of the same X-ray films.
Criteria
Between the readings of the same gel the differences may not be
greater then 0,8% .
No differences between the readers greater then 0.8% may occur.
Results
In the results a distinction is made between the standards and the
data bands. The results of the readings with the A30BL tablet
compared with the known results of the same X-ray films no
differences larger then 0,8% were observed. Between the two readers
no mutual differences larger then 0,8% were seen.
Conclusion
The results of the acceptation test answer the predefined criteria.
Therefore the new digitizer tablet will be implemented in routine
casework.
3-1 Y2K compliance of DNA•VIEW and Pater
Introduction
According to the DNA•VIEW supplier,
from the DNA•VIEW version 22 and Pater version 12 the
DNA•VIEW program is Y2K convenient.
However according to general guidelines from the European Council of
Accreditation the Y2K compliance must be tested.
Protocol
The testing is performed in a stand-alone environment. Using the
DNA•VIEW version 22.08 and the Pater version 12.02 and the
latest data. The continuity of the running DNA•VIEW program must
be tested during the changeover from 31-12-1999 23.59 hr to
01-01-2000 00.01 hr. The test computer must be set in a year 2000
environment. Twenty old (1999) cases will be retrieved and
calculated. The results will be compared with the old calculations
(1999). To update databases, frequencies have to be counted up to
9999-*****. In the feature quality controls membranes named with the
four-digit year code must be recognized. The feature reread (rework
of old material) will be tested by reread four old (1999) reads and
compared with the old reads.
Criteria
During the conversion to the year 2000 and beyond, problems running
the DNA•VIEW program or discrepancies with earlier results are
not allowed.
Results
Running DNA•VIEW no problems occurred during the conversion to
the year 2000. There were no differences between the results from
twenty old (1999) cases in a 2000 environment and a 1999 environment.
Testing the populations, the database feature caused an error
report. The error was not due to the 2000 environment.
It seems according to the supplier to be a known problem in the
update DNA•VIEW version 22.09. the problem is fixed. The
populations database feature was retested using the DNA•VIEW
version 22.09. The frequencies can be updated to 9999-*****.
In the feature quality controls the membranes named with the
four-digit year codes can be included.
Four membranes from 1999 were reread in the year 2000 environment.
Comparing the results, no differences were seen.
To avoid creating two different versions from one number e.g.
98-12345 and 1998-12345 a dialogue box appears. This feature was
tested twenty times and every time the warning appeared.
Conclusion
According to the results and the Y2K compliance of DNA•VIEW and
Pater declaration of the supplier, the program seems to be millennium
convenient for DNA•VIEW version 22.09 and Pater version 12.02.
