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VIDAS LPT - Summary 2012
EUROFINS IPL Nord SAS
–
1 rue du Professeur Calmette
–
59046 LILLE cedex
p 12/14
The degrees of accordance for each of the methods, at each of the levels are given below.
Level
Reference method
Alternative method
L0
DA % =
100,0
DA % =
100,0
L1
DA % =
82,1
DA % =
84,8
L2
DA % =
94,0
DA % =
97,0
3.5.3 Concordance (COR)
The concordance is the percentage of likelihood of obtaining the same result for two identical samples analyzed in
two different laboratories.
It thus consists of calculating the percentage of all the pairs giving the same results on all the possible pairs of
results.
The concordance percentages for each of the methods, at each of the levels are given below:
Level
Reference method
Alternative method
L0
Concordance % =
100,00
Concordance % =
100,00
L1
Concordance % =
48,63
Concordance % =
50,89
L2
Concordance % =
92,75
Concordance % =
96,46
3.5.4 Odds Ratio (COR)
Calculated using the following formula:
COR = accordance x (100
–
concordance)
concordance x (100
–
accordance)
The odds ratios for each of the methods, at each of the levels are given below:
Level
Reference method
Alternative method
L0
COR =
1,00
COR =
1,00
L1
COR =
1,69
COR =
1,67
L2
COR =
1,01
COR =
1,00
An odds ratio value of 1.00 means that the degree of agreement and the consistency are equal.
The higher is the Odds Ratio, the more predominant is the inter-laboratory variation.
4 Practicability
The practicability is studied based on the 13 criteria defined by AFNOR Certification by comparing the reference
method to the alternative method
.
The defined criteria are summarized below:
1.Method component - packaging mode
(see package insert)
2.Reagent volume (see package insert
and bottle packaging)
The kits are packaged in 60-test kits containing:
- the LPT strips, consisting of 10 wells covered with aluminum foil,
- the LPT SPRs, in aluminum pouches containing 30 units, with a desiccant,
- the bottle of LPT standard S1 (6 mL)
- the bottles of positive and negative LPT controls C1 and C2 (6 mL)
3.
Component storage conditions and
Shelf-life of unopened products (see
package insert)
The test storage temperature is 2 - 8 °C.
The shelf-life of tests is mentioned on the kits.
4.
Conditions for use after first use (see
package insert)
Each reagent should be stored between +2°C and +8°C.