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Fasciola hepatica (Trematoda)
ELISA kit for the diagnosis of human fascioliasis

Lot 1615D

 

Results of quality control

Kit: Bordier Affinity Products SA, Fasciola hepatica ELISA, Article 9650.
Expiry date: 06.02.2018, Control date: 02.06.2017,  Control #  3

No serum blank (average) : 0.139

Sample

Absorbances of individual wells after blank reduction

Average

% pos.

No serum blank
(TBS-Tween)
-0.004 0.001 0.004 -0.001 0.000 0
Negative control serum
(N° 965
0-06)
0.172 0.174 0.170 0.160 0.169 8
Weak positive serum
(N° 965
0-07)
0.381 0.323 0.314 0.317 0.333 15
Positive control serum
(N° 9650
-08)
2.133 2.319 2.217 2.299 2.242 100

Validation criteria:

  Criterion Measure Valid
Absorbance of positive serum 9650-08 > 1.200 2.242 Yes
Absorbance of negative serum 9650-06, as % of positive serum < 8 % 8 % Yes
Absorbance of no serum blank < 0.350 0.139 Yes

Comments:

The negative serum 9650-06 just exceeds its specification of <8%. Further experiments have been made to insure that it was a ponctual non coformity. The threshold and so the diagnostic value of the product are not affected, nethertheless the product is under watching for future quality controls.
Good for use.

Bordier Affinity Products SA, Chatanerie 2, Bātiment Biokema, CH-1023 Crissier, Switzerland
Phone: + 41 21 633 31 67.  Fax: + 41 21 633 31 78. Email: cb(at)bordier.ch