In the 2. edition of Clinical and Laboratory Medicine Vol. 49 a group of Doctors from Liegé made a comparison of the two systems.
First they praise the ARCHITECT system….
Then:
“Triage NGAL could be an alternative as the Triage meters can be used in a ward. Unfortunately, the analytical performance of this machine did not fulfil our expectations. Indeed, the method showed important analytical limitations, the primary one being the high variation around the proposed cut-off for the reference value (below 130 mg/L).
Analytical validation of NGAL 341 urement using the cut-off value is thus questionable with the Triage NGAL which shows a high analytical variability around this cut-off value.
Moreover, it must be remembered that this high variation was observed when the analyses were performed under optimal conditions, with a well-trained and experienced technician. In the hands of many different inexperienced nurses in a crowded ward, this variability could be worse.”
This is a fatal blow to Alere’s Triage sytem. More or less.
It should be noted that in the test, they did not take the by Bioporto “protected NGAL Cut-off area” into consideration, so eventhough the ARCHITECHT might be much better than the Triage, we still think its more or less useless under the given circumstances.
However, plasma NGAL was the strongest predictor of AKI progression, with patients in the highest quintile (>322 ng/mL) being 7.7 times more likely to progress than those in the lowest two quintiles (60-164.5 ng/mL).
The article.
no small wonder that the proposed cut-off at 130 ng/ml proved futile. You will have a large number of false positive up until approx. 150
So Alere is risking their credibility in order to defend af undefendable cutoff-value…
It would have been som much easier (and cheaper in the long run) if they had stopped flogging the dead horse (CCH' revorked patent)