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The limitations of this assay are largely related to the difficulty in interpreting the literature due to lack of standardisation of assay reagents, procedures and scoring.
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Preliminary results presented here indicate a high level of variability in intra- and inter-assay detection of these targets, highlighting the need for standardisation of assays within molecular diagnostics.
Furthermore, we conclude that, as for many other aab, the standardisation of assays requires further effort and attention.
Several commentaries have noted that measurements of IGFBP-3 are still hampered by technical problems, particularly in relation to standardisation of assays.
An index array was stained aside each cohort array to enable standardisation of the assay, along with negative (no primary) and positive controls.
In view of an assay for routine use, addition of 5 μL of PCR product to the hybridisation reaction is preferred over addition of all PCR product, since standardisation of the assay is more straightforward with well-defined volumes.
Background: Several studies on standardisation of NAT assays for diagnosis of hepatitis C virus (HCV) infection have been carried out in European countries.
This illustrates the lack of standardisation of the assays used.
The root of the problem was most likely the challenge of standardisation of the EGFR assay.
However, lack of assay standardisation mandates the need for method-specific decision thresholds and clinical validation in the local population.
The lack of assay standardisation makes it difficult to compare the prevalence of persistent C-peptide production when assessed by different assays [ 16, 17]; our comparison of the methods showed that the Roche assay detects low-level C-peptide in more patients than the Mercodia assay.
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