RT-PCR based molecular assays have recently been developed for individual BTV types [60] [63] that are more rapid and more reliable than these conventional serological methods and have become standard diagnostic tests in many BTV reference laboratories.
As with many reference values, laboratory parameters will also vary from laboratory to laboratory resulting in slightly varying ranges for the 'healthy' populations evaluated.
The technical skill required for MAT limits its use in many non-reference laboratories, particularly in low-to-middle income countries [ 5].
Nucleic acid tests such as PCR are done to rule out the presence of infectious agents during the processing of plasma for products like IVIG, and are available in many hospital and commercial reference laboratories.
This outcome may even be considered optimistic with respect to the situation in practice, since the laboratories involved were national reference laboratories, while in many countries the initial screening is delegated to routine field laboratories.
Serum samples were also referred to the reference laboratories.
Though for many years WHO and the Pan American Health Organisation have supported external validation of samples in selected reference laboratories, it is unclear how many local laboratories use that service.
Antigens for production of vaccines or antisera are maintained and distributed by official reference laboratories [ 10] and in many cases, these antigens are produced with AI viruses isolated more than a decade ago (e.g. [ 13, 14]).
Thus, many clinical laboratories refer confirmatory testing to off-site regional or commercial reference laboratories, such that the turnaround time is too slow to aid in real-time patient management [3, 4].
Owing to the poor concordance between HER2 status established in local laboratories in comparison to reference laboratories, we also think that, in many laboratories, CISH may be an excellent method to calibrate IHC procedures or, as a quality control test, to check regularly that the IHC signal is in agreement with gene status.
