Never backward in coming forward Oxford Immunotec Inc welcomed the new guidelines
saying;
Since obtaining premarket approval from the Food and Drug Administration (FDA) in July 2008, the T-SPOT.TB test has become widely utilized in hospitals, medical practices and public health facilities throughout the United States. The T-SPOT.TB test is backed by the clinical evidence of over 200 peer-reviewed publications, and is the only IGRA with both sensitivity and specificity exceeding 95% in FDA pivotal trials
The updated CDC guidelines do make mention of T-Spot;
The T-Spot interpretation criteria approved by FDA for use in the United States differ from those used in other countries. Also, the majority of published studies evaluating T-Spot have used criteria that differ from those approved by FDA.
What more can I say?
