D. DO NOT COMPLY WITH PERFORMANCE STANDARDS; ARE HELD AND WILL REMAIN UNDER BOND; AND WILL NOT BE. INTRODUCED INTO COMMERCE UNTIL NOTIFICATION IS RECEIVED FROM FDA THAT PRODUCTS HAVE BEEN BROUGHT. INTO COMPLIANCE IN ACCORDANCE WITH AN FDA APPROVED PETITION.
HHMI researchers identify gene mutations that cause a potentially fatal clotting disorder. Researchers have determined the cause of a potentially deadly inherited blood-clotting disorder that can lead to kidney failure or stroke. The researchers found that the disorder, thrombotic thrombocytopenic purpura (TTP), is caused by mutations in a gene that render the ADAMTS13 enzyme ineffective.
Reptilase time measures the time to clot formation after the addition of reptilase, a thrombin-like snake enzyme, to citrated blood. Unlike the TT, it is not affected by heparin. It can be useful to determine whether heparin is the cause of the prolonged TT. The 1:1 mixing study is done when the PT or aPTT is prolonged. The patient's plasma is mixed with normal plasma, and the test is repeated. If the mixing of normal plasma corrects the abnormal result (PT or aPTT), a factor deficiency is suggested; otherwise, an inhibitor is suspected.