A multi-center study in the U.S. and China involving a total of 393 healthy
subjects and 203 lung cancer patients was conducted to investigate the uti
lity of DR-70(TM) immunoassay to detect lung cancer. Interference to DR-70(
TM) test due to different disease states and blood collection procedures we
re also investigated. Benign and non-cancer diseases that can give rise to
elevated DR-70(TM) levels included pneumonia, lung infection, burns, trauma
due to surgery, arthritis, renal failure, sepsis etc. The study also showe
d that most consistent DR-70(TM) test results were obtained when blood was
collected in vacutainers containing SST gel and clot activator. It is impor
tant that the DR-70(TM) test not be performed on samples of patients suffer
ing from the aforementioned diseases. As these noncancer disease states and
improper blood collection procedures may lead to false positive results.