Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids.
Needle free jet injection guns have been used extensively in both veterinary and human health to deliver both vaccine and drugs, but in recent years, concerns have mounted for their potential to transmit blood borne disease agents among consecutive vaccinates. A Ped-O-Jet type jet injection device was used to deliver serial subcutaneous injections of 0.5 mL saline (as a surrogate for vaccine) into calves and pigs, with intervening ejectates collected in vials to represent what the next vaccinate would have received. An enzyme linked immunosorbant assay was developed to detect species specific albumin as a marker for blood, using calibration standards from known dilutions of bovine or porcine blood. Assay sensitivity of 20 pL/mL corresponded to the estimated minimal chimpanzee infectious dose of 10 pL for hepatitis B virus. The methodology and available results for evaluating the safety of jet injector devices are reported.
Sweat
J M
JM
Department of Pathobiology, College of Veterinary Medicine, University of Florida, 2015 S.W. 16th Avenue, Gainsville, FL 52608, USA. sweatm@mail.vetmed.ufl.edu
Abdy
M
M
Weniger
B G
BG
Harrington
R
R
Coyle
B
B
Abuknesha
R A
RA
Gibbs
E P
EP
D000818:Animals; D001769:Blood; D001826:Body Fluids; D002138:Calibration; D002417:Cattle; D004340:Drug Contamination; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007277:Injections, Jet; D008954:Models, Biological; D012449:Safety; D012680:Sensitivity and Specificity; D012709:Serum Albumin / Q000032:analysis*; D012710:Serum Albumin, Bovine / Q000032:analysis; D012867:Skin; D013552:Swine; D014612:Vaccines / Q000008:administration & dosage
D012709:Serum Albumin; D014612:Vaccines; D012710:Serum Albumin, Bovine