In Vivo Virus Assay (Protocol 1514.005002 M.A.. Inc.) : 
This test includes the inoculation of adult mice, suckling mice, guinea pigs and embryonated 
hens eggs via yolk sack and allantoic routes of inoculation. All animals are observed for clinical 
signs of viral infection. Suckling mice are sacrificed on day 14 for the preparation of a tissue 
homogenate which is inoculated into a new group of suckling mice. Specific Pathogen Free 
(SPF) eggs are examined for viability and the blind passage of fluids into new eggs is performed. 
Karyology Assay (Protocol 1516.0 18 M.A.. Inc.): 
This test is designed to confirm the species identity of cultured cells by means of isozyme and 
cytogenetic analysis. 
Tumorigenicity Assay (Protocol 1514.001 M.A.. Inc.) : 
This study utilizes athymic nude mice which are inoculated subcutaneously with cells. Animals 
are observed for clinical signs, palpated bi-weekly, and submitted for histopathology evaluation 
of multiple tissues. Any animal which shows a regressing nodule is sacrificed and submitted for 
histopathological examination. 
EBV Probe Assay (Protocol 1516.104 M.A.. Inc.l : 
The purpose of this study is to detect EBV DNA that may be present in the test article as 
determined by Southern hybridization using a labeled DNA probe. DNA is extracted from the test 
article cell pellet and blotted onto membranes. Blotted membranes are hybridized to a labeled 
EBV probe and detected by autoradiography. DNA from Namalwa cells are included as a positive 
control. 
Cytomegalovirus (Protoc ol 1514.030 M.A.. Inc.l : 
The test and control articles are directly inoculated onto cell cultures (indicator cells) and 
examined for 42 days for the appearance of cytopathic effect. Additionally, cells are fixed and 
examined using immunofluorescent techniques. 
HIV Co-cultivation Assay (Protocol 1516.015001 M.A.. Inc.) : 
This procedure is designed to detect small amounts of retrovirus that may be present in the test 
article. To amplify any virus present, selected Peripheral Blood Lymphocytes (PBL) cells are 
infected, mixed with test article, passaged and analyzed for HIV by observing for cytopathic 
effect (CPE) and production of viral antigens by antigen capture ELISA. 
B ovine Virus Assay (Protocol 1514.032001 M.A.. Inc.) : 
This study is designed to detect bovine viruses such as Bovine Viral Diarrhea Virus (BVD), 
Infectious Bovine Rhinotracheitis Virus (IBR), Parainfluenza 3 (PI 3), Bovine Adenovirus 
(BA), or Bovine Parvovirus (BP) using sensitive indicator cells and immunofluorescence and 
cytopathic effect (CPE) as endpoints. 
Hepatitis B (Protocol 1516.040 M.A.. Inc.) : 
This procedure is designed to detect small amounts of Hepatitis B surface antigen that may be 
present in the test article which would be detected by a third generation ELISA assay. 
Porcine P arvovirus (Protocol 1514.033004 M.A.. Inc.h 
This assay is designed to detect Porcine Parvovirus (PPV) in cell cultures. Test and control 
articles are analyzed by inoculation of indicator cell cultures and examined for at least 14 days 
for the presence of CPE. Cultures are also tested for the presence of specific viral antigens 
using fluorescent antibody techniques. 
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Recombinant DNA Research, Volume 16 
