Human Primary Cells – Pathogen Testing Information

Human Pathogen Testing Standards for ReachBio Research Labs' Primary Human Cell Products

All donors of the source materials used in ReachBio Research Labs’ Human Primary Cell Products, or the source material itself, has been tested and found negative for the common human blood-borne pathogens described below. Testing is done according to industry standards by CLIA-certified and FDA-registered laboratories. Although the human materials used to produce our products have been found to be non-reactive for the presence of the agents specified, all human primary cell products should be treated as potential biohazards as there is no absolute guarantee that the products are free of all pathogens, whether tested for or not.

All ReachBio Research Labs’ Primary Cell Products should be handled at Biological Safety Level 2.

ReachBio Research Labs’ Primary Human Cell Products are intended for In Vitro Research Use only.  Under no circumstances should any of ReachBio Research Labs’ products be injected into humans for any reason whatsoever.

Human Bone Marrow
All bone marrow used in ReachBio Research Labs’ Primary Cell Products is from donors that have bested non-reactive for the presence of:
  • Hepatitis B Virus (HBV)
  • Hepatitis C Virus (HCV)
  • HIV-1

Some bone marrow donors have also been tested for the presence of HIV-2 and some have been tested for syphilis via the NPR test.

Only marrow from non-reactive donors is accepted for use.

Human Blood (Adult)
All donors of peripheral blood/leukapheresis units used in the production of ReachBio Research Labs’ Primary Human Cell Products derived from this source have been tested and found to be non-reactive at the time of each collection for the presence of:
  • HBV
  • HCV
  • HIV-1

Some donors have also been tested for the presence of HIV-2, HTLV-1, syphilis and West Nile Virus.

Only blood from non-reactive donors is accepted for use.

Human Cord Blood
Since the volume of blood in a human umbilical cord is very low, the cord blood used to produce our cryopreserved human cord blood products is not tested itself. However, every maternal donor of cord blood used to produce our products has been found non-reactive for the presence of the following pathogens during pre-natal testing:
  • HBV
  • HIV-1

 

Pathogen Testing Statement last updated: July 10th, 2012