Variances Granted to AABB International Accredited Cord Blood (CB) Facilities

The table below provides details on the variances granted to facilities who have received international accreditation from AABB. The table does not include every AABB-accredited cord blood facility; to view a list of all AABB-accredited cord blood facilities, click here.

Facility	Variance Granted
Cryo-Save Arabia	Test kits for infectious disease testing are CE marked rather than FDA-licensed, approved, or cleared. The laboratory responsible for performing infectious disease testing is accredited by CAP. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
Bionet Corporation	Test kits used for anti-HCV and HBsAg testing are FDA-licensed, approved, or cleared. All others are CE-marked with the exception of HIV RNA, which is performed using an in-house PCR method. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas. The facility stores products in vials rather than bags, using a system that ensures integral linkage between product and sample. The facility is in the process of implementing NAT testing for HIV and HCV.
Healthbanks Cord Blood Center	Test kits used for infectious disease testing are not FDA-licensed, approved, or cleared. All test kits are CE-marked. The facility obtained this variance request for the 3^rd edition. The facility is in the process of implementing NAT testing for HIV and HCV. Renewal request for the 4^th edition is pending.
Discovery Cord Blood Bank/Taiwan Advance Bio-Pharm, Inc.	The facility is in the process of implementing NAT testing for HIV and HCV. Additional information and a renewal request for the 4th edition is pending.
Cordlife PTE, Ltd	Infectious disease testing is not performed in a CMS-approved laboratory. The laboratory is accredited by the Singapore Accreditation Council. Test kits are CE-marked.
National University Hospital	Tests for anti-HTLV-I/II is not performed. With the exception of the test kit used for syphilis, all kits are FDA-licensed, approved, or cleared. Donors will be queried for travel to WNV-endemic areas.
Crioestaminal	Test kits used for infectious disease testing are CE-marked. The laboratory used for infectious disease testing is not CMS-approved. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
The Polish Stem Cells Bank, S.A.	Testing for HTLV-I/II is not required in Poland.
Itabashi Medical Laboratory, Inc.	The laboratory responsible for performing infectious disease testing is not CMS-approved. Test kits used for infectious disease testing are CE-marked rather than FDA-licensed, approved, or cleared.
LifeCell International Private Ltd.	Testing for HTLV-I/II is not required in India. All test kits used for other infectious disease testing are FDA-licensed, approved, or cleared. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
Cell Therapy Technologies Centre, Ltd./Cryolife	Test kits for HIV and HCV RNA are FDA-licensed, approved, or cleared. The other test kits are CE-marked.
HealthBaby Biotech (HK) Co, Ltd	Test kits used for anti-HTLV-I/II and syphilis are FDA-licensed, approved, or cleared; all other test kits are CE-marked. RNA testing for HIV and HCV are performed by a laboratory accredited under the Hong Kong Laboratory Accreditation Scheme (HOKLAS.) WNV testing is not performed, but donors will be queried for travel to WNV-endemic areas.
Medstem Services	Test kits used for infectious disease testing are CE-marked. The facility is expected to submit a timeline for implementation of NAT testing for HIV RNA. WNV testing is not performed, but donors will be queried for travel to WNV-endemic areas.
HealthCord Cryogenics Corporation	The facility uses CE marked tests for performing infectious disease testing. WNV testing is not performed, but donors will be queried for travel to WNV-endemic areas.
Insception Biosciences	All infectious disease test kits are approved by HealthCanada. Of the test kits in use, only those for HTLV-I/II and the serologic test for syphilis are not also approved or cleared by FDA. The laboratory responsible for infectious disease testing is accredited by the appropriate provincial authority but is not CLIA-certified. Implementation of NAT testing for HIV and HCV is in progress. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
CordVida	Test kits are CE-marked rather than FDA-licensed, approved, or cleared. The laboratory performing infectious disease testing is accredited by AABB. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
Cryoviva Thailand Ltd.	Testing for anti-HBc and HTLV-I/II is not required in Thailand. With the exception of syphilis testing, kits are CE-marked rather than FDA-licensed, approved, or cleared. The laboratory responsible for performing infectious disease testing is ISO 15189-certified, but is not CLIA-certified. WNV testing is not required, but donors will be queried for travel to WNV-endemic areas.
Cryopraxis Criobiologia LTDA	The facility is expected to submit a timeline for the implementation of HIV and HCV NAT. The facility uses a CAP-accredited laboratory for infectious disease testing.
Hospital Nacional de Pediatría SAMIC	Test kits are CE-marked rather than FDA-licensed, approved, or cleared, with the exception of HIV and HCV RNA kits, which are FDA-cleared.
Hospital de Pediatria Garrahan	The laboratory responsible for performing infectious disease testing is not CMS-approved. Test kits are CE marked and approved by the local health authority. The facility is expected to submit a timeline for the implementation HIV and HCV NAT.
KRIO Sejt-es Szovetbank Zrt.	Testing for HTLV-I/II is not required in Hungary. The facility uses an external laboratory to perform all infectious diseases testing, including NAT for HIV and HCV.
Biohellenika S.A.	The facility uses an ISO 15189-certified testing laboratory for all donor infectious disease testing. The laboratory uses CE marked materials (including reagent test kits) in place of FDA-approved materials. Tests are approved by the Greek Ministry of Health. Testing for HTLV-I/II is not required in Greece. The laboratory participates in an external proficiency testing program that is not CMS-approved. The facility stores products in vials rather than bags, using a system that ensures integral linkage between product and sample.
Netcells Cryogenics	The facility uses an ISO 15189-certified testing laboratory for all donor infectious disease testing.
National University Hospital	Testing for HTLV-I/II and anti-HBc is not required in performed in Singapore.
Guangzhou Cord Blood Bank	The laboratory responsible for performing infectious disease testing is not CMS-approved. The laboratory uses donor screening assays that are approved by the Chinese Ministry of Health.
C.B.B. Lifeline Biotech Ltd.	WNV and HTLV I/II testing is not required in Cyprus, but donors will be queried for travel to WNV-endemic areas.
Cryobanks International India	The laboratory uses a facility approved by the India Ministry of Health for donor testing. The facility uses materials approved by the Drugs Controller General of India instead of FDA-approved materials. The laboratory uses CE-marked materials (including reagent test kits) in place of FDA-approved materials. Tests are approved by the Government of India.
Jiangsu Blood Center	The laboratory uses a facility approved by the Chinese Ministry of Health for donor testing. The laboratory uses materials and test kits approved by the Chinese Ministry of Health. Testing for HTLV I/II is not performed. WNV testing is not performed but donors are screened for travel to WNV-endemic areas.
Beijing Cord Blood Bank	The laboratory uses a facility approved by the Chinese Ministry of Health.
HealthBanks Biotech Co. Ltd.	The laboratory uses a testing laboratory approved by the Taiwan Ministry of Health.
Cordlife (Hong Kong) Ltd.	The facility uses an ISO 15189 HOKLAS-cleared testing laboratory for all donor and recipient sample testing. The facility uses CE-marked tests for performing infectious disease testing.
The Chaim Sheba Medical Center	The facility is using a CE-marked West Nile Virus testing kit.
Singapore General Hospital	Some test kits and materials are not FDA-licensed, approved, or cleared.