What You Need To Know
Key messages:
- Several reportable vector-borne infections commonly identified in New Jersey residents are known to be transmitted through infected blood products, including West Nile virus (WNV), Zika virus (ZIKV), babesiosis, malaria, ehrlichiosis and anaplasmosis.
- FDA-approved blood donor screening methods for vector-borne diseases are currently available for: WNV, Babesia, ZIKV, Trypanosoma cruzi, and malaria, although currently, collections in New Jersey are screened routinely for WNV, Babesia and T. cruzi (upon initial donation) only.
- Blood collection agencies should notify the New Jersey Department of Health Communicable Disease Service (CDS) of positive donor screening results.
- If CDS identifies a person with a vector-borne disease whose infection may be transfusion associated or who donated blood in a designated timeframe prior to or after illness onset, CDS will notify the facility where the transfusion took place or where blood was donated so that facilities can initiate internal investigation procedures and adverse event reporting to the blood supplier. CDS will provide a list of the outcomes to be reported during the adverse event investigation.
Action Items:
- If a blood collection agency identifies a presumptively viremic blood donor or presumptively infected blood donor through the screening methods listed below, they should report the results to CDS in one of the following ways:
- automated electronic laboratory reporting (ELR) that uses HL7 messaging1(preferred);
- manual electronic reporting via CDRSS;2
- sending an encrypted e-mail to: CDSVectorTeam@doh.nj.gov; OR
- faxing to NJDOH at: 609-826-4874.
- If needed, request new-user access to CDRSS by going to https://cdrss.nj.gov/, clicking on the Training tab and registering for CDRSS General User Training. In the comments field, specify the type(s) of tests your site will be using. After completing the on-demand training, send a complete User Agreement and Post Test to cdrstrain@doh.nj.gov. After obtaining web entry access, laboratories can request to sign up for automated ELR. Review the ELR Main page and submit the online ELR Enrollment Form.
- If notified that a patient diagnosed with a vector-borne disease donated blood in the following time periods prior to illness onset date or testing, notify CDS:
- Babesia – 12 months, WNV – 30 days, Malaria – 12 months, Zika – 4 months
- If notified by CDS of a suspected vector-borne transfusion-associated infection or recent blood donation in an individual with a vector-borne disease, initiate internal investigation procedures as well as adverse event reporting to the blood supplier.
Screening test reporting:
West Nile Virus:
- One reactive NAAT with a signal-to-cutoff (S/CO) ratio of >17; OR
- Repeatedly reactive NAATs (post reactive NAAT with S/CO ratio of < 17)
Babesiosis
Tests reactive using an FDA-approved/licensed NAAT as described in the May 2019 FDA Guidance for Industry: Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.
Licensed tests/assays:
- Grifols Procleix Babesia Assay for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens for use in screening donors of whole blood and blood components
- Roche cobas Babesia test for the detection of DNA and RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum)
Zika virus
ID NAAT tested initially reactive or ID NAAT reactive post resolution testing of MP NAAT initially reactive; AND one or more of the following:
- Detection of ZIKV RNA in any specimen, including a reactive result by the same or alternate NAAT assay on the same or a follow-up sample; OR
- Positive ZIKV IgM antibody test in serum or CSF with positive ZIKV neutralizing antibody titers in the same or a follow-up sample; OR
- Detection of ZIKV or viral antigen in any specimen
Malaria
FDA-approved test:
- The cobas® malaria test for use on the cobas® 6800/8800 Systems for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA.
Contact Information:
- NJDOH VBD Program E-mail: CDSVectorTeam@doh.nj.gov; Phone: (609) 826-5964; Fax: 609-826-4874
1 NJ Department of Health Communicable Disease Reporting and Surveillance System. How can I develop Electronic Laboratory Reporting (ELR) transmission capability for my facility? nj.gov/health/cd/reporting/cdrss/
2 NJ Department of Health Communicable Disease Reporting and Surveillance System. https://cdrs.doh.state.nj.us/cdrss/login/loginPage