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January 12, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 5 Part A §1(e): Mandatory Anti-HBc Testing for Blood Donors
Slovakia Decree No. 158/2015 Annex 5 Part A §1(e): Mandatory Anti-HBc Testing for Blood Donors
1. Legal Provision and Context
Point (e) of paragraph 1 in Part A of Annex 5 (Príloha č. 5 – časť A, bod 1, písmeno e) to Decree No. 158/2015 Z.z. mandates anti-HBc testing for every blood donor as one of the compulsory serological examinations for markers of transfusion-transmissible infections. This requirement implements EU Directive 2002/98/EC and related technical standards into Slovak law to protect blood product recipients. Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1(e) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
2. Scope of Application
The anti-HBc test is required for:
- All first-time and repeat whole blood donors
- Donors of blood components (plasma, platelets, etc.)
- Autologous donors (where applicable for safety screening)
- Donors in apheresis procedures
Testing must be performed on each donation using validated serological assays. Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1 introductory scope (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
3. Test Interpretation and Follow-up
- Negative anti-HBc: Donation accepted (subject to other mandatory tests).
- Positive anti-HBc: Donation deferred; donor excluded from donation unless further testing (e.g., anti-HBs, HBV-DNA) confirms resolved infection with protective immunity (anti-HBs ≥100 IU/L).
- Isolated anti-HBc positive results require HBV-DNA NAT to exclude occult HBV infection.
Positive results trigger look-back procedures for prior donations. Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1(e) & related follow-up provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
4. Assay and Performance Requirements
- Must use CE-marked serological assays validated for blood screening.
- Sensitivity and specificity requirements align with EU guidelines (≥99.5% for anti-HBc).
- Laboratories must participate in external quality assessment schemes.
Source: Decree No. 158/2015 Z.z. Annex 5 Part A general testing standards (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
5. Documentation and Record-Keeping
Blood establishments must:
- Record test results in the donor’s permanent file
- Maintain traceability from donor to final blood component
- Report positive/confirmed results to the national haemovigilance system
- Retain records for at least 30 years
Source: Decree No. 158/2015 Z.z. Annex 5 Part A record-keeping obligations (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
6. RA and Quality Manager Implications
- Ensure all screening assays are validated and listed in the quality manual
- Implement algorithms for anti-HBc positive follow-up (anti-HBs/HBV-DNA)
- Train staff on deferral criteria and look-back procedures
- Monitor assay performance through internal and external QC
- Prepare for potential updates aligning with EDQM Guide to the Preparation, Use and Quality Assurance of Blood Components
Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1(e) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
7. Alignment with EU Standards
This mandatory anti-HBc testing aligns with:
- EU Directive 2002/98/EC Article 29
- Commission Directive 2004/33/EC Annex III
- EDQM Guide (current edition) recommendations for HBV marker screening
Slovakia applies stricter national rules than minimum EU requirements in some aspects. Source: Decree No. 158/2015 Z.z. Annex 5 Part A (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
8. Practical Checklist for Blood Establishment RA
- Verify anti-HBc assay is CE-marked and validated for screening
- Implement donor questionnaire + anti-HBc + HBV-DNA NAT for positive cases
- Establish deferral/exclusion criteria for isolated anti-HBc positives
- Maintain look-back procedure for prior donations if occult HBV confirmed
- Document all results and decisions in donor file
- Participate in national haemovigilance reporting
Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1(e) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
9. Risks of Non-Compliance
Failure to perform mandatory anti-HBc testing may result in:
- Administrative fines by the Public Health Authority
- Suspension of blood establishment licence
- Product recall and look-back obligations
- Potential liability in case of HBV transmission
Source: Decree No. 158/2015 Z.z. enforcement provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
10. Comparison with Other EU Countries
While anti-HBc screening is mandatory across the EU for blood donations, Slovakia’s explicit inclusion in Annex 5 Part A §1(e) reflects consistent national enforcement. Some Member States apply additional confirmatory testing algorithms or anti-HBs cut-offs for re-entry of donors. Source: Decree No. 158/2015 Z.z. Annex 5 Part A §1(e) (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_5_k_vyhlaske_c_158_2015_z_z.op-skupinaElementov_skusky_vykonavane_pri_vysetreni_darcu_krvi_a_zlozky_z_krvi.op-cast_a.op-odsek_1.op-pismeno_e)
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