MD975Z - Method for donor blood testing for hepatitis B virus markers - Google Patents
Method for donor blood testing for hepatitis B virus markers Download PDFInfo
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- MD975Z MD975Z MDS20150008A MDS20150008A MD975Z MD 975 Z MD975 Z MD 975Z MD S20150008 A MDS20150008 A MD S20150008A MD S20150008 A MDS20150008 A MD S20150008A MD 975 Z MD975 Z MD 975Z
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- 239000008280 blood Substances 0.000 title claims abstract description 56
- 210000004369 blood Anatomy 0.000 title claims abstract description 56
- 238000000034 method Methods 0.000 title claims abstract description 9
- 241000700721 Hepatitis B virus Species 0.000 title abstract description 6
- 238000012360 testing method Methods 0.000 title description 9
- 239000000427 antigen Substances 0.000 claims abstract description 5
- 102000036639 antigens Human genes 0.000 claims abstract description 5
- 108091007433 antigens Proteins 0.000 claims abstract description 5
- 208000002672 hepatitis B Diseases 0.000 claims description 16
- 208000015181 infectious disease Diseases 0.000 abstract description 7
- 239000003814 drug Substances 0.000 abstract description 2
- 230000005180 public health Effects 0.000 abstract description 2
- 239000003550 marker Substances 0.000 description 5
- 230000005540 biological transmission Effects 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- 230000001154 acute effect Effects 0.000 description 2
- 230000002458 infectious effect Effects 0.000 description 2
- 239000010836 blood and blood product Substances 0.000 description 1
- 229940125691 blood product Drugs 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000004719 natural immunity Effects 0.000 description 1
- 230000009800 post vaccination immunity Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000007420 reactivation Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000000405 serological effect Effects 0.000 description 1
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Abstract
Description
Invenţia se referă la medicină, în special la domeniul ocrotirii sănătăţii publice şi poate fi utilizată pentru prevenirea infectării cu virusul hepatitei virale B prin transfuzie de sânge. The invention relates to medicine, in particular to the field of public health protection and can be used to prevent infection with the hepatitis B virus through blood transfusion.
Este cunoscută metoda de testare a sângelui donat la markerii hepatitei virale B prin reacţia imunoenzimatică, care include testarea la AgHBs, anticorpii AntiHBcor sumari şi anticorpii Anti HBs (Screening Donated Blood for Transfusion Infections, WHO Recommendations 2009). Detecţia antigenului AgHBs confirmă prezenţa infecţiei cu virusul hepatitei B. AntiHBcor sumar (include anticorpii AntiHBcor din clasa IgM şi din clasa IgG) este un marker serologic al hepatitei B prezent în toate fazele bolii şi recuperării (Vrânceanu-Beneş Angela, Spînu Constantin, Iarovoi Petru, Popa Mariana, Metodă de diagnostic al hepatitei virale B la copii de până la un an, Brevet MD 34 din 2008.05.20). Anticorpii AntiHBs indică prezenţa imunităţii naturale sau postvaccinale la această infecţie. Conform algoritmului cunoscut, sângele donat se testează în prima etapă la antigenul AgHBs, şi dacă rezultatul este pozitiv, sângele este suspendat, iar dacă rezultatul este negativ, atunci sângele se testează la anticorpii AntiHBcor sumari şi AntiHBs în scopul depistării hepatitei virale B oculte (hepatita virală B AgHBs negativă), care se întâlneşte cel mult la 15% de cazuri la persoanele cu AntiHBcor sumari prezenţi [1]. În cazul rezultatului negativ la anticorpii AntiHBcor sumari sângele donat este validat pentru utilizare, iar dacă rezultatul este pozitiv, sângele se testează la anticorpii AntiHBs. În cazul concentraţiei AntiHBs mai mari de 100 mUI/ml, sângele este validat pentru utilizare, iar dacă concentraţia AntiHBs este mai mică de 100 mUI/ml, atunci proba de sânge este suspendată. The method of testing donated blood for markers of viral hepatitis B by immunoenzymatic reaction is known, which includes testing for AgHBs, AntiHBcor antibodies and Anti HBs antibodies (Screening Donated Blood for Transfusion Infections, WHO Recommendations 2009). Detection of AgHBs antigen confirms the presence of hepatitis B virus infection. AntiHBcor antibodies (including AntiHBcor antibodies of the IgM class and IgG class) is a serological marker of hepatitis B present in all phases of the disease and recovery (Vrânceanu-Beneş Angela, Spînu Constantin, Iarovoi Petru, Popa Mariana, Method for diagnosing viral hepatitis B in children up to one year of age, Patent MD 34 of 2008.05.20). AntiHBs antibodies indicate the presence of natural or post-vaccination immunity to this infection. According to the known algorithm, donated blood is tested in the first stage for the AgHBs antigen, and if the result is positive, the blood is suspended, and if the result is negative, then the blood is tested for AntiHBcor summary and AntiHBs antibodies in order to detect occult viral hepatitis B (HBs Ag-negative viral hepatitis B), which occurs in no more than 15% of cases in people with present AntiHBcor summary [1]. In case of negative result for AntiHBcor summary antibodies, the donated blood is validated for use, and if the result is positive, the blood is tested for AntiHBs antibodies. In case of AntiHBs concentration higher than 100 mIU/ml, the blood is validated for use, and if the AntiHBs concentration is lower than 100 mIU/ml, then the blood sample is suspended.
Dezavantajele acestei metode constau în aceea că aplicarea algoritmului nominalizat nu permite detectarea tuturor cazurilor de hepatită virală B ocultă, ca urmare există pericolul transmiterii virusului hepatitei B prin transfuzia sângelui. Conform datelor din literatură, în ţările endemice cel puţin 1% de persoane în lipsa AgHBs şi prezenţa AntiHBcor sumar, indiferent de concentraţia AntiHBs, pot avea hepatită virală B ocultă şi potenţial sunt infecţioşi [1]. The disadvantages of this method are that the application of the nominated algorithm does not allow the detection of all cases of occult viral hepatitis B, as a result of which there is a danger of transmission of the hepatitis B virus through blood transfusion. According to the literature, in endemic countries at least 1% of people in the absence of HBsAg and the presence of AntiHBcor summary, regardless of the concentration of AntiHBs, may have occult viral hepatitis B and are potentially infectious [1].
Problema pe care o rezolvă invenţia este sporirea eficacităţii triajului sângelui donat în scopul prevenirii transmiterii hepatitei virale B prin transfuzie de sânge de la persoane cu hepatită virală B ocultă. The problem solved by the invention is to increase the effectiveness of screening donated blood in order to prevent the transmission of viral hepatitis B through blood transfusion from persons with occult viral hepatitis B.
Esenţa invenţiei constă în aceea că în sângele menţionat se determină antigenul HBs, ulterior în cazul unui rezultat pozitiv sângele nu poate fi utilizat pentru transfuzii, iar când rezultatul este negativ sângele se testează la markerii AntiHBcor sumari şi în cazul unui rezultat negativ sângele donatorului poate fi utilizat pentru transfuzii, iar când rezultatul este pozitiv în sânge se determină markerii AntiHBcorIgM şi în cazul unui rezultat pozitiv sângele nu poate fi utilizat pentru transfuzii, iar când rezultatul este negativ în sânge se determină markerii AntiHBs şi în cazul în care concentraţia anticorpilor este mai mică de 100 mUI/ml sângele nu poate fi transfuzat, iar când concentraţia anticorpilor este mai mare de 100 mUI/ml sângele poate fi utilizat pentru transfuzii. The essence of the invention is that the HBs antigen is determined in the mentioned blood, subsequently in case of a positive result the blood cannot be used for transfusions, and when the result is negative the blood is tested for summary AntiHBcor markers and in case of a negative result the donor's blood can be used for transfusions, and when the result is positive in the blood the AntiHBcorIgM markers are determined and in case of a positive result the blood cannot be used for transfusions, and when the result is negative in the blood the AntiHBs markers are determined and in case of a positive result the blood cannot be used for transfusions, and in case of a negative result the blood cannot be transfused, and in case of a negative result the blood can be used for transfusions.
Invenţia se explică cu ajutorul figurii, în care este descrisă metoda de determinare a markerilor hepatitei virale B în sângele donatorului. The invention is explained with the help of the figure, which describes the method of determining markers of viral hepatitis B in the donor's blood.
Rezultatul constă în crearea unei metode noi de testare a sângelui donat la markerii hepatitei virale B, care reduce posibilitatea de transmitere a virusului hepatitei B prin transfuzie de sânge. De asemenea, prin această metodă sunt excluse din transfuzie produsele de sânge ale persoanelor cu hepatită virală B ocultă acută sau în reactivare. The result is a new method of testing donated blood for markers of viral hepatitis B, which reduces the possibility of hepatitis B virus transmission through blood transfusion. This method also excludes from transfusion blood products from people with acute occult or reactivated viral hepatitis B.
Pentru aprobarea metodei propuse de testare a sângelui donat în cadrul Centrului Naţional de Transfuzie a Sângelui pe parcursul anului 2013 conform algoritmului propus au fost testate la markerii AntiHBcor sumar, AntiHBs şi AntiHBcor IgM, 78769 probe negative la testul AgHBs. For the approval of the proposed method of testing donated blood within the National Blood Transfusion Center during 2013, according to the proposed algorithm, 78,769 samples negative for the AgHBs test were tested for the AntiHBcor summary, AntiHBs and AntiHBcor IgM markers.
Rezultatele testării sunt prezentate în tabel. The test results are presented in the table.
Tabel Table
Rezultatele testării sângelui donatorului la markerii hepatitei virale B Results of donor blood testing for markers of viral hepatitis B
Markeri Total investigaţi Rezultat Ponderea, % AntiHBcor sumar 78769 pozitiv negativ pozitiv negativ 23866 54903 30,3 69,7 AntiHBs 24885 >100 mUI/ml <100 mUI/ml >100 mUI/ml <100 mUI/ml 13172 11713 52,9 47,1 AntiHBcor IgM 13371 pozitiv negativ pozitiv negativ 109 13262 0,8 99,2Markers Total investigated Result Weight, % AntiHBcor summary 78769 positive negative positive negative 23866 54903 30.3 69.7 AntiHBs 24885 >100 mIU/ml <100 mIU/ml >100 mIU/ml <100 mIU/ml 13172 11713 52.9 47.1 AntiHBcor IgM 13371 positive negative positive negative 109 13262 0.8 99.2
Rezultatele obţinute demonstrează că 30,3% de probe negative în testul la detectare a AgHBs sunt pozitive la markerul AntiHBcor sumar. Din aceste probe pozitive la AntiHBcor sumar 52,9% au cantitatea de anticorpi către AgHBs mai mare de 100 mUI/ml de sânge şi, conform algoritmului existent recomandat (Screening Donated Blood for Transfusion Infections, WHO Recommendations 2009), sunt validate pentru donare. Restul 47,1% de probe cu cantitatea Anti HBs mai mică de 100 mUI/ml de sânge sunt suspendate de la donare. Rezultatele testării la markerul AntiHBcor IgM a probelor cu cantitatea AntiHBs mai mare de 100 mUI/ml de sânge denotă că 0,8% (numărul absolut - 109) de probe sunt pozitive la acest marker şi donatorii respectivi suferă de HVB ocultă acută sau în reactivare şi potenţial sunt infecţioşi. The results obtained demonstrate that 30.3% of negative samples in the HBsAg detection test are positive for the AntiHBcor summary marker. Of these samples positive for AntiHBcor summary, 52.9% have the amount of antibodies to HBsAg greater than 100 mIU/ml of blood and, according to the existing recommended algorithm (Screening Donated Blood for Transfusion Infections, WHO Recommendations 2009), are validated for donation. The remaining 47.1% of samples with the Anti HBs amount less than 100 mIU/ml of blood are suspended from donation. The results of testing for the AntiHBcor IgM marker of samples with the AntiHBs amount greater than 100 mIU/ml of blood indicate that 0.8% (absolute number - 109) of samples are positive for this marker and the respective donors suffer from acute occult HBV or in reactivation and are potentially infectious.
Astfel aplicarea metodei propuse a permis prevenirea transfuziei sângelui de la 109 donatori infectaţi cu virusul hepatitei B. Thus, the application of the proposed method allowed the prevention of blood transfusion from 109 donors infected with the hepatitis B virus.
De asemenea testarea la markerul AntiHBcor IgM a probelor de la toţi donatorii negativi în testul la AgHBs şi pozitivi la AntiHBcor sumar permite diagnosticarea exactă a hepatitei virale B oculte la aceste persoane. Also, testing for the AntiHBcor IgM marker of samples from all donors negative in the HBsAg test and positive in the AntiHBcor summary allows for the accurate diagnosis of occult viral hepatitis B in these individuals.
Astfel, metoda propusă asigură un nivel mai înalt de securitate transfuzională faţă de cea mai apropiată soluţie. Thus, the proposed method ensures a higher level of transfusion safety compared to the closest solution.
1. Mauss, Berg, Rockstroh, Sarrazin, Wedemeyer. "Hepatology a Clinical Textbook", Edition 2012 1. Mauss, Berg, Rockstroh, Sarrazin, Wedemeyer. "Hepatology a Clinical Textbook", Edition 2012
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| MDS20150008A MD975Z (en) | 2015-01-28 | 2015-01-28 | Method for donor blood testing for hepatitis B virus markers |
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| MDS20150008A MD975Z (en) | 2015-01-28 | 2015-01-28 | Method for donor blood testing for hepatitis B virus markers |
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| MD975Z true MD975Z (en) | 2016-07-31 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110057954A (en) * | 2019-04-30 | 2019-07-26 | 中国医学科学院病原生物学研究所 | Blood plasma metabolic markers are in the application for diagnosing or monitoring HBV |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD1166Z (en) * | 2017-01-19 | 2018-02-28 | Национальный Центр Общественного Здоровья Министерства Здравоохранения Республики Молдова | Method for testing donor blood for viral hepatitis B markers |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD302F1 (en) * | 1995-04-21 | 1995-10-31 | Lidia Gavrilita | Process for storing cereal moth eggs Sitotroga Cerealella O |
| MD1875G2 (en) * | 1999-11-01 | 2002-09-30 | Национальный Научно-Практический Центр Превентивной Медицины Министерства Здравоохранения Республики Молдова | Method of treatment of the acute viral hepatitis B |
| MD34Y (en) * | 2008-05-20 | 2009-06-30 | Centrul National Stiintifico-Practic De Medicina Preventiva Al Ministerului Sanatatii Al Republicii Moldova | Method for diagnosing the viral hepatitis B to babies of up to one year |
| MD5Z (en) * | 2008-07-17 | 2009-09-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for eliminating the dislocation of the intraocular lens |
| MD219Z (en) * | 2010-03-05 | 2011-01-31 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for determining the degree of activity of chronic viral hepatitis C |
| MD223Z (en) * | 2010-03-05 | 2011-02-28 | Национальный Научно-Практический Центр Превентивной Медицины Министерства Здравоохранения Республики Молдова | Method for revaccination of children against viral hepatitis B |
| UA60490U (en) * | 2010-11-04 | 2011-06-25 | Абдурашид Алифендьевич Абдурашидов | Method for expanding of intercalated graphite |
| MD319Z (en) * | 2010-06-30 | 2011-08-31 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for diagnosis of chronic viral hepatitis D and mixed hepatitis B+C |
| RU2531938C1 (en) * | 2013-07-17 | 2014-10-27 | Государственное бюджетное образовательное учреждение высшего профессионального образования "Нижегородская государственная медицинская академия" Министерства Здравоохранения Российской Федерации (ГБОУ ВПО НижГМА Минздрава России) | Method for prediction of chronicity of viral hepatitis b in children with food allergy |
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- 2015-01-28 MD MDS20150008A patent/MD975Z/en not_active IP Right Cessation
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MD302F1 (en) * | 1995-04-21 | 1995-10-31 | Lidia Gavrilita | Process for storing cereal moth eggs Sitotroga Cerealella O |
| MD1875G2 (en) * | 1999-11-01 | 2002-09-30 | Национальный Научно-Практический Центр Превентивной Медицины Министерства Здравоохранения Республики Молдова | Method of treatment of the acute viral hepatitis B |
| MD34Y (en) * | 2008-05-20 | 2009-06-30 | Centrul National Stiintifico-Practic De Medicina Preventiva Al Ministerului Sanatatii Al Republicii Moldova | Method for diagnosing the viral hepatitis B to babies of up to one year |
| MD5Z (en) * | 2008-07-17 | 2009-09-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for eliminating the dislocation of the intraocular lens |
| MD219Z (en) * | 2010-03-05 | 2011-01-31 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for determining the degree of activity of chronic viral hepatitis C |
| MD223Z (en) * | 2010-03-05 | 2011-02-28 | Национальный Научно-Практический Центр Превентивной Медицины Министерства Здравоохранения Республики Молдова | Method for revaccination of children against viral hepatitis B |
| MD319Z (en) * | 2010-06-30 | 2011-08-31 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Method for diagnosis of chronic viral hepatitis D and mixed hepatitis B+C |
| UA60490U (en) * | 2010-11-04 | 2011-06-25 | Абдурашид Алифендьевич Абдурашидов | Method for expanding of intercalated graphite |
| RU2531938C1 (en) * | 2013-07-17 | 2014-10-27 | Государственное бюджетное образовательное учреждение высшего профессионального образования "Нижегородская государственная медицинская академия" Министерства Здравоохранения Российской Федерации (ГБОУ ВПО НижГМА Минздрава России) | Method for prediction of chronicity of viral hepatitis b in children with food allergy |
Non-Patent Citations (1)
| Title |
|---|
| Mauss, Berg, Rockstroh, Sarrazin, Wedemeyer. "Hepatology a Clinical Textbook", Edition 2012 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110057954A (en) * | 2019-04-30 | 2019-07-26 | 中国医学科学院病原生物学研究所 | Blood plasma metabolic markers are in the application for diagnosing or monitoring HBV |
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| Publication number | Publication date |
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| MD975Y (en) | 2015-12-31 |
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