MD1166Z - Method for testing donor blood for viral hepatitis B markers - Google Patents
Method for testing donor blood for viral hepatitis B markers Download PDFInfo
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- MD1166Z MD1166Z MDS20170004A MDS20170004A MD1166Z MD 1166 Z MD1166 Z MD 1166Z MD S20170004 A MDS20170004 A MD S20170004A MD S20170004 A MDS20170004 A MD S20170004A MD 1166 Z MD1166 Z MD 1166Z
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- 239000008280 blood Substances 0.000 title claims abstract description 56
- 210000004369 blood Anatomy 0.000 title claims abstract description 56
- 238000012360 testing method Methods 0.000 title claims abstract description 14
- 208000002672 hepatitis B Diseases 0.000 title claims abstract description 11
- 238000000034 method Methods 0.000 title description 6
- 241000700721 Hepatitis B virus Species 0.000 claims abstract description 6
- 239000000427 antigen Substances 0.000 claims description 5
- 102000036639 antigens Human genes 0.000 claims description 5
- 108091007433 antigens Proteins 0.000 claims description 5
- 238000010998 test method Methods 0.000 claims description 2
- 208000015181 infectious disease Diseases 0.000 abstract description 8
- 239000003814 drug Substances 0.000 abstract description 2
- 238000004448 titration Methods 0.000 abstract 1
- 208000006454 hepatitis Diseases 0.000 description 10
- 231100000283 hepatitis Toxicity 0.000 description 10
- 239000003550 marker Substances 0.000 description 10
- 108020004414 DNA Proteins 0.000 description 8
- 206010019799 Hepatitis viral Diseases 0.000 description 7
- 201000001862 viral hepatitis Diseases 0.000 description 7
- 230000009385 viral infection Effects 0.000 description 7
- 238000001514 detection method Methods 0.000 description 4
- 230000002458 infectious effect Effects 0.000 description 3
- 108020005202 Viral DNA Proteins 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 230000007717 exclusion Effects 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 101710132601 Capsid protein Proteins 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 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
- 238000013213 extrapolation Methods 0.000 description 1
- 230000004719 natural immunity Effects 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- 230000009800 post vaccination immunity Effects 0.000 description 1
- 230000000405 serological effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
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Abstract
Invenţia se referă la medicină şi poate fi utilizată pentru testarea sângelui donatorului la markerii hepatitei virale B cu scop de prevenire a infectării în cazul transfuziei de sânge.Esenţa invenţiei constă în aceea că în sânge se determină succesiv prezenţa antigenului AgHBs, anticorpilor antiHBcor sumar, antiHBcor IgM şi antiHBs, iar pentru sângele cu titrul la antiHBs mai mare de 100 mUI/ml, suplimentar se efectuează testul la ADN al virusului hepatitei B şi în cazul în care testul este pozitiv, se stabileşte prezenţa markerilor hepatitei virale B în sângele donatorului.The invention relates to medicine and can be used to test donor blood for markers of viral hepatitis B with the purpose of preventing infection in the case of blood transfusion. IgM and antiHBs, and for blood with an antiHBs titration greater than 100 mUI / ml, additionally the hepatitis B virus DNA test is performed and if the test is positive, the presence of viral hepatitis B markers in the donor blood is established.
Description
Invenţia se referă la medicină şi poate fi utilizată întru prevenirea infectării cu virusul hepatitei virale В ca urmare a transfuziei de sânge. The invention relates to medicine and can be used to prevent infection with the hepatitis B virus as a result of blood transfusion.
Este cunoscută metoda de testare a sângelui donat la markerii hepatitei virale В prin reacţia imunoenzimatică, care include testarea la AgHBs, anticorpii AntiHBcor sumari şi AntiHBs [1]. Depistarea 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 В prezent în toate fazele bolii începând cu etapa acută (MD 34 Y 2009.06.30). Anticorpii AntiHBs indică prezenţa imunităţii naturale sau postvaccinale la această infecţie. Conform algoritmului cunoscut sângele donat se testează în prima etapă la antigenul AgHBs, dacă rezultatul este pozitiv sângele este rebutat, dacă rezultatul este negativ sângele se testează la AntiHBcor sumar şi AntiHBs în scopul depistării hepatitei virale В oculte (hepatita virală В AgHBs negativă), incidenţa căreia poate constitui până la 15% din cazuri la persoane pozitive la markerul AntiHBcor sumar (Allain J.P. Occult hepatitis В virus infection. Transfus. Clin. Biol. 2004 Feb.,11 (1), p. 18-20), (Mauss, Berg, Rockstroh, Sarrazin, Wedemeyer, "Hepatology A Clinical Textbook", Edition 2012). În caz de rezultat negativ la AntiHBcor sumar, sângele donat este validat pentru utilizare, dacă rezultatul este pozitiv sângele se testează la AntiHBcor IgM. În caz de rezultat pozitiv sângele este rebutat, iar în cazul rezultatului negativ sângele se testează la AntiHBs. Dacă concentraţia AntiHBs este mai mare de 100 mUI/ml sângele este validat pentru utilizare pentru transfuzie, dacă concentraţia AntiHBs este mai mică de 100 mUI/ml, sânge este rebutat. The method of testing donated blood for markers of viral hepatitis В by immunoenzymatic reaction is known, which includes testing for AgHBs, AntiHBcor antibodies and AntiHBs [1]. 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 В present in all phases of the disease, starting with the acute stage (MD 34 Y 2009.06.30). 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, if the result is positive, the blood is rejected, if the result is negative, the blood is tested for AntiHBcor sum and AntiHBs in order to detect occult viral hepatitis В (viral hepatitis В AgHBs negative), the incidence of which can constitute up to 15% of cases in people positive for the AntiHBcor sum marker (Allain J.P. Occult hepatitis В virus infection. Transfus. Clin. Biol. 2004 Feb.,11 (1), p. 18-20), (Mauss, Berg, Rockstroh, Sarrazin, Wedemeyer, "Hepatology A Clinical Textbook", Edition 2012). In case of a negative result for AntiHBcor sum, the donated blood is validated for use, if the result is positive, the blood is tested for AntiHBcor IgM. In case of a positive result, the blood is rejected, and in case of a negative result, the blood is tested for AntiHBs. If the AntiHBs concentration is greater than 100 mIU/ml, the blood is validated for use for transfusion; if the AntiHBs concentration is less than 100 mIU/ml, the blood is rejected.
De asemenea, este cunoscută metoda de determinare a markerilor hepatitei virale B în sângele donatorului, care 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 Anti HBcor sumari, în cazul unui rezultat negativ sângele donatorului poate fi utilizat pentru transfuzii, iar când rezultatul este pozitiv în sânge se determină markerii Anti HBcor IgM, dacă rezultatul este pozitiv sângele nu poate fi utilizat pentru transfuzii, iar când rezultatul este negativ în sânge se determină markerii Anti HBs, 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. Also, the method of determining markers of viral hepatitis B in the donor's blood is known, which consists in determining the HBs antigen in the said 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 Anti HBcor markers, 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 Anti HBcor IgM markers are determined, if the result is positive the blood cannot be used for transfusions, and when the result is negative in the blood the Anti HBs markers are determined, if the antibody concentration is less than 100 mIU/ml the blood cannot be transfused, and when the antibody concentration is greater than 100 mIU/ml the blood can be used for transfusions.
Dezavantajele acestor metode constau în aceea ca aplicarea algoritmului nominalizat nu permite detectarea tuturor cazurilor de hepatită virală В ocultă, ca urmare există pericolul de transmitere a virusului hepatitei В prin transfuzie de sânge. Conform datelor literaturii în ţările endemice chiar şi în cazul concentraţiei AntiHBs mai mare de 100 UI/l sângele poate fi potenţial infecţios. Ponderea cazurilor de decelare a ADN.VHB la donatorii de sânge ce au anticorpi anti-HBs cu un titru mai mare de 100 UI/1 variază de la 0,7% până la 4,5% (Alizadeh Z., Saeideh M., Milani M. Occult hepatitis В virus infection among iranian blood donors: A Preliminary Study. Arch. Iran. Med. 2014, 17(2), p. 106 -107), (Manzini P., Girotto M., Borsotti R. Italian blood donors with anti-HBc and occult hepatitis В virus infection. Haematologica, 2007, 92, p. 1664-1670), (Hennig H., Puchta L., Luhm J. et al. Frequency and load of hepatitis В virus DNAin first-time blood donors with antibodies to hepatitis В core antigen. The American Society of Hematology, 1 October 2002, vol. 100, nr. 7, p. 2637-2641), (Kaminski G., Alnaqdy A., Al-Belushi I. et al. Evidence of occult hepatitis В virus infection among Omani blood donors: a preliminary study. In: Med. Princ. Pract., 2006, 15, p. 368-372), (Said Z. N., ElSayed H., Salama L.I. et al. Occult hepatitis "B" virus infection among egyptian blood donors. World J Hepatol. 2013 Feb 27, 5(2), p. 64-73), în sursele menţionate au fost descrise cazuri când ADN-ul viral a fost evidenţiat la persoane cu titrul anticorpilor AntiHBs mai mare de 1000 UI/l (Kaminski G., Alnaqdy A., Al-Belushi I. et al. Evidence of occult hepatitis В virus infection among Omani blood donors: a preliminary study. In: Med. Princ. Pract., 2006, 15, p.368-372). The disadvantages of these methods are that the application of the named algorithm does not allow the detection of all cases of occult viral hepatitis В, as a result of which there is a danger of transmission of hepatitis В virus through blood transfusion. According to the literature data in endemic countries even in the case of AntiHBs concentration higher than 100 IU/l the blood can be potentially infectious. The proportion of cases of detection of HBV DNA in blood donors with anti-HBs antibodies with a titer greater than 100 IU/l varies from 0.7% to 4.5% (Alizadeh Z., Saeideh M., Milani M. Occult hepatitis В virus infection among Iranian blood donors: A Preliminary Study. Arch. Iran. Med. 2014, 17(2), p. 106 -107), (Manzini P., Girotto M., Borsotti R. Italian blood donors with anti-HBc and occult hepatitis В virus infection. Haematologica, 2007, 92, p. 1664-1670), (Hennig H., Puchta L., Luhm J. et al. Frequency and load of hepatitis В virus DNAin first-time blood donors with antibodies to hepatitis В core antigen. The American Society of Hematology, 1 October 2002, vol. 100, no. 7, p. 2637-2641), (Kaminski G., Alnaqdy A., Al-Belushi I. et al. Evidence of occult hepatitis В virus infection among Omani blood donors: a preliminary study. In: Med. Princ. Pract., 2006, 15, p. 368-372), (Said Z. N., ElSayed H., Salama L.I. et al. Occult hepatitis "B" virus infection among Egyptian blood donors. World J Hepatol 2013, 5(2), p. 64-73), the mentioned sources described cases when viral DNA was detected in people with AntiHBs antibody titers higher than 1000 IU/l (Kaminski G., Alnaqdy A., Al-Belushi I. et al. Evidence of occult hepatitis В virus infection among Omani blood donors: a preliminary study. In: Med. Princ. Pract., 2006, 15, p.368-372).
Tabelul 1 Table 1
Studii şi rezultate privind frecvenţa decelării ADN VHB la donatorii primari de sânge pozitivi la AntiHBc sum. şi la AntiHBs cu titru mai mare de 100 mUI/ml Studies and results regarding the frequency of HBV DNA detection in primary blood donors positive for AntiHBc sum. and AntiHBs with titer higher than 100 mIU/ml
Studiu Nr. donatori testaţi Poz. AntiHBc sum. % Poz. AntiHBs > 100 mUI/m1 % Poz. ADN VHB % Said Zeinab N. et al., 2013 3167 525 16,57 239 45,5 6 2,5 Kaminski G. et al., 2006 200 41 20,5 22 53,7 1 4,5 Hennig H. et al., 2002 14251 216 1,52 144 66,7 3 2,1 Manzini P. et al., 2007 6313 305 4,83 266 87,2 6 2,2 Alizadeh Z. et al., 2014 5000 499 9,98 275 55,1 2 0,7 Total 28931 1586 5,48 946 59,6 18 1,9Study No. of donors tested AntiHBc pos. sum. % AntiHBs pos. > 100 mIU/m1 % Pos. HBV DNA % Said Zeinab N. et al., 2013 3167 525 16.57 239 45.5 6 2.5 Kaminski G. et al., 2006 200 41 20.5 22 53.7 1 4.5 Hennig H. et al., 2002 14251 216 1.52 144 66.7 3 2.1 Manzini P. et al., 2007 6313 305 4.83 266 87.2 6 2.2 Alizadeh Z. et al., 2014 5000 499 9.98 275 55.1 2 0.7 Total 28931 1586 5.48 946 59.6 18 1.9
Problema pe care o rezolvă invenţia este reducerea maximală a riscului până la excluderea posibilităţii transmiterii hepatitei virale В prin transfuzie de sânge de la donatorii de sânge cu hepatită virală В ocultă. The problem solved by the invention is the maximum reduction of the risk to the exclusion of the possibility of transmission of viral hepatitis В through blood transfusion from blood donors with occult viral hepatitis В.
Esenţa invenţiei constă în aceea că în sânge se determină succesiv prezenţa antigenului AgHBs, anticorpilor antiHBcor sumar, antiHBcor IgM şi antiHBs, iar pentru sângele cu titrul la antiHBs mai mare de 100 mUI/ml, suplimentar se efectuează testul la ADN al virusului hepatitei B şi în cazul în care testul este pozitiv, se stabileşte prezenţa markerilor hepatitei virale B în sângele donatorului. The essence of the invention is that the presence of AgHBs antigen, total antiHBcor antibodies, antiHBcor IgM and antiHBs is determined in the blood successively, and for blood with an antiHBs titer higher than 100 mUI/ml, an additional hepatitis B virus DNA test is performed and if the test is positive, the presence of hepatitis B viral markers in the donor's blood is established.
Rezultatul obţinut constă în obţinerea unui nou algoritm de testare a sângelui donat la markerii hepatitei virale B, în special la ADN VHB, care exclude de la transfuzie produsele de sânge ale persoanelor cu markerul AntiHBs pozitiv cu titrul mai mare de 100 mUI/ml cu urme ale ADN-ului virusului hepatitei B. The result obtained consists of obtaining a new algorithm for testing donated blood for markers of viral hepatitis B, especially HBV DNA, which excludes from transfusion blood products of people with a positive AntiHBs marker with a titer greater than 100 mIU/ml with traces of hepatitis B virus DNA.
Argumentarea metodei propuse se bazează pe extrapolarea datelor din literatura de specialitate la rezultatele obţinute în ţară în ceea ce priveşte testarea donatorilor de sânge la markerul AntiHBs în cadrul Centrului Naţional de Transfuzie a Sângelui pe parcursul anului 2015. În total au fost testaţi 78769 donatori de sânge conform algoritmului propus la markerii AntiHBcor sumar, cei pozitivi la acesta - 23866 au fost testaţi la markerul AntiHBs. Rezultatele testărilor sunt prezentate în tab. 2. The argumentation of the proposed method is based on the extrapolation of data from the specialized literature to the results obtained in the country regarding the testing of blood donors for the AntiHBs marker within the National Blood Transfusion Center during 2015. In total, 78769 blood donors were tested according to the proposed algorithm for the AntiHBcor summary markers, of those positive for it - 23866 were tested for the AntiHBs marker. The results of the tests are presented in tab. 2.
Tabelul 2 Table 2
Rezultatele testării sângelui donat la markerii hepatitei virale B Results of testing donated blood for markers of viral hepatitis B
Markeri Total investigaţi Rezultat Ponderea, % Anti HBcor sumar 78769 pozitiv negativ pozitiv negativ 23866 54903 30,3 69,7 Anti HBs 23866 >100 mUI/ml <100 mUI/ml >100 mUI/ml <100 mUI/ml 12633 11233 52,9 47,1Markers Total investigated Result Weight, % Anti HBcor summary 78769 positive negative positive negative 23866 54903 30.3 69.7 Anti HBs 23866 >100 mIU/ml <100 mIU/ml >100 mIU/ml <100 mIU/ml 12633 11233 52.9 47.1
Rezultatele obţinute demonstrează că 30,3% din probe sunt pozitive la markerul AntiHBcor sumar. Din aceste probe pozitive la AntiHBcor sumar 52,9% demonstrează un număr de anticorpi AntiHBs mai mare de 100 mUI/ml de sânge şi conform algoritmului existent recomandat (Screening Donated Blood for Transfusion Infections, WHO, 2009) sunt validate pentru donare. Restul 47,1% de probe cu cantitatea AntiHBs mai mică de 100 mUI/ml sânge este exclus din donare. În continuare dacă vom extrapola rezultatele obţinute din literatura de specialitate care denotă faptul că printre cei pozitivi la markerul anti-HBs cu titrul mai mare de 100 mUI/ml ponderea celor cu potenţial infecţios manifestat de prezenţa ADN VHB variază între 0,7% şi 4,5%, pentru ţara noastră vom obţine că printre cei 12633 donatori pozitivi la markerul AntiHBs cu titrul mai mare de 100 mUI/ml este posibil să existe între 88 şi 568 persoane care prezintă risc infecţios prin prisma posibilei prezenţe a ADN-ului viral, marker al persistenţei infecţiei virale cu virusul hepatitei virale B, utilizarea metodei propuse va permite de a optimiza identificarea donatorilor cu hepatită В ocultă activă, astfel prevenind transfuzia de sânge de la aceştia. Testarea la ADN VHB a probelor pozitive la markerul AntiHBs cu titrul mai mare de 100 mUI/ml, care prezumtiv erau validate pentru donare, va permite diagnosticarea exactă a hepatitei virale В oculte la aceste persoane, cu excluderea lor din categoria de donator şi suspendarea utilizării sângelui (inclusiv a produselor obţinute din el) recoltat de la ei. Aşadar, metoda propusă asigură un nivel maxim posibil de securitate transfuzională comparativ cu cel prezentat în cea mai apropiată soluţie. The results obtained demonstrate that 30.3% of the samples are positive for the AntiHBcor summary marker. Of these samples positive for AntiHBcor summary, 52.9% demonstrate a number of AntiHBs antibodies greater than 100 mIU/ml of blood and according to the existing recommended algorithm (Screening Donated Blood for Transfusion Infections, WHO, 2009) are validated for donation. The remaining 47.1% of samples with the AntiHBs amount less than 100 mIU/ml of blood are excluded from donation. Further, if we extrapolate the results obtained from the specialized literature which show that among those positive for the anti-HBs marker with a titer higher than 100 mIU/ml, the share of those with infectious potential manifested by the presence of HBV DNA varies between 0.7% and 4.5%, for our country we will obtain that among the 12,633 donors positive for the AntiHBs marker with a titer higher than 100 mIU/ml, there may be between 88 and 568 people who present an infectious risk in terms of the possible presence of viral DNA, a marker of the persistence of viral infection with the hepatitis B virus. The use of the proposed method will allow us to optimize the identification of donors with active occult hepatitis B, thus preventing blood transfusion from them. Testing for HBV DNA of samples positive for the AntiHBs marker with a titer higher than 100 mIU/ml, which were presumably validated for donation, will allow for the accurate diagnosis of occult viral hepatitis В in these individuals, with their exclusion from the donor category and suspension of the use of blood (including products obtained from it) collected from them. Therefore, the proposed method ensures the maximum possible level of transfusion safety compared to that presented in the closest solution.
1. Screening Donated Blood for Transfusion Infections. WHO, 2009 1. Screening Donated Blood for Transfusion Infections. WHO, 2009
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU712091A1 (en) * | 1978-07-31 | 1980-01-30 | Рижский Медицинский Институт | Method of detecting antigens or antibodies e of hepatitis b viruses |
| SU1642399A1 (en) * | 1988-12-27 | 1991-04-15 | Институт Органического Синтеза Ан Латвсср | Method for determination of antibodies class igm for corantigen of hepatitis b virus |
| SU1704088A1 (en) * | 1989-06-27 | 1992-01-07 | Нижегородский государственный медицинский институт им.С.М.Кирова | Method for forecasting chronic viral hepatitis b |
| SU1711676A3 (en) * | 1987-02-20 | 1992-02-07 | Zeeling Renate | Method of dna isolation for diagnosis of non-a,non-b- hepatitis |
| SU1751680A1 (en) * | 1990-03-11 | 1992-07-30 | Нижегородский медицинский институт им.С.М.Кирова | Method for prognostication of chronic hepatitis b development |
| 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 |
| MD975Y (en) * | 2015-01-28 | 2015-12-31 | Centrul Naţional De Sănătate Publică Al Ministerului Sănătăţii Al Republicii Moldova | Method for donor blood testing for hepatitis B virus markers |
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Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU712091A1 (en) * | 1978-07-31 | 1980-01-30 | Рижский Медицинский Институт | Method of detecting antigens or antibodies e of hepatitis b viruses |
| SU1711676A3 (en) * | 1987-02-20 | 1992-02-07 | Zeeling Renate | Method of dna isolation for diagnosis of non-a,non-b- hepatitis |
| SU1642399A1 (en) * | 1988-12-27 | 1991-04-15 | Институт Органического Синтеза Ан Латвсср | Method for determination of antibodies class igm for corantigen of hepatitis b virus |
| SU1704088A1 (en) * | 1989-06-27 | 1992-01-07 | Нижегородский государственный медицинский институт им.С.М.Кирова | Method for forecasting chronic viral hepatitis b |
| SU1751680A1 (en) * | 1990-03-11 | 1992-07-30 | Нижегородский медицинский институт им.С.М.Кирова | Method for prognostication of chronic hepatitis b development |
| 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 |
| MD975Y (en) * | 2015-01-28 | 2015-12-31 | Centrul Naţional De Sănătate Publică Al Ministerului Sănătăţii Al Republicii Moldova | Method for donor blood testing for hepatitis B virus markers |
Non-Patent Citations (1)
| Title |
|---|
| Screening Donated Blood for Transfusion Infections. WHO, 2009 * |
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