HCV RNA and HIV RNA detection by Procleix HIV-1/HCV Assay in blood donors with various results of anti-HCV and anti-HIV EIA

Wstęp: Celem pracy była ocena czułości wykrywania RNA HIV i RNA HCV metodą Procleix HIV1/HCV oraz analiza częstości wykrywania materiału genetycznego wirusów u dawców z różnymi wynikami testów przeglądowych anty-HCV i anty-HIV. Materiał i metody:Dziewięćdziesięciopięcioprocentowa czułość testu Procleix wynosiła 6,2 IU RNA HCV /ml i 44,5 IU RNA HIV /ml. RNA HCV wykryto w 71/392 (18,1%) dodatnich próbkach anty-HCV, zaś RNA HIV w 21/557 (3,8%) próbkach reaktywnych w badaniu EIA HIV. Częstość wykrywania RNA HCV korelowała z wartością S/C uzyskaną w badaniach immunoenzymatycznych. RNA HCV wykryto u 68/105 (64,8%) dawców z S/C > 4, u 1/85 (1,2%) z S/C od 2,00 do 3,99 i u 2/202 dawców (1%) z S/C od 1,00 do 1,99. RNA HIV wykryto u wszystkich 21 dawców z dodatnimi wynikami zarówno w badaniu EIA, jak i w Western Blot. Wyniki i wnioski: Procleix HIV1/HCV jest bardzo czułym testem i może być wykorzystywany w laboratorium referencyjnym do potwierdzania aktywnego zakażenia u dawców z dodatnim wynikiem immunoezymatycznych badań przeglądowych. Obserwowano małą częstość aktywnych zakażeń u dawców z powtarzalnie dodatnimi wynikami badań anty-HCV i anty-HIV. Wysoka wartość S/C (> 4) w EIA jest dobrym czynnikiem prognostycznym wykrycia RNA HCV, aczkolwiek RNA HCV może być sporadycznie wykrywane u dawców z niższą wartością S/C w EIA.Background: The aim of the study was to investigate the sensitivity of Procleix HIV1/HCV Assay for HIV RNA and HCV RNA detection, and to analyse the frequency of viral nucleic acid detection in blood donors with various EIA test results. Material and methods: The 95% sensitivity of the Procleix test was 6.2 IU HCV RNA /ml and 44.5 IU HIV RNA /ml. HCV RNA was detected in 71/392 (18.1%) anti-HCV positive and HIV RNA in 21/557 (3.8%) EIA HIV-reactive donors. The frequency of HCV RNA detection correlated with signal/cut-off ratios (S/C ratio) of EIA. HCV RNA was found in 68/105 (64.8%) of the donors if it was >4, in 1/85 (1.2%) if it was between 2.00 and 3.99, and in 2 out of 202 donors (1%) if it was between 1.00 and 1.99. HIV RNA was detected in all 21 blood donors positive in EIA and Western Blot. Results and conclusions: The study demonstrated that Procleix HIV1/HCV Assay is very sensitive and can be used in the reference laboratory to confirm active infection in donors with positive results. We observed a low frequency of active infection in Polish blood donors with repeated reactive results in HCV and HIV EIA. The high S/C ratio value (> 4) of EIA is a good predictor of HCV RNA detection, but HCV RNA can also be detected in single donors with low ratio values of the EIA test

Multiple sclerosis: oral health, behaviours and limitations of daily oral hygiene — a questionnaire study

Clinical rationale for the study. Neurological deficits and progressing disability in patients with multiple sclerosis (MS) may hamper daily oral hygiene, but their relations with oral problems have not yet been clearly determined.Aim of the study. The aim of this study was to identify the most significant dental problems and limitations of daily oral hygiene in Polish patients with MS.Material and methods. 199 patients with diagnosed MS (median age 37 years) treated in the neurological outpatient clinic were interviewed using a paper-based questionnaire. They provided answers on oral health, behaviours and the limitations of their daily oral hygiene. Clinical information regarding symptoms, MS phenotype, relapses, medication and degrees of disability was based on medical records.Results. The most frequent symptoms were dry mouth (43.2%) and bleeding from gums (28.1%). Dry mouth was more frequent in patients with secondary-progressive MS (SPMS) than relapsing-remitting MS (65.4% vs 41.3%, p = 0.023). Patients with bleeding from gums had had MS for a longer duration (median 6 vs 4 years, p = 0.002). Difficulties in daily oral hygiene were more frequent in patients with SPMS (24.0% vs 8.1%; p = 0.016). Greater proportions of patients with muscle weakness of limbs, imbalance or pain brushed their teeth irregularly. Frequent (i.e. at least every six months) visits to the dentist’s surgery were uncommon in patients with SPMS (12.0% vs 39.7%, p = 0.010).Conclusions and clinical implications. Dry mouth and bleeding from gums are more frequent in patients with longer lasting and more advanced types of MS. Daily oral hygiene and oral health self-control is limited in patients with MS, mainly due to motor deficits, balance problems and pain, and this becomes worse with disease duration. To minimise the burden of the disease, patients with MS require better education and improvement in their awareness regarding proper oral health control, such as the use of electric toothbrushes. In addition, patients with chronic and progressive disability from multiple sclerosis may benefit from better organised access to dental care

Zmiany demograficzne obserwowane w grupie polskich dawców zakwalifikowanych do oddania krwi i objętych badaniami przeglądowymi w kierunku czynników zakaźnych w latach 2005-2018

Wstęp: Dotychczas wykazano, że częstość zakażeń wśród dawców zakwalifikowanych do oddania krwi i objętych badaniami przeglądowymi, a w konsekwencji ryzyko powikłań potransfuzyjnych wiążą się z charakterystyką demograficzną dawców. Celem pracy było ustalenie zmian demograficznych wśród polskich dawców zakwalifikowanych w latach 2005–2018 do oddania krwi i objętych badaniami przeglądowymi w kierunku czynników zakaźnych. Uzyskane wyniki interpretowano w kontekście bezpieczeństwa transfuzji, a zwłaszcza ryzyka przenoszenia czynników zakaźnych przez krew. Materiał i metody: Analizowano dane gromadzone między innymi do oceny epidemiologii czynników zakaźnych przenoszonych przez krew: liczbę przebadanych dawców zakwalifikowanych do oddania krwi z podziałem na płeć, dawców pierwszorazowych i wielokrotnych oraz grupy wiekowe (≤ 20, 21–30, 31–40, 41–50, 51–60 i > 60 lat). Częstość (frakcję) wyrażano w procentach z 95-procentowym przedziałem ufności [95%CI], a różnice za pomocą punktu procentowego (p.p.). Istotność różnic (p < 0,05) weryfikowano za pomocą testu Chi-kwadrat, do oceny trendu stosowano współczynnik korelacji Spearmana (R). Wyniki: Większość dawców stanowili mężczyźni (średnio 74,07%), jednak w latach 2005–2012 udział kobiet wzrósł o 7 p.p. do 27,42% [27,30–27,53%] (p < 0,05); wśród dawców pierwszorazowych o 10,58 p.p., a wielokrotnych o 7,19 p.p. Największy udział kobiet obserwowano wśród najmłodszych dawców (36,02% [35,95–36,09%]), a najniższy wśród najstarszych dawców (14,14% [13,80–14,48%]) (różnica 21,88 p.p.; p < 0,05). Większość dawców krwi stanowili dawcy wielokrotni (średnio 66,78%). Udział dawców wielokrotnych wzrósł łącznie o 19,83 p.p. (p < 0,05): o 20,6 p.p. u mężczyzn i 21,15 p.p. u kobiet (dla obu grup p < 0,05). We wszystkich grupach wiekowych, z wyjątkiem dawców najmłodszych, większość (p < 0,05) stanowili dawcy wielokrotni. Udział dawców wielokrotnych rósł w kolejnych grupach wiekowych — od 36% u najmłodszych (≤ 20 lat) do 87% u dawców najstarszych (> 60 lat). Udział dawców w wieku > 40 lat zwiększył się o 11,58 p.p od 37,38% do 48,96%. Wnioski: W latach 2005–2018 obserwowano istotne zmiany demograficzne w grupie polskich dawców zakwalifikowanych do oddania krwi i objętych badaniami przeglądowymi, m.in. wzrósł udział kobiet oraz dawców wielokrotnych, co z punktu widzenia bezpieczeństwa transfuzji jest zjawiskiem korzystnym

Demographic changes in the Polish blood donors eligible for blood donation and screened for transfusion-transmitted infections (2005–2018)

Background: The infection frequency among donors found eligible for donation (based on donor questionnaire and physical examination) and therefore the risk of post-transfusion adverse reactions has been demonstrated to be closely related to donor demographics. The aim of the study was to determine the demographic changes among Polish blood donors found eligible for donation and subjected to screening for infectious markers in the years 2005–2018. The results were referred to transfusion safety, and particularly to the risk of transfusion-transmitted infectious agents.  Material and methods: Subjected to analysis were data collected i.a. to assess the epidemiology of blood-borne infectious agents: the number of screened donors found eligible for donation divided into categories by sex, first and repeat donation as well as age groups (≤ 20, 21–30, 31–40, 41–50, 51–60 and > 60 years). Frequencies (fraction) were expressed as percentage with a 95% confidence interval [95%CI] and the differences — as percentage point (p.p.). The significance of difference (p < 0.05) was verified by the Chi-squared test, and the Spearman correlation coefficient (R) was used to assess the trend. Results: Most donors were men (74.07% on average) but in the years 2005–2012 the number of women increased by 7 p.p. up to 27.42% [27.30–27.53%] (p < 0.05); by 10.58 p.p among first-time donors and by 7.19 p.p. among repeat donors. The highest frequency of women was observed in the population of the youngest age group (36.02% [35.95–36.09%]) and the lowest among the oldest age group of donors (14.14% [13.80–14.48%]) (difference 21.88 p.p.; p < 0.05). The majority were repeat donors (66.78% on average). The frequency of repeat donors increased by a total of 19.83 p.p. (p < 0.05): by 20.6 p.p. for men and by 21.15 p.p. for women (p < 0.05 for both groups). In all age groups, except the youngest, the majority (p < 0.05) were repeat donors. The frequency of repeat donors increased in subsequent age groups — from 36% in the youngest (≤ 20 years) to 87% in the oldest donors ( > 60 years). The frequency of donors > 40 years increased by 11.58 p.p. from 37.38% to 48.96%. Conclusions: In the years 2005–2018, significant demographic changes were observed in the population of Polish donors; the frequency of women donors and repeat donors increased, with benefit for transfusion safety.Background: The infection frequency among donors found eligible for donation (based on donor questionnaire and physical examination) and therefore the risk of post-transfusion adverse reactions has been demonstrated to be closely related to donor demographics. The aim of the study was to determine the demographic changes among Polish blood donors found eligible for donation and subjected to screening for infectious markers in the years 2005–2018. The results were referred to transfusion safety, and particularly to the risk of transfusion-transmitted infectious agents. Material and methods: Subjected to analysis were data collected i.a. to assess the epidemiology of blood-borne infectious agents: the number of screened donors found eligible for donation divided into categories by sex, first and repeat donation as well as age groups (≤ 20, 21–30, 31–40, 41–50, 51–60 and > 60 years). Frequencies (fraction) were expressed as percentage with a 95% confidence interval [95%CI] and the differences — as percentage point (p.p.). The significance of difference (p 60 years). The frequencyof donors > 40 increased by 11.58 p.p. from 37.38% to 48.96%. Conclusions: In the years 2005–2018, significant demographic changes were observed in the population of Polish donors; the frequency of women donors and repeat donors increased, with benefit for transfusion safety

Progress in the search for blood substitutes, part 1 Preparations currently used in haemotherapy as an indicator of new drug development

The hospital pharmacy in polish conditions, rarely participates in the logistic process related to the transport, storage and administration of blood, however, it is involved in supplying the hospital with a variety of blood products and blood substitutes such as crystalloids, colloids and albumins. The awareness of logistic and technological problems, as well as the analysis of costs, legal and ethical restrictions related to the use of blood products, becomes essential for good, effective, merit-based cooperation between a clinical pharmacist and other health care specialists. Introducing a good blood substitute would solve the problem of donating blood, costly storage, transport and testing. Due to the specific nature of the blood administration procedure, it cannot be used in some situations for ethical and religious reasons. Current research in the search for blood substitutes does not focus on the exact reconstitution of blood with its cellular components. While it seems impossible to create a perfect preparation, products intended to partially replace the role of blood have a greater chance of being used. Examples include not only preparations for filling the vascular bed, but also a variety of oxygen carriers. It should be noted that the use of cell-free preparations solves numerous technological problems related to the use and administration of blood products. The lack of proteins in the product supporting the transport of oxygen and carbon dioxide in human tissues or medical equipment means no risk of allergic reactions, coagulation and the need to conduct tests before administration of the drug, which improves access to therapy by reducing technological problems, and increases the level of patient safety and allows you to improve the effectiveness of the therapeutic process. The series of articles will present the current state of the art, directions of research and development possibilities of blood products and blood substitutes, with particular reference to acellular oxygen transfer agents

Charakterystyka testu cobas® MPX wraz z analizatorem cobas® 6800 oraz aparatem cobas p 680 (Roche) przeznaczonych do automatycznego badania dawców krwi w kierunku RNA wirusa zapalenia wątroby typu C (HCV), RNA ludzkiego wirusa nabytego niedoboru odporności (HIV) i DNA wirusa zapalenia wątroby typu B (HBV)

Background. The cobas MPX test for use with the cobas 6800 System is a qualitative, real-time PCR test for the detection of HIV-1 Groups M and O RNA, HIV-2 RNA, HCV RNA and HBV DNA in human plasma and serum. The test simultaneously identifies HIV, HCV and HBV (multiplex). Optional component to the cobas 6800 System is the cobas p 680 instrument that creates pools from individual samples. Aim. To evaluate the cobas MPX test in individual donations and in plasma pools using the cobas p 680 instrument. Material and methods. Analytical sensitivity was assessed with serial dilutions of the WHO International Standards (IS): HCV, HIV-1, HIV-2, HBV and Performance Panel HIV-1 (O) (Sera Care). Correct identification of reactive donations was evaluated by testing 473 negative and 7 reactive donations in minipools (≤ MP6). Results. Limits of detection (with 95% confidence limits) of cobas MPX were 7.12 IU/mL (4.40–15.62), and 31.33 IU/mL (17.84–76.80) for HCV and HIV-1, respectively. For HBV it was related to dilutions used for Probit analysis and equaled 3.97 IU/mL (2.25–9.75): 1,33 IU/mL (0,89–4,25); 2,05 IU/mL (1.45–3.40). All dilutions of the HIV-1 group O (100–10 copies/mL) and HIV-2 (31.6–10 IU/mL) samples were detected. Results of MPX tests imitating blood screening with the cobas6800 system were in accordance with expected results. Overall, false reactive rates for pooled samples were 0.1%. Conclusions. The cobas MPX test on the cobas 6800 System, including the cobas p 680 instrument demonstrated high sensitivity and satisfactory specificity required in Polish blood donation system. The cobas MPX test correctly identified infected donations without a significant risk of false results.Wstęp. Test cobas® MPX przeznaczony jest do badań przeglądowych krwiodawców na obecność kwasów nukleinowych wirusa zapalenia wątroby typu C (HCV), B (HBV) oraz ludzkiego wirusa niedoboru odporności (HIV) w analizatorze cobas® 6800. Jest to jakościowy test multiplex, wykorzystujący metodę łańcuchowej reakcji polimerazy z analizą w czasie rzeczywistym (RT PCR). Opcjonalnym elementem systemu jest cobas p 680 — zautomatyzowane urządzenie pipetujące do pulowania próbek.Cel. Ocena przydatności testu cobas® MPX do badań przeglądowych krwiodawców.Materiały i metody. Czułość analityczną określano, badając w powtórzeniach rozcieńczenia międzynarodowych standardów (IS) WHO: HCV, HIV-1, HIV-2 i HBV oraz Performance Panel HIV-1 (O) (Sera Care). Poprawność identyfikacji wirusów oceniano, badając: pojedynczo (IDT) 14 seronegatywnych próbek zawierających materiał genetyczny (NAT yield) oraz w minipulach 480 próbek: 473 ujemnych i 7 NAT yield.Wyniki. Czułość analityczna testu cobas® MPX na poziomie 95% wykrywalności [LOD] (95% przedział ufności) wynosiła odpowiednio dla HCV — 7,12 IU/ml (4,40–15,62); HIV — 31,33 IU/ml (17,84–76,80), natomiast dla HBV zależała od doboru rozcieńczeń do analizy Probit — 3,97 IU/ml (2,25–9,75); 2,05 IU/ml (1,45–3,40); 1,3 IU/ml (0,89–4,25). Wyniki reaktywne uzyskano we wszystkich próbkach rozcieńczeń o stężeniach 100–10 kopii/ml oraz31,6 i 10 IU/ml, odpowiednio, HIV-1 grupy O i HIV-2. Wyniki badań imitujących badania przeglądowe z zastosowaniem testów cobas® MPX były zgodne z wynikami spodziewanymi, a częstość wyników fałszywie reaktywnych wynosiła 0,1%.Wnioski. Test cobas® MPX wykazuje czułość i swoistość wymaganą dla testów przeglądowychNAT stosowanych w polskim krwiodawstwie. Użycie testu na aparacie cobas® 6800 wraz z cobas p680 umożliwia prawidłową identyfikację zakażonej donacji bez istotnego ryzyka występowania wyników fałszywych