IMPROVEMENT OF THE QUALITY CONTROL OF ELISA TESTING FOR THE LABORATORY CONFIRMATION OF MEASLES AND RUBELLA INFECTIONS AT THE STAGE OF THE MEASLES/ RUBELLA ELIMINATION PROGRAM

Cover Page


Cite item

Full Text

Abstract

To estimate ELISA serological studies results of IgM and IgG specific Measles and Rubella Viruses (MRV) antibodies detection the “in-house” laboratory controls (ILC) including the specific markers of MRV infections were for the first time commercially prepared by the Vector Best PLC (Russia): “Measles-IgM, ser.1”, “Measles-IgM, ser.2”, “Rubella-IgM”, Measles-IgG” and “Rubella-IgG”. This task was realized under the special Executive Order of the Government of Russia N 523-r, 2014, April, 4. According to passport characteristics ILC samples are the lyophilized human sera, inactivated by heating (1 hour at 56°C) and stabilized by the mixture of sucrose (5%) and ProClin-3000 as the conservation agent. Samples are free of HBs Ag, anti-HVC, T.Pallidum, HIV-1/2, HIV-1Ag р24.The aim of the study was to evaluate the possibility of using the ILC for detection of the MRV IgM and IgG antibodies by ELISA with commercial ELISA kits used in Russia and CIS countries. In the process of detecting the specific activity of “Measles-IgM, ser.1”, “Measles-IgM, ser.2” and “Rubella-IgM” by ELISA kits of different formats (Vector Best, EcoLab and Siemens Companies) the statistically different results were received (p < 0.05). The optical density (OD) values of IgM in the “Measles-IgM, ser.1” and “Measles-IgM, ser.2” ILC, obtained by ELISA “VectoMeasles IgM” (Vector Best) were significantly higher than those obtained by ELISA IgEnzygnost®Anti-MeaslesVirus/IgМ. These values consisted for the ser. 1–1.33±0.02 о.u. vs. 0.18±0.01 о.u. (р < 0.05) and for the ser. 2–2.83±0.03 о.u. vs. 0.7±0.02 о.е. (р < 0.05) in the Vector Best and Siemens ELISA kits correspondently. In the “Rubella-IgM” ILC the OD values of the specific IgM by the “ELISA-Rubella IgM” EcoLab were also higher than those obtained by IgEnzygnost®Anti-RubellaVirus/IgМ ELISA kit. These values consisted 2.92±0.04 о.u. vs. 0.88±0.03 о.u. (р < 0.05) in EcoLab and Siemens ELISA test-systems correspondently. In the studies when the ILC working solution parameters for ELISA of “capture” and “indirect” formats were evaluated the statistic reliability and high information capability of the mathematic models of the OD value changes vs. the degree of dilution of the initial ILC were determined. For the “capture” and “indirect” formats the determination coefficient (R2) consisted 97.34 and 99.29 correspondently, the Fisher criteria (F) — 219.62 and 556.55 correspondently, the significance level (p) — < 0.05 for both formats. The evaluated optimal working dilution degrees of the IgM-containing ILC make possible to exclude the influence of the IgG antibodies as the non-target marker in the ILC. On the other hand, taking into account the format of the used ELISA kit the optimal working dilution degrees give the possibility to obtain the desirable 2–3 “cut-off” values of the specific marker. Moreover, the issue of the target marker quantitative content in ILC is discussed in the study. In order to improve the quality of the commercial MRV IgM and IgG ELISA test-systems the joint studies with those who develop and produce these systems are desirable to be organized.

About the authors

T. A. Mamaeva

Gabrichevsky Research Institute for Epidemiology and Microbiology

Author for correspondence.
Email: 4522826@bk.ru

PhD (Biology), Leading Researcher, Laboratory of Immunochemistry

125212, Russian Federation, Moscow, Admiral Makarov str.,10, Phone: +7 (495) 452-28-26 (office); +7 903 558-10-70 (mobile)

Россия

N. V. Zheleznova

Pasteur Institute for Epidemiology and Microbiology

Email: fake@neicon.ru

PhD (Biology), Leading Researcher, Laboratory of Viral Hepatitis

Россия

M. A. Nаumova

Gabrichevsky Research Institute for Epidemiology and Microbiology

Email: fake@neicon.ru

PhD (Medicine), Senior Researcher, Laboratory of Immunochemistry

Россия

T. S. Chekhlyaeva

Gabrichevsky Research Institute for Epidemiology and Microbiology

Email: fake@neicon.ru

Junior Researcher, Laboratory of Immunochemistry

Россия

E. V. Vorobeychikovc

“Polypharm Ltd”

Email: fake@neicon.ru

PhD (Medicine), Senior Researcher

Россия

M. Ben Mamou

World Health Organization, Regional Office for Europe

Email: fake@neicon.ru
Measles/Rubella Laboratory Coordinator Дания

V. A. Aleshkin

Gabrichevsky Research Institute for Epidemiology and Microbiology

Email: fake@neicon.ru

Corresponding Member of the RANS, PhD, MD (Biology), Professor, Director

Россия

References

  1. Бобкова М.Р., Буравцова Е.В., Калашникова Т.В., Покровский В.В., Суворова З.К. Применение контрольных образцов для внутрилабораторного контроля качества скринингового ИФА на наличие антител к ВИЧ. М., 2004. [Bobkova M.R., Buravtsova E.V., Kalashnikova T.V., Pokrovskiy V.V., Suvorova Z.K. Primenenie kontrol’nykh obraztsov dlya vnutrilaboratornogo kontrolya kachestva skriningovogo IFA na nalichie antitel k VICh [The use of control samples for internal quality control screening ELISA for the presence of antibodies to HIV]. Moscow, 2004.]
  2. ГОСТ Р ИСО 5725-5-2002. Точность (правильность и прецизионность) методов и результатов измерений. Часть 1. М.: Гос стан дарт России, 2002. С. 2–3. [GOST R ISO 5725-5-2002. Tochnost’ (pravil’nost’ i pretsizionnost’) metodov i rezul’tatov izmerenii. Chast’ 1 [Accuracy (correctness and precision) of measurement methods and results. Part 1]. Moscow: Russian State Standard, 2002, pp. 2–3.]
  3. ГОСТ Р ИСО 15189-2006. Лаборатории медицинские. Частные требования к качеству и компетентности. М.: Стандартинформ, 2007. 34 c. [GOST R ISO 15189-2006. Laboratorii meditsinskie. Chastnye trebovaniya k kachestvu i kompetentnosti [Medical laboratories. Particular requirements for quality and competence]. Moscow: Standartinform, 2007. 34 p.]
  4. Мамаева Т.А., Тихонова Н.Т., Наумова М.А., Шульга С.В. Национальная лабораторная сеть Российской Федерации по диагностике кори и ее роль в выполнении программы ВОЗ по ликвидации кори // Здоровье населения и среда обитания. 2007. № 11 (176). С. 4–7. [Mamaevа T.A., Tikhonova N.T., Naumova M.A., Shulga S.V. National laboratory network of the Russian Federation for the diagnosis of measles and its role in the implementation of the program to eliminate measles WHO. Zdorov’e naseleniya i sreda obitaniya = Human Health and the Environment Inhabitation, 2007, no. 11 (176), pp. 4–7. (In Russ.)]
  5. Мамаева Т.А., Железнова Н.В., Наумова М.А., Говорухина М.В., Калашникова Н.А., Бичурина М.А., Мукомолов С.Л. Алгоритм лабораторного подтверждения и дифференциальной диагностики коревой инфекции в период элиминации кори в Российской Федерации // Инфекция и иммунитет. 2015. Т. 5, № 1. C.55–62. [Mamaeva T.A., Zheleznova N.V., Naumova M.A., Govoruhina M.V., Kalashnikova N.A., Bichurina M.A., Mukomolov S.L. Algorithm of laboratory confirmation and differential diagnosis of measles infection at the stage of the measles elimination program in Russia. Infektsiya i immunitet = Russian Journal of Infection and Immunity, 2015, vol. 5, no. 1, pp. 55–62. doi: 10.15789/2220-7619-2015-1-55-62 (In Russ.)]
  6. Мамаева Т.А., Наумова М.А., Железнова Н.В., Тураева Н.В., Баранов Н.И., Говорухина М.В., Владимирова Н.П., Липская Г.Ю. Итоги работы лабораторной сети по реализации программы ликвидации кори в РФ в 2003–2013 гг. // Здоровье населения и среда обитания. 2015. № 3. C. 51–54 [Mamaeva T.A., Naumova M.A., Zheleznova N.V., Turaeva N.V., Baranov N.I., Govoruhina M.V., Vladimirova N.P., Lipskaya G.Y. Results activities of the laboratory network on measles eradication program in the Russian Federation 2003–2013. Zdorov’e naseleniya i sreda obitaniya = Human Health and the Environment Inhabitation, 2015, no. 3, pp. 51–54. (In Russ.)]
  7. Медик В.А., Токмачев М.С., Фишман Б.Б. Статистика в медицине и биологии. Теоретическая статистика: в 2 т. Под ред. Ю.М. Комарова. М.: Медицина, 2000. Т. 1. 412 c. [Medik V.F., Njkmachev M.S., Fishman B.B. Statistika v meditsine i biologii. Teoreticheskaya statistika [Statistics in medicine and biology. Theoretical statistics: in 2 vol.]. Ed. Y.M. Komarov. Moscow: Meditsina, 2000. Vol. 1. 412 p.]
  8. Нетесова Е.Г., Ярославцева О.А., Цой Л.В., Жуков В.А., Нетесов С.В. Результаты участия 360 лабораторий России в Программе внешней оценки качества исследований НВsAg // Клиническая лабораторная диагностика. 2007. № 3. C. 47–50. [Netesova I.G., Yaroslavtseva O.A., Tsoy L.V., Zhukov V.A., Netesov S.V. Results of the participation of 360 laboratories of Russia in the external quality assessment program for HBsAg tests. Klinicheskaya laboratornaya diagnostika = Clinical Laboratory Diagnostics, 2007, no. 3, pp. 47–50. (In Russ.)]
  9. О системе мер по повышению качества клинических лабораторных исследований в учреждениях здравоохранения Российской Федерации: Приказ Минздрава России от 07.02.2000 № 45. [O sisteme mer po povysheniyu kachestva klinicheskikh laboratornykh issledovanii v uchrezhdeniyakh zdravookhraneniya Rossiiskoi Federatsii: Prikaz Minzdrava Rossii ot 07.02.2000 № 45 (On the system of measures to improve the quality of clinical laboratory tests in the Russian Federation health facilities: The Russian Ministry of Health Order from 07.02.2000 No 45)]
  10. Ризниченко Г.Ю. Лекции по математическим моделям в биологии. М.–Ижевск: Изд-во РХД, 2011. 560 с. [Riznichenko G.Y. Lektsii po matematicheskim modelyam v biologii [Lectures on mathematical models in biology]. Moscow–Izhevsk: Publishing House RHD, 2011. 560 p.]
  11. Система управления качеством в лабораториях. ВОЗ, 2013. 270 с. [Laboratory quality management system. WHO, 2013, 270 p.]
  12. Гланц С.А. Медико-биологическая статистика: пер. с англ. Под ред. Ю.А. Данилова. М.: Изд-во «Практика», 1999. 462 с. [Glantz S.A. Mediko-biologicheskaya statistika: per. s angl. Pod red. Yu.A. Danilova. [Biomedical statistics. Ed. Yu.A. Danilov]. Moscow: Publishing House “Practica”, 1999. 462 p.]
  13. Тихонова Н.Т., Мамаева Т.А., Шульга С.В., Ежлова Е.Б., Лыткина И.Н., Цвиркун О.В., Герасимова А.Г. Лабораторное обеспечение Программы ликвидации эндемичной кори в Российской Федерации // Эпидемиология и вакцино-профилактика. 2011. № 1. C. 36– 39. [Tikhonova N.T., Mamaeva T.A., Shul’ga S.V., Ezhlova E.B., Lytkina I.N., Tsvirkun O.V., Gerasimova A.G. Laboratory support of the Program elimination of endemic measles in the Russian Federation. Epidemiologiya i vaktsinoprofilaktika = Epidemiology and Vaccinal Prevention, 2011, no. 1, pp. 36–39. (In Russ.)]
  14. Arista S., Ferraro D., Cascio A., Vizzi E., Di Stefano R. Detection of IgM antibodies specific for measles virus by capture and indirect enzyme immunoassays. Res. Virol., 1995, vol. 3, no. 146, pp. 225–232.
  15. Вang H., Davidjan M. Experimental statistics for biological sciences. Methods Mol. Biol., 2010, no. 620, pp. 3–104. doi: 10.1007/978-1-60761-580-4_1
  16. Constantine N.T., Saville R.D., Dax E.M. Retroviral testing and quality assurance: essentials for laboratory diagnosis. MedMira Laboratories, Halifax, Canada.
  17. Dietz V., Rota J., Izurieta H., Carrasco P., Bellini W. The laboratory confirmation of suspected measles cases in setting of low 12 measles transmission: conclusions from the experience in the American 2004. Herald of the World Health Organization, 2004, vol. 82, no. 11, pp. 852–857.
  18. Fiebig E.W., Wright D.J., Rawal B.D., Garrett P.E., Schumacher R.T., Peddada L., Heldebrant C., Smith R., Conrad A., Kleinman S.H., Busch M.P. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS, 2003, no. 17, pp. 1871–1879.
  19. International Organization for Standardization. Medical laboratories: particular requirements for quality and competence. ISO 15189. International Organization for Standardization, Geneva, Switzerland, 2007.
  20. Kim J., Swantee C., Lee B., Gunning H., Chow A., Sidaway F., Sherlock C., Garceau R., Dimech W., Malloch L.; CAHCLS Laboratories. Identification of performance problems in a commercial human immunodeficiency virus type 1 ensyme immunoassay by multiuser external quality control monitoring and real-time data analysis. J. Clin. Microbiol., 2009, vol. 47, no. 10,pp. 3114–3120. doi: 10.1128/JCM.00892-09
  21. Perry K.R., Ramskill S., Eglin R.P., Barbara J.A.J., Parry J.V. Improvement in the performance of HIV screening kits. Transfus. Med., 2008, no. 18, pp. 228–240.
  22. Ratnam S., Tipples G., Head C., Fauvel M., Fearon M., Ward B.J. Perfomance of indirect immunoglobulin M (IgM) serology test and IgM capture assays for laboratory diagnosis of measles. J. Clin. Microbiol., 2000, no. 38, pp. 99–104.
  23. Westgard J.O., Barry P.L. Basic QC practices: training in statistical quality control for healthcare laboratories; 2nd ed. Westgard QC, Inc., Madison, WI 2002. 26 p.
  24. WHO. Manual for the laboratory diagnosis of measles and rubella virus infection; 2nd ed. Geneva. Switzerland: WHO, 2006, pp. 58–65.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2017 Mamaeva T.A., Zheleznova N.V., Nаumova M.A., Chekhlyaeva T.S., Vorobeychikovc E.V., Ben Mamou M., Aleshkin V.A.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 64788 от 02.02.2016.


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies