Hide
Show all
Email this article 
Post a Comment 
Dried tube specimens: A tool to ensure effective proficiency testing & quality control of Hepatitis B virus diagnosis in developing countries
Abstract
Background: Proficiency testing (PT) is a key component of Quality assurance to evaluate the laboratory performance. Although HBV testing has rapidly expanded worldwide, but in resource limited settings (RLS) like India there is still a lacunae in PT programs to monitor and improve the quality of testing. Conventional PT programs use serum or plasma specimens that require strict settings for storage and transportation. Thus the aim was to standardize dried tube specimens (DTS) technique for stability studies of HBV specimens as has been done for PT programs in HIV-EQAS.
Methods: Dried tube specimens, an unusual, simple and easy to use technique, were standardized that can help assessing the quality of Hepatitis B Surface Antigen (HBsAg) testing in RLS. DTS were prepared by drying 30µl of samples mixed with 0.1% of green dye, left overnight at room temperature. The DTS were rehydrated with 250µl of PBS–Tween buffer before testing. Twenty DTS samples (09 HBV positive and 11 negative) were used for performing ELISA and rapid tests at weekly interval for Dried tube specimens stored at 4ºC, 25ºC, 37ºC & 45ºC.
Results: Stability studies showed that HBsAg in the DTS specimens were stable upto 28 days at temperature 4°C, 25°C, 37°C & 45°C. We observed consistent and expected results for all the DTS samples by ELISA and rapid tests for the different durations and temperatures. No difference in the qualitative nature of the HBV reactive and non-reactive samples were observed for Dried tube specimens over 28 days duration and stored at 4ºC, 25ºC, 37°C & 45°C temperatures. However, a decline in HBsAg levels were observed after four weeks (28days) for a few specimens stored at 45ºC.
Conclusion: Stability results of this preliminary study indicate that the reactivity status was unchanged and maintained for HBV plasma samples upto 28 days at temperatures (4ºC, 25ºC 37°C& 45°C) in the dried tube specimens. Further we found DTS is an easy and simple method to prepare and transport quality control specimens for effective implementation of PT programs to monitor HBV testing in India.
Keywords
Full Text:
PDFReferences
. Barker LF, Shulman NR, Murray R, Hirschman RJ, Ratner F, Diefenbach WC, Geller HM. "Transmission of serum hepatitis. 1970". Journal of the American Medical Association. 1996; 276 (10): 841–844.
. Centers for Disease Control and Prevention, WHO, and Office of the United States Global AIDS Coordinator. 2005, posting date. Guidelines for assuring the accuracy and reliability of HIV rapid testing: applying a quality system approach. http://www.who.int/diagnostics_laboratory /publications/HIVRapidsGuide.pdf.
. Peeling, R. W., P. G. Smith, and M. M. Bossuyt. A guide for diagnostic evaluations. Nat. Rev. Microbiol. 2006; 4:S2–S6.
. Chang, D., K. Learmonth, and E. M. Dax. HIV testing in 2006: issues and methods. Expert Rev. Anti-Infect. Ther. 2006; 4:565–582.
. Martin, R., T. L. Hearn, J. C. Ridderhof, and A. Demby. Implementation of a quality systems approach for laboratory practice in resource constrained countries. AIDS 19 (Suppl. 2) 2005: S59–S65.
. Perkins, M. D., and P. M. Small. 2006. Partnering for better microbial diagnostics. Nat. Biotechnol. 24:919–921.
. Chalker, V. J., H. Vaughan, P. Patel, A. Rossouw, H. Seyedzadeh, K. Gerrard, and V. L. James. External quality assessment for detection of Chlamydia trachomatis. J. Clin. Microbiol. 2005; 43:1341–1347.
. Dax, E. M., and R. O’Connell. Standardisation of subjectively scored HIV immunoassays: developing a quality assurance program to assist in reproducible interpretation of results using an anti-HIV particle agglutination assay as a model. J. Virol. Methods 1999; 82:113–118.
. Learmonth K.M, McPhee D. A, Jardine D.K, Walker S.K, Aye T, Dax E.M. Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing. J Clin Microbiol, May 2008: 1692–1697.
. Gust, A., S. Walker, R. J. Chappel, and E. M. Dax. Anti-HIV quality assurance programs in Australian and the Southeast Asian and Western Pacific regions. Accred. Qual. Assur. 2001; 6:168–172.
. Kettelhut, M. M., P. L. Chiodini, H. Edwards, and A. Moody. 2003. External quality assessment schemes raise standards: evidence from the UKNEQAS parasitology subschemes. J. Clin. Pathol. 2006; 56:927–932.
. Parekh. B.S, Juliana A, Patel H, Downera M, Kaloua M, Gichimub C, et al. Dried tube specimens: A simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings. J. Virol. Methods 2010:163, 295–300.
DOI: http://dx.doi.org/10.7439/ijbar.v8i6.4194
Article Metrics
Metrics powered by PLOS ALM
Refbacks
- There are currently no refbacks.
Copyright (c) 2017 International Journal of Biomedical and Advance Research
This work is licensed under a Creative Commons Attribution 4.0 International License.