References

1. Medicare, Medicaid and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Fed. Regi. 1992.

2. College of American Pathologists Laboratory Accreditation Program. Internet website http://www.cap.org.

3. National Committee for Clinical Laboratory Standards. Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline. NCCLS document MM1-A. NCCLS, Wayne, PA, 2000.

4. National Committee for Clinical Laboratory Standards. Immunoglobulin and T-cell Receptor Gene Rearrangement Assays; Approved Guideline. NCCLS document MM2-A2. NCCLS, Wayne, PA, 2002.

5. National Committee for Clinical Laboratory Standards. Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline. NCCLS document MM3-A. NCCLS, Wayne, PA, 1995.

6. National Committee for Clinical Laboratory Standards. Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline. NCCLS document MM5-A. NCCLS, Wayne, PA, 2000.

7. National Committee for Clinical Laboratory Standards. Quantitative Molecular Methods for Infectious Diseases; Approved Guideline. NCCLS document MM6-A. NCCLS, Wayne, PA, 2001.

8. National Committee for Clinical Laboratory Standards. Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline. NCCLS document MM9-A. NCCLS, Wayne, PA, 2004.

9. National Committee for Clinical Laboratory Standards. Genotyping for Infectious Disease: Identification and Characterization; Proposed Guideline. NCCLS document MM10-P. NCCLS, Wayne, PA, 2005.

10. National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS document EP5-A. NCCLS, Wayne, PA, 1999.

11. National Committee for Clinical Laboratory Standards. Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline. NCCLS document EP6-A. NCCLS, Wayne, PA, 2001.

12. National Committee for Clinical Laboratory Standards. Interference Testing in Clinical Chemistry; Approved Guideline. NCCLS document EP7-A. NCCLS, Wayne, PA, 2003.

13. McCurdy, B.W. (ed.). Cumitech 31: Verification and Validation of Procedures in the Clinical Microbiology Laboratory. ASM, Herndon, VA, 1997.

14. Association for Molecular Pathology Statement.Recommendations for in-house development and operation of molecular diagnostic tests. Am. J. Clin. Pathol. 111:449-463, 1999.

15. Mansy, F., Brancart, F., Liesnard, C., Bollen, A., and Godfroid, E. A PCR based DNA hybridisation capture system for the detection of human cytomegalovirus. A comparative study with other identification methods. J. Virol. Methods 80:113-122, 1999.

16. Akane, A., Matsubara, K., Nakamura, H., Takahashi, S., and Kimura, K. Identification of the heme compound copurified with deoxyribonucleic acid (DNA) from bloodstains, a major inhibitor of polymerase chain reaction (PCR) amplification. Forensic Sci. 39:362-372, 1994.

17. Satsangi, J., Jewell, D.P., Welsh, K., Bunce, M., and Bell, J.I. Effect of heparin on polymerase chain reaction. Lancet 343:1509-1510, 1994.

18. Wang, J.T., Wan, T.H., Sheu, J.C., Lin, S.M., Lin, J.T., and Chen, D.S. Effects of anticoagulants and storage of blood samples on efficacy of the polymerase chain reaction assay for hepatitis C virus. J. Clin. Microbiol. 30:750-753, 1992.

19. Wiedbrauk, D.L., Werner, J.C., and Drevon, A.M. Inhibition of PCR by aqueous and vitreous fluids. J. Clin. Microbiol. 33:2643-2646, 1995.

20. Rossen, L., Noskov, P., Holmstrom, K., and Rasmussen, O.F. Inhibition of PCR by components of food samples, microbial diagnostic assays and DNA-extraction solution. Int. J. Food Microbiol. 17:37-45, 1992.

21. Khan, G., Kangro, H.O., Coates, P.J., and Heath, R.B. Inhibitory effects of urine on the polymerase chain reaction for cytomegalovirus DNA. J. Clin. Pathol. 44:360-365, 1991.

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