메뉴 건너뛰기




Volumn 23, Issue 3, 2010, Pages 550-576

Validation of laboratory-developed molecular assays for infectious diseases

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; CROSS REACTION; DATA ANALYSIS; FOOD AND DRUG ADMINISTRATION; INFECTION; LABORATORY TEST; LINEAR REGRESSION ANALYSIS; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; SENSITIVITY ANALYSIS; VALIDATION PROCESS; COMMUNICABLE DISEASES; DIAGNOSTIC PROCEDURE; HUMAN; MOLECULAR DIAGNOSIS; PROCEDURES; STANDARDS; VALIDATION STUDY;

EID: 77954605045     PISSN: 08938512     EISSN: 10986618     Source Type: Journal    
DOI: 10.1128/CMR.00074-09     Document Type: Review
Times cited : (389)

References (82)
  • 1
    • 56749106410 scopus 로고    scopus 로고
    • Real-time PCR system targeting a chromosomal marker specific for Bacillus anthracis
    • Antwerpen, M. H., P. Zimmermann, K. Bewley, D. Frangoulidis, and H. Meyer. 2008. Real-time PCR system targeting a chromosomal marker specific for Bacillus anthracis. Mol. Cell Probes 22:313-315.
    • (2008) Mol. Cell Probes , vol.22 , pp. 313-315
    • Antwerpen, M.H.1    Zimmermann, P.2    Bewley, K.3    Frangoulidis, D.4    Meyer, H.5
  • 2
    • 0029992713 scopus 로고    scopus 로고
    • The use of mimics as internal standards to avoid false negatives in diagnostic PCR
    • Ballagi-Pordany, A., and S. Belak. 1996. The use of mimics as internal standards to avoid false negatives in diagnostic PCR. Mol. Cell Probes 10:159-164.
    • (1996) Mol. Cell Probes , vol.10 , pp. 159-164
    • Ballagi-Pordany, A.1    Belak, S.2
  • 3
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet i:307-310.
    • (1986) Lancet , vol.1 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 4
    • 66349108821 scopus 로고    scopus 로고
    • Validation of the TaqMan Influenza A Detection Kit and a rapid automated total nucleic acid extraction method to detect influenza a virus in nasopharyngeal specimens
    • Bolotin, S., C. De Lima, K. W. Choi, E. Lombos, L. Burton, T. Mazzulli, and S. J. Drews. 2009. Validation of the TaqMan Influenza A Detection Kit and a rapid automated total nucleic acid extraction method to detect influenza A virus in nasopharyngeal specimens. Ann. Clin. Lab. Sci. 39:155-159.
    • (2009) Ann. Clin. Lab. Sci. , vol.39 , pp. 155-159
    • Bolotin, S.1    De Lima, C.2    Choi, K.W.3    Lombos, E.4    Burton, L.5    Mazzulli, T.6    Drews, S.J.7
  • 5
    • 40849114318 scopus 로고    scopus 로고
    • Development and evaluation of real-time loop-mediated isothermal amplification for hepatitis B virus DNA quantification: A new tool for HBV management
    • Cai, T., G. Lou, J. Yang, D. Xu, and Z. Meng. 2008. Development and evaluation of real-time loop-mediated isothermal amplification for hepatitis B virus DNA quantification: a new tool for HBV management. J. Clin. Virol. 41:270-276.
    • (2008) J. Clin. Virol. , vol.41 , pp. 270-276
    • Cai, T.1    Lou, G.2    Yang, J.3    Xu, D.4    Meng, Z.5
  • 10
    • 33750447404 scopus 로고    scopus 로고
    • CLSI/NCCLS. CLSI document EP7-A2. Clinical and Laboratory Standards Institute, Wayne, PA
    • CLSI/NCCLS. 2005. Interference testing in clinical chemistry. Approved guideline. CLSI document EP7-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
    • (2005) Interference Testing in Clinical Chemistry. Approved Guideline
  • 13
    • 77954581774 scopus 로고    scopus 로고
    • CLSI/NCCLS. 2nd ed. CLSI document EP14-A2. Clinical and Laboratory Standards Institute, Wayne, PA
    • CLSI/NCCLS. 2005. Evaluation of matrix effects. Approved guideline, 2nd ed. CLSI document EP14-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
    • (2005) Evaluation of Matrix Effects. Approved Guideline
  • 20
    • 77954597957 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 56. Institutional review boards
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 56. Institutional review boards. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 21
    • 77954572340 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 807. Establishment registration and device listing for manufacturers and initial importers of devices
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 807. Establishment registration and device listing for manufacturers and initial importers of devices. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 22
    • 77954615471 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. in vitro diagnostic products for human use, section 809.10. Labeling for in vitro diagnostic products
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. In vitro diagnostic products for human use, section 809.10. Labeling for in vitro diagnostic products. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 23
    • 77954615471 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. in vitro diagnostic products for human use, section 809.20. General requirements for manufacturers and producers of in vitro diagnostic products
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. In vitro diagnostic products for human use, section 809.20. General requirements for manufacturers and producers of in vitro diagnostic products. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 24
    • 77954615471 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. in vitro diagnostic products for human use, section 809.30. Restrictions on the sale, distribution and use of analyte specific reagents
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 809. In vitro diagnostic products for human use, section 809.30. Restrictions on the sale, distribution and use of analyte specific reagents. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 25
    • 77954584298 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 812. Investigational device exemptions
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 812. Investigational device exemptions. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 26
    • 77954570666 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 820. Quality system regulation
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 820. Quality system regulation. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 27
    • 77954597956 scopus 로고    scopus 로고
    • Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 864. Hematology and pathology devices, section 864.4020. Analyte specific reagents
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2010. Title 21. Food and drugs, vol. 8, chapter 1. Food and Drug Administration, Department of Health and Human Services, part 864. Hematology and pathology devices, section 864.4020. Analyte specific reagents. U.S. Government Printing Office, Washington, DC.
    • (2010) Code of Federal Regulations
  • 28
    • 77954604632 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.2. Definitions
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.2. Definitions. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 29
    • 77954596334 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1253. Standard: Establishment and verification of performance specifications
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1253. Standard: establishment and verification of performance specifications. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 30
    • 77954596334 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1255. Standard: Calibration and calibration verification procedures
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1255. Standard: calibration and calibration verification procedures. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 31
    • 77954596334 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1256. Standard: Control Procedures
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1256. Standard: control Procedures. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 32
    • 77954580930 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1282. Standard: Corrective actions
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1282. Standard: corrective actions. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 33
    • 77954596334 scopus 로고    scopus 로고
    • Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1455. Standard: Clinical consultant qualifications
    • U.S. Government Printing Office, Washington, DC
    • Code of Federal Regulations. 2009. Title 42. Public health, vol. 4, chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory requirements, section 493.1455. Standard: clinical consultant qualifications. U.S. Government Printing Office, Washington, DC.
    • (2009) Code of Federal Regulations
  • 34
    • 77951988431 scopus 로고    scopus 로고
    • College of American Pathologists, Commission on Laboratory Accreditation. College of American Pathologists, North-field, IL
    • College of American Pathologists, Commission on Laboratory Accreditation. 2009. Microbiology checklist. College of American Pathologists, North-field, IL.
    • (2009) Microbiology Checklist
  • 35
    • 77954592308 scopus 로고    scopus 로고
    • College of American Pathologists, Commission on Laboratory Accreditation. College of American Pathologists, Northfield, IL
    • College of American Pathologists, Commission on Laboratory Accreditation. 2009. Molecular pathology checklist. College of American Pathologists, Northfield, IL.
    • (2009) Molecular Pathology Checklist
  • 36
    • 24744438458 scopus 로고    scopus 로고
    • Use of bacteriophage MS2 as an internal control in viral reverse transcription-PCR assays
    • Dreier, J., M. Störmer, and K. Kleesiek. 2005. Use of bacteriophage MS2 as an internal control in viral reverse transcription-PCR assays. J. Clin. Microbiol. 43:4551-4557.
    • (2005) J. Clin. Microbiol. , vol.43 , pp. 4551-4557
    • Dreier, J.1    Störmer, M.2    Kleesiek, K.3
  • 37
    • 33747174782 scopus 로고    scopus 로고
    • Enhanced reverse transcription-PCR assay for detection of norovirus genogroup I
    • Dreier, J., M. Störmer, D. Mäde, S. Burkhardt, and K. Kleesiek. 2006. Enhanced reverse transcription-PCR assay for detection of norovirus genogroup I. J. Clin. Microbiol. 44:2714-2720.
    • (2006) J. Clin. Microbiol. , vol.44 , pp. 2714-2720
    • Dreier, J.1    Störmer, M.2    Mäde, D.3    Burkhardt, S.4    Kleesiek, K.5
  • 38
    • 0034747327 scopus 로고    scopus 로고
    • TaqMan 5′-nuclease human immunodeficiency virus type 1 PCR assay with phage-packaged competitive internal control for high-throughput blood donor screening
    • Drosten, C., E. Seifried, and W. K. Roth. 2001. TaqMan 5′-nuclease human immunodeficiency virus type 1 PCR assay with phage-packaged competitive internal control for high-throughput blood donor screening. J. Clin. Microbiol. 39:4302-4308.
    • (2001) J. Clin. Microbiol. , vol.39 , pp. 4302-4308
    • Drosten, C.1    Seifried, E.2    Roth, W.K.3
  • 42
    • 84925564615 scopus 로고    scopus 로고
    • Section 201(h), now codified as Title 21, food and drugs, chapter 9, Federal Food, Drug, and Cosmetic Act, subchapter II definitions, section 321(h), U.S. Code
    • U.S. House of Representatives, Washington, DC
    • Federal Food, Drug and Cosmetic Act. Section 201(h), now codified as Title 21, food and drugs, chapter 9, Federal Food, Drug, and Cosmetic Act, subchapter II definitions, section 321(h), U.S. Code. U.S. House of Representatives, Washington, DC.
    • Federal Food, Drug and Cosmetic Act
  • 43
    • 77954583996 scopus 로고    scopus 로고
    • Viral infections in transplant patients
    • D. G. B. Leonard (ed.), Springer Science+Business Media, LLC, New York, N
    • Ferreira-Gonzalez, A., and A. M. Caliendo. 2007. Viral infections in transplant patients. In D. G. B. Leonard (ed.), Molecular pathology in clinical practice, Springer Science+Business Media, LLC, New York, N.
    • (2007) Molecular Pathology in Clinical Practice
    • Ferreira-Gonzalez, A.1    Caliendo, A.M.2
  • 44
    • 0038296381 scopus 로고    scopus 로고
    • Food and Drug Administration. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, Rockville, MD
    • Food and Drug Administration. 2001. FDA guidance for industry: bioanalytical method validation. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, Rockville, MD.
    • (2001) FDA Guidance for Industry: Bioanalytical Method Validation
  • 45
    • 17644381565 scopus 로고    scopus 로고
    • Real-time PCR quantitation of hepatitis B virus DNA using automated sample preparation and murine cytomegalovirus internal control
    • Garson, J. A., P. R. Grant, U. Ayliffe, R. B. Ferns, and R. S. Tedder. 2005. Real-time PCR quantitation of hepatitis B virus DNA using automated sample preparation and murine cytomegalovirus internal control. J. Virol. Methods 126:207-213.
    • (2005) J. Virol. Methods , vol.126 , pp. 207-213
    • Garson, J.A.1    Grant, P.R.2    Ayliffe, U.3    Ferns, R.B.4    Tedder, R.S.5
  • 46
    • 0004312557 scopus 로고    scopus 로고
    • International Organization for Standardization. ISO 3534-1. International Organization for Standardization, Geneva, Switzerland
    • International Organization for Standardization. 2006. Statistics - vocabulary and symbols, part 1. Probability and general statistical terms. ISO 3534-1. International Organization for Standardization, Geneva, Switzerland.
    • (2006) Statistics - Vocabulary and Symbols, Part 1. Probability and General Statistical Terms
  • 47
    • 0004021751 scopus 로고
    • International Organization for Standardization. International Organization for Standardization, Geneva, Switzerland
    • International Organization for Standardization. 1993. International vocabulary of basic and general terms in metrology. International Organization for Standardization, Geneva, Switzerland.
    • (1993) International Vocabulary of Basic and General Terms in Metrology
  • 48
    • 0842343571 scopus 로고    scopus 로고
    • International Organization for Standardization. ISO 15189, 2nd ed. International Organization for Standardization, Geneva, Switzerland
    • International Organization for Standardization. 2007. Medical laboratories - particular requirements for quality and competence. ISO 15189, 2nd ed. International Organization for Standardization, Geneva, Switzerland.
    • (2007) Medical Laboratories - Particular Requirements for Quality and Competence
  • 50
    • 65649113589 scopus 로고    scopus 로고
    • Recommended principles and practices for validating clinical molecular pathology tests
    • Jennings, L., V. M. Van Deerlin, and M. L. Gulley. 2009. Recommended principles and practices for validating clinical molecular pathology tests. Arch. Pathol. Lab. Med. 133:743-755.
    • (2009) Arch. Pathol. Lab. Med. , vol.133 , pp. 743-755
    • Jennings, L.1    Van Deerlin, V.M.2    Gulley, M.L.3
  • 51
    • 69749092365 scopus 로고    scopus 로고
    • Assessment of bias with emphasis on medical comparison
    • Johnson, R. 2008. Assessment of bias with emphasis on medical comparison. Clin. Biochem. Rev. 29:S37-S42.
    • (2008) Clin. Biochem. Rev. , vol.29
    • Johnson, R.1
  • 52
    • 32044463133 scopus 로고    scopus 로고
    • Highly sensitive real-time PCR for specific detection and quantification of Coxiella burnetii
    • Klee, S. R., J. Tyczka, H. Ellerbrok, T. Franz, S. Linke, G. Baljer, and B. Appel. 2006. Highly sensitive real-time PCR for specific detection and quantification of Coxiella burnetii. BMC Microbiol. 6:2.
    • (2006) BMC Microbiol. , vol.6 , pp. 2
    • Klee, S.R.1    Tyczka, J.2    Ellerbrok, H.3    Franz, T.4    Linke, S.5    Baljer, G.6    Appel, B.7
  • 53
    • 0003161762 scopus 로고    scopus 로고
    • Selection and evaluation of methods
    • C. A. Burtis and E. R. Ashwood (ed.), 3rd ed. W. B. Saunders Co., Philadelphia, PA
    • Koch, D. D., and T. Peters. 1999. Selection and evaluation of methods In C. A. Burtis and E. R. Ashwood (ed.), Tietz textbook of clinical chemistry, 3rd ed. W. B. Saunders Co., Philadelphia, PA.
    • (1999) Tietz Textbook of Clinical Chemistry
    • Koch, D.D.1    Peters, T.2
  • 54
    • 53049109171 scopus 로고    scopus 로고
    • Detection and differentiation of human papillomavirus genotypes HPV-6 and HPV-11 by FRET-based real-time PCR
    • Kocjan, B. J., K. Seme, and M. Poljak. 2008. Detection and differentiation of human papillomavirus genotypes HPV-6 and HPV-11 by FRET-based real-time PCR. J. Virol. Methods 153:245-249.
    • (2008) J. Virol. Methods , vol.153 , pp. 245-249
    • Kocjan, B.J.1    Seme, K.2    Poljak, M.3
  • 56
    • 0032999776 scopus 로고    scopus 로고
    • Necessary sample size for method comparison studies based on regression analysis
    • Linnet, K. 1999. Necessary sample size for method comparison studies based on regression analysis. Clin. Chem. 45:882-894.
    • (1999) Clin. Chem. , vol.45 , pp. 882-894
    • Linnet, K.1
  • 57
    • 33645725385 scopus 로고    scopus 로고
    • Selection and analytical evaluation of methods - With statistical techniques
    • C. A. Burtis, E. R. Ashwood, and D. E. Bruns (ed.), 4th ed. Elsevier Saunders, Philadelphia, PA
    • Linnet, K., and J. C. Boyd. 2006. Selection and analytical evaluation of methods - with statistical techniques. In C. A. Burtis, E. R. Ashwood, and D. E. Bruns (ed.), Tietz textbook of clinical chemistry, 4th ed. Elsevier Saunders, Philadelphia, PA.
    • (2006) Tietz Textbook of Clinical Chemistry
    • Linnet, K.1    Boyd, J.C.2
  • 58
  • 59
    • 12844282923 scopus 로고    scopus 로고
    • Performance and cost evaluation of one commercial and six in-house conventional and real-time reverse transcription-PCR assays for detection of severe acute respiratory syndrome coronavirus
    • Mahony, J. B., A. Petrich, L. Louie, X. Song, S. Chong, M. Smieja, M. Chernesky, M. Loeb, and S. Richardson. 2004. Performance and cost evaluation of one commercial and six in-house conventional and real-time reverse transcription-PCR assays for detection of severe acute respiratory syndrome coronavirus. J. Clin. Microbiol. 42:1471-1476.
    • (2004) J. Clin. Microbiol. , vol.42 , pp. 1471-1476
    • Mahony, J.B.1    Petrich, A.2    Louie, L.3    Song, X.4    Chong, S.5    Smieja, M.6    Chernesky, M.7    Loeb, M.8    Richardson, S.9
  • 60
    • 34247158176 scopus 로고    scopus 로고
    • A novel internally controlled real-time reverse transcription-PCR assay for HIV-1 RNA targeting the pol integrase genomic region
    • Müller, J., A. M. Eis-Hübinger, M. Däumer, R. Kaiser, J. M. Rox, L. Gürtler, L. P. Hanfland, and B. Pötzsch. 2007. A novel internally controlled real-time reverse transcription-PCR assay for HIV-1 RNA targeting the pol integrase genomic region. J. Virol. Methods 142:127-135.
    • (2007) J. Virol. Methods , vol.142 , pp. 127-135
    • Müller, J.1    Eis-Hübinger, A.M.2    Däumer, M.3    Kaiser, R.4    Rox, J.M.5    Gürtler, L.6    Hanfland, L.P.7    Pötzsch, B.8
  • 64
    • 0031024931 scopus 로고    scopus 로고
    • "Sensitivity" and "specificity" reconsidered: The meaning of these terms in analytical and diagnostic settings
    • Saah, A. J., and D. R. Hoover. 1997. "Sensitivity" and "specificity" reconsidered: the meaning of these terms in analytical and diagnostic settings. Ann. Intern. Med. 126:91-94.
    • (1997) Ann. Intern. Med. , vol.126 , pp. 91-94
    • Saah, A.J.1    Hoover, D.R.2
  • 65
    • 0027829642 scopus 로고
    • Assays for viral sequences and their value in validation of viral elimination
    • Saldanha, J. 1993. Assays for viral sequences and their value in validation of viral elimination. Dev. Biol. Stand. 81:231-236.
    • (1993) Dev. Biol. Stand. , vol.81 , pp. 231-236
    • Saldanha, J.1
  • 66
    • 34249937313 scopus 로고    scopus 로고
    • Real-time PCR in clinical microbiology: Verification, validation, and contamination control
    • Sloan, L. M. 2007. Real-time PCR in clinical microbiology: verification, validation, and contamination control. Clin. Microbiol. Newsl. 29:87-95.
    • (2007) Clin. Microbiol. Newsl. , vol.29 , pp. 87-95
    • Sloan, L.M.1
  • 67
    • 84925571790 scopus 로고    scopus 로고
    • Section 1862(a) (1), exclusions from coverage and Medicare as a second payer, now codified as Title 42, chapter 7, exclusions from coverage and Medicare as a second payer, U.S. Code
    • U.S. House of Representatives, Washington, DC
    • Social Security Act. Section 1862(a) (1), exclusions from coverage and Medicare as a second payer, now codified as Title 42, chapter 7, exclusions from coverage and Medicare as a second payer, U.S. Code. U.S. House of Representatives, Washington, DC.
    • Social Security Act.
  • 68
    • 33846017338 scopus 로고    scopus 로고
    • High-volume extraction of nucleic acids by magnetic bead technology for ultrasensitive detection of bacteria in blood components
    • Störmer, M., K. Kleesiek, and J. Dreier. 2007. High-volume extraction of nucleic acids by magnetic bead technology for ultrasensitive detection of bacteria in blood components. Clin. Chem. 53:104-110.
    • (2007) Clin. Chem. , vol.53 , pp. 104-110
    • Störmer, M.1    Kleesiek, K.2    Dreier, J.3
  • 70
    • 0036310862 scopus 로고    scopus 로고
    • Harmonized guidelines for single-laboratory validation of methods of analysis
    • Thompson, R., S. L. R. Ellison, and R. Wood. 2002. Harmonized guidelines for single-laboratory validation of methods of analysis. Pure Appl. Chem. 74:835-855.
    • (2002) Pure Appl. Chem. , vol.74 , pp. 835-855
    • Thompson, R.1    Ellison, S.L.R.2    Wood, R.3
  • 71
    • 84925571789 scopus 로고    scopus 로고
    • Reference deleted
    • Reference deleted.
  • 72
    • 0027128154 scopus 로고
    • Clinical laboratory improvement amendments of 1988 (CLIA)
    • U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services
    • U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. 1992. Clinical laboratory improvement amendments of 1988 (CLIA). Fed. Regist. 57:7002-7186.
    • (1992) Fed. Regist. , vol.57 , pp. 7002-7186
  • 73
    • 0037462668 scopus 로고    scopus 로고
    • Medicare, Medicaid and CLIA programs: Laboratory requirements relating to quality systems and certain personnel qualifications. Final rule
    • U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services.
    • U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. 2003. Medicare, Medicaid and CLIA programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final rule. Fed. Regist. 16:3640-3714.
    • (2003) Fed. Regist. , vol.16 , pp. 3640-3714
  • 74
    • 0025164789 scopus 로고
    • Evaluating diagnostic tests with imperfect standards
    • Valenstein, P. N. 1990. Evaluating diagnostic tests with imperfect standards. Am. J. Clin. Pathol. 93:252-258.
    • (1990) Am. J. Clin. Pathol. , vol.93 , pp. 252-258
    • Valenstein, P.N.1
  • 75
    • 34447101747 scopus 로고    scopus 로고
    • Performance testing of two new one-step real time PCR assays for detection of human influenza and avian influenza viruses isolated in humans and respiratory syncytial virus
    • Valle, L., D. Amicizia, S. Bacilieri, F. Banfi, R. Riente, P. Durando, L. Sticchi, R. Gasparini, C. Esposito, G. Icardi, and F. Ansaldi. 2006. Performance testing of two new one-step real time PCR assays for detection of human influenza and avian influenza viruses isolated in humans and respiratory syncytial virus. J. Prev. Med. Hyg. 47:127-133.
    • (2006) J. Prev. Med. Hyg. , vol.47 , pp. 127-133
    • Valle, L.1    Amicizia, D.2    Bacilieri, S.3    Banfi, F.4    Riente, R.5    Durando, P.6    Sticchi, L.7    Gasparini, R.8    Esposito, C.9    Icardi, G.10    Ansaldi, F.11
  • 77
    • 0142074551 scopus 로고    scopus 로고
    • 2nd ed. Westgard QC, Inc., Madison, WI
    • Westgard, J. O. 2002. Basic QC practices, 2nd ed. Westgard QC, Inc., Madison, WI.
    • (2002) Basic QC Practices
    • Westgard, J.O.1
  • 80
    • 77954578986 scopus 로고
    • World Health Organization Expert Committee on Biological Standardization. WHO unpublished document BS/95.1793. World Health Organization, Geneva, Switzerland
    • World Health Organization Expert Committee on Biological Standardization. 1995. Glossary of terms for biological substances used for texts of the requirements. WHO unpublished document BS/95.1793. World Health Organization, Geneva, Switzerland.
    • (1995) Glossary of Terms for Biological Substances Used for Texts of the Requirements
  • 81
    • 24144490009 scopus 로고    scopus 로고
    • Optimized real-time quantitative PCR measurement of male fetal DNA in maternal plasma
    • Zimmermann, B., A. El-Sheikhah, K. Nicolaides, W. Holzgreve, and S. Hahn. 2005. Optimized real-time quantitative PCR measurement of male fetal DNA in maternal plasma. Clin. Chem. 51:1598-1604.
    • (2005) Clin. Chem. , vol.51 , pp. 1598-1604
    • Zimmermann, B.1    El-Sheikhah, A.2    Nicolaides, K.3    Holzgreve, W.4    Hahn, S.5
  • 82
    • 27744552786 scopus 로고    scopus 로고
    • Real-time PCR assay for the detection of tanapox virus and yaba-like disease virus
    • Zimmermann, P., I. Thordsen, D. Frangoulidis, and H. Meyer. 2005. Real-time PCR assay for the detection of tanapox virus and yaba-like disease virus. J. Virol. Methods 130:149-153.
    • (2005) J. Virol. Methods , vol.130 , pp. 149-153
    • Zimmermann, P.1    Thordsen, I.2    Frangoulidis, D.3    Meyer, H.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.