Advertisement
The Body: The Complete HIV/AIDS Resource Follow Us Follow Us on Facebook Follow Us on Twitter
Professionals >> Visit The Body PROThe Body en Espanol
Take Tell Us What YOU Think! Take The Body's Visitor Survey!
  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

1997 Revised Guidelines for Performing CD4+ T-Cell Determinations in Persons Infected with Human Immunodeficiency Virus (HIV)

References

January 10, 1997

1. Turner BJ, Hecht FM, Ismail RB. CD4+ T-lymphocyte measures in the treatment of individuals infected with human immunodeficiency virus type 1: a review for clinical practitioners. Arch Intern Med 1994;154(14):1561-73.

Advertisement
2. Fei DT, Paxton H, Chen AB. Difficulties in precise quantitation of CD4+ T-lymphocytes for clinical trials: a review. Biologicals 1993;21:221-31.

3. Hoover DR, Graham NM, Chen B, et al. Effect of CD4+ cell count measurement variability on staging HIV-1 infection. J Acquir Immune Defic Syndr 1992;5:794-802.

4. DeWolf F, Roos M, Lange JMA, et al. Decline in CD4+ cell numbers reflects increase in HIV-1 replication. AIDS Res Hum Retroviruses 1988;4:433-40.

5. Giorgi J, Nishanian P, Schmid I, Hultin L, Cheng H, Detels R. Selective alterations in immunoregulatory lymphocyte subsets in early HIV (human T-lymphotropic virus type III/lymphadenopathy-associated virus) infection. J Clin Immunol 1987;7:140-50.

6. Lang W, Perkins H, Anderson RE, Royce R, Jewell N, Winkelstein W Jr. Patterns of T-lymphocyte changes with human immunodeficiency virus infection: from seroconversion to the development of AIDS. J Acquir Immune Defic Syndr 1989;2:63-9.

7. Masur H, Ognibene FP, Yarchoan R, et al. CD4 counts as predictors of opportunistic pneumonias in human immunodeficiency virus (HIV) infection. Ann Intern Med 1989;111:223-31.

8. Smith RD. The pathobiology of HIV infection. Arch Pathol Lab Med 1990;114:235-9.

9. Hanson DL, Chu SY, Farizo KM, Ward JW. Distribution of CD4+ T-lymphocytes at diagnosis of acquired immunodeficiency syndrome-defining and other human immunodeficiency virus-related illnesses. The Adult and Adolescent Spectrum of HIV Disease Project Group. Arch Intern Med 1995;155:1537-42.

10. Stein DS, Korvick JA, Vermund SH. CD4+ lymphocyte cell enumeration for prediction of clinical course of human immunodeficiency virus disease: a review. J Infect Dis 1992;165:352-63.

11. CDC. Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR 1992;41(No. RR-4).

12. CDC. 1995 revised guidelines for prophylaxis against Pneumocytis carinii pneumonia for children infected with or perinatally exposed to human immunodeficiency virus. MMWR 1995; 44(No. RR-4):1-11.

13. National Institutes of Health. Recommendations for Zidovudine: early infection. JAMA 1990; 263(12):1606,1609.

14. Goldman AI, Carlin BP, Crane LR, et al. Response of CD4 lymphocytes and clinical consequences of treatment using ddI or ddC in patients with advanced HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol 1996;11:161-9.

15. Graham NMH, Piantadosi S, Park LP, Phair JP, Rinaldo CR, Fahey JL. CD4+ lymphocyte response to Zidovudine as a predictor of AIDS-free time and survival time. J Acquir Immune Defic Syndr 1993;6:1258-66.

16. De Gruttola V, Gelman R, Lagakos S. Uses of CD4-lymphocyte count in AIDS treatment decisions. Infect Agents Dis 1994;2:304-13.

17. Fahey JL, Taylor JMG, Detels R, et al. The prognostic value of cellular and serologic markers in infection with human immunodeficiency virus type 1. N Engl J Med 1990;322:166-72.

18. CDC. 1994 revised classification system for human immunodeficiency virus infection in children less than 13 years of age. Official authorized addenda: human immunodeficiency virus infection codes and official guidelines for coding and reporting ICD-9-CM. MMWR 1994;43(No. RR-12): 1-19.

19. CDC. USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus: a summary. MMWR 1995;44(No. RR-8):1-34.

20. CDC. Recommendations for counseling persons infected with human T-lymphotrophic virus, types I and II. Recommendations on prophylaxis and therapy for disseminated Mycobacterium avium complex for adults and adolescents infected with HIV. MMWR 1993;42(No. RR-9):17-20.

21. CDC. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992;41(No. RR-17):1-35.

22. Nicholson JKA, Landay AL. Use of flow Cytometry to enumerate lymphocyte populations in HIV disease. In: Schochetman G, George JR, eds. AIDS testing: a comprehensive guide to technical, medical, social, legal, and management issues. 2nd ed. New York, NY: Springer-Verlag, 1994:170-95.

23. Keren DF, ed. Flow Cytometry in clinical diagnosis. 1st ed. Chicago: American Society of Clinical Pathologists, 1989.

24. Hoffman RA, Kung PC, Hansen WP, Goldstein G. Simple and rapid measurement of human T-lymphocytes and their subclasses in peripheral blood. Proc Natl Acad Sci USA 1980;77: 4914-7.

25. Landay A, Ohlsson-Wilhelm B, Giorgi JV. Application of flow Cytometry to the study of HIV infection. AIDS 1990;4:479-97.

26. Loken MR, Stall AM. Flow Cytometry as an analytical and preparative tool in immunology. J Immunol Methods 1982;50:R85-112.

27. Lovett EJ, Schnitzer B, Keren DF, Flint A, Hudson JL, McClatchey KD. Application of flow Cytometry to diagnostic pathology. Lab Invest 1984;50:115-40.

28. Parks DR, Herzenberg LA. Fluorescence-activated cell sorting: theory, experimental optimization, and applications in lymphoid cell biology. Methods Enzymol 1984;108:197-241.

29. National Committee for Clinical Laboratory Standards. Clinical applications of flow Cytometry . Quality assurance and immunophenotyping of peripheral blood lymphocytes. Wayne, PA: National Committee for Clinical Laboratory Standards, 1992. NCCLS document no. H42-T.

30. Association of State and Territorial Public Health Laboratory Directors. Report and recommendations: flow Cytometry -- Sixth Annual Conference on Human Retrovirus Testing. Kansas City, MO: 1991;17-9.

31. Calvelli T, Denny TN, Paxton H, Gelman R, Kagan J. Guidelines for flow cytometric immunophenotyping: a report from the National Institutes of Allergy and Infectious Diseases, Division of AIDS. Cytometry 1993;14:702-15.

32. Nicholson J, Kidd P, Mandy F, Livnat D, Kagan J. Three-color supplement to the NIAID DAIDS guideline for flow cytometric immunophenotyping. Cytometry 1996;26:227-30.

33. CDC. Guidelines for the performance of CD4+ T-cell determinations in persons with human immunodeficiency virus infection. MMWR 1992;41(No. RR-8):1-17.

34. CDC. 1994 Revised guidelines for the performance of CD4+ T-cell determinations in persons with human immunodeficiency virus (HIV) infection. MMWR 1994;43(No. RR-3):1-21.

35. McCoy JP Jr, Blumstein L, Donaldson MH, et al. Accuracy and cost-effectiveness of a one-tube, three-color method for obtaining absolute CD4+ counts and CD4:CD8 ratios. Am J Clin Pathol 1994;101:279-82.

36. Nicholson JK, Jones BM, Hubbard M. CD4+ T-lymphocyte determinations on whole blood specimens using a single-tube, three-color assay. Cytometry 1993;14:685-9.

37. CDC. Update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR 1988;37:377-82,387-8.

38. CDC. 1988 Agent summary statement for human immunodeficiency virus and report on laboratory- acquired infection with human immunodeficiency virus. MMWR 1988;37(No. SS-4):1-22.

39. CDC. Recommendations for prevention of HIV transmission in health-care settings. MMWR 1987;36(2S):S1-S18.

40. CDC. Acquired immunodeficiency syndrome (AIDS): precautions for clinical and laboratory staffs. MMWR 1982;31:577-80.

41. CDC. Acquired immunodeficiency syndrome (AIDS): precautions for health-care workers and allied professionals. MMWR 1983;32:450-2.

42. CDC. Recommendations for preventing transmission of infection with human T-lymphotropic virus type III/lymphadenopathy-associated virus in the workplace. MMWR 1985;34:681-95.

43. CDC and NIH. Biosafety in microbiological and biomedical laboratories. 3rd ed. US Department of Health and Human Services, 1993.

44. National Committee for Clinical Laboratory Standards. Protection of laboratory workers from infectious disease transmitted by blood, body fluids, and tissue. Wayne, PA: National Committee for Clinical Laboratory Standards, 1991. NCCLS document no. M29-T2.

45. Nicholson JKA, Browning SW, Orloff SL, McDougal JS. Inactivation of HIV-infected H9 cells in whole blood preparations by lysing/fixing reagents used in flow Cytometry. J Immunol Methods 1993;160:215-8.

46. Cory JM, Rapp R, Ohlsson-Wilhelm BM. Effects of cellular fixatives on human immunodeficiency virus production. Cytometry 1990;11:647-51.

47. Aloisio CH, Nicholson JKA. Recovery of infectious human immunodeficiency virus from cells treated with 1% paraformaldehyde. J Immunol Methods 1990;128:281-5.

48. Lifson JD, Sasaki DT, Engleman EG. Utility of formaldehyde fixation for flow Cytometry and inactivation of the AIDS-associated retrovirus. J Immunol Methods 1986;86:143-9.

49. Martin LS, Loskoski SL, McDougal JS. Inactivation of human T-lymphotropic virus type III/ lymphadenopathy-associated virus by formaldehyde-based reagents. Appl Environ Microbiol 1987;53:708-9.

50. National Committee for Clinical Laboratory Standards. Additives to blood collection devices: EDTA. Wayne, PA: National Committee for Clinical Laboratory Standards, 1989. NCCLS document no. H35-P.

51. National Committee for Clinical Laboratory Standards. Reference leukocyte differential count (proportional) and evaluation of instrumental methods. Wayne, PA: National Committee for Clinical Laboratory Standards, 1992. NCCLS document no. H20-A.

52. Paxton H, Bendele T. Effect of time, temperature, and anticoagulant on flow Cytometry and hematological values. Ann NY Acad Sci 1993;677:440-3.

53. Nicholson JK, Green TA, Collaborating Laboratories. Selection of anticoagulants for lymphocyte immunophenotyping: effect of specimen age on results. J Immunol Methods 1993; 165:31-5.

54. National Committee for Clinical Laboratory Standards. Procedures for the collection of diagnostic blood specimens by venipuncture. 2nd ed. Approved Standard. Wayne, PA: National Committee for Clinical Laboratory Standards, 1984. NCCLS publication no. H3-A2

55. Shield CF III, Manlett P, Smith A, Gunter L, Goldstein G. Stability of human leukocyte differentiation antigens when stored at room temperature. J Immunol Methods 1983;62:347-52.

56. McCoy JP, Jr, Carey JL, Krause JR. Quality control in flow Cytometry for diagnostic pathology: 1. Cell surface phenotyping and general laboratory procedures. Am J Clin Pathol 1990;93 (suppl 1):S27-S37.

57. Ekong T, Kupek E, Hill A, Clark C, Davies A, Pinching A. Technical influences on immunphenotyping by flow Cytometry : the effect of time and temperature of storage on the viability of lymphocyte subsets. J Immunol Methods 1993;164:263-73.

58. Koepke JA, Landay AL. Precision and accuracy of absolute lymphocyte counts. Clin Immunol Immunopathol 1989;52:19-27.

59. Nicholson JKA, Jones BM, Cross D, McDougal S. Comparison of T and B cell analysis on fresh and aged blood. J Immunol Methods 1984;73:29-40.

60. Weiblen BJ, Debell K, Giorgio A, Valeri CR. Monoclonal antibody testing of lymphocytes after overnight storage. J Immunol Methods 1984;70:179-83.

61. Schenker EL, Hultin LE, Bauer KD, Ferbas J, Margolick JB, Giorgi JV. Evaluation of a dual-color flow Cytometry immunophenotyping panel in a multicenter quality assurance program. Cytometry 1993;14:307-17.

62. Knapp W, Dorken K, Gilks WR, et al., eds. Leukocyte typing IV: white cell differentiation antigens. Oxford: Oxford University Press, 1989.

63. Mercolino TJ, Connelly MC, Meyer EJ, et al. Immunologic differentiation of absolute lymphocyte count with an integrated flow cytometric system: a new concept for absolute T-cell subset determinations. Cytometry 1995;22:48-59.

64. Mandy FF, Bergeron M, Recktenwald D, Izaguirre CA. A simultaneous three-color T-cell subsets analysis with single laser flow cytometers using T-cell gating protocol. Comparison with conventional two-color immunophenotyping method. J Immunol Methods 1992;156:151-62.

65. Nicholson JKA, Hubbard M, Jones BM. Use of CD45 fluorescence and side-scatter characteristics for gating lymphocytes when using the whole blood lysis procedure and flow Cytometry. Cytometry 1996;26:16-21.

66. Loken MR, Brosnan JM, Bach BA, Ault KA. Establishing optimal lymphocyte gates for immunophenotyping by flow Cytometry. Cytometry 1990;11:453-9.

67. Ekong T, Gompels M, Clark C, Parkin J, Pinching A. Double-staining artifact observed in certain individuals during dual-colour immunophenotyping of lymphocytes by flow Cytometry. Cytometry 1993;14:679-84.

68. Margolick JB, Scott ER, Odaka N, Saah AJ. Flow cytometric analysis of gamma delta T-cells and natural killer cells in HIV-1 infection. Clin Immunol Immunopathol 1991;58:126-38.

69. DePaoli P, Gennari D, Martelli P, et al. A subset of lymphocytes is increased during HIV-1 infection. Clin Exp Immunol 1991;83:187-91.

70. Kringle RO, Johnson GF. Statistical procedures. In: Tietz N, ed. Textbook of clinical chemistry. Philadelphia, PA: WB Saunders Company, 1986:287-355.

71. Steindel SJ. Method comparison-a new look. American Society of Clinical Pathologist Generalist Clinical Chemistry Tech Sample No. G-8. Chicago, IL, 1984.

72. National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples. Wayne, PA: National Committee for Clinical Laboratory Standards, 1995. NCCLS publication no. EP9-A.

73. National Committee for Clinical Laboratory Standards. Preliminary evaluation of quantitative clinical laboratory methods. 2nd ed. Wayne, PA: National Committee for Clinical Laboratory Standards, 1993. NCCLS publication no. EP10-T2.

74. Galen RS, Peters T, Jr. Analytical goals and clinical relevance of laboratory procedures. In: Tietz N, ed. Textbook of Clinical Chemistry. Philadelphia, PA: WB Saunders Company, 1986: 387-409.

75. Peters Jr T, Westgard JO. Evaluation of methods. In: Tietz N, ed. Textbook of clinical chemistry. Philadelphia, PA:W.B. Saunders Company, 1986:410-23.

76. Westgard JO, de Vos DJ, Hunt MR, et al. Concepts and practices in the selection and evaluation of methods. Am J Med Technol;1978;44:290-300,420-30,552-71,727-42,803-13.

77. CDC. Results of the 1995 T-lymphocyte immunophenotyping questionnaire survey mailed to laboratories participating in the Model Performance Evaluation Program. Model Performance Evaluation Program publication, 1996;16.

78. Nicholson JKA, Velleca WM, Jubert S, Green TA, Bryan L. Evaluation of alternative CD4 technologies for the enumeration of CD4 lymphocytes. J Immunol Methods 1994;177:43-54.

79. Paxton H, Pins M, Denton G, McGonigle AD, Meisner PS, Phair JP. Comparison of CD4 cell count by a simple enzyme-linked immunosorbent assay using the TRAx CD4 test kit and by flow Cytometry and hematology. Clin Diag Lab Immunol 1995;2:104-14.

80. Denny TN, Jensen BD, Gavin EI, et al. Determination of CD4 and CD8 lymphocyte subsets by a new alternative fluorescence immunoassay. Clin Diag Lab Immunol 1995;2:330-6.

81. Robinson JE, Blum S, Koch T. Performance of the Imagn ï 2000 as compared to four color flow Cytometry. Cytometry 1996;1:85(P5).

82. Bergeron M, Mandy F, Chabot C, et al. Spatial Cytometry is an option available for reporting absolute CD4+ T-cell numbers. Cytometry 1996;1:85(P6).

83. Gertis K, Jenkins A, Folds JD. Whole blood sample stability when assaying CD4+ and CD8+ cells on the Imagn ï 2000. Cytometry (Communications in Clinical Cytometry) 1996;1:85(P7).

84. Coley T, Landay A. Internal and external quality control on the Imagn ï 2000. Cytometry (Communications in Clinical Cytometry) 1996;1:85(P8).

85. Johnson D, Hirschkorn D, Busch MP. Evaluation of four alternative methodologies for determination of absolute CD4+ lymphocyte counts. The National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study. J Acquir Immune Defic Syndr Human Retrovirol 1995; 10:522-30.

86. Rosner E, Siragusa MT. Laboratory standardization in CD4 testing: results of a nationwide impact evaluation study. Cytometry (Communications in Clinical Cytometry) 1996;1:78(A1).

87. Harwell, TS. Are there differences between laboratories that use or fail to use CDC's guidelines to measure CD4+ and CD8+ T-cells? Cytometry 1995;21:256-7.

88. Giorgi JV, Ho HN, Hirji K, et al. CD8+ lymphocyte activation at human immunodeficiency virus type 1 seroconversion: development of HLA-DR+ CD38- CD8+ cells is associated with subsequent stable CD4+ cell levels. J Infect Dis 1994;170:775-81.

89. College of American Pathologists, Commission on Laboratory Accreditation. Inspection check-list (Flow Cytometry, Section 11). Northfield, Illinois: College of American Pathologists, 1996.


Back | Next
Table of Contents

  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication Morbidity and Mortality Weekly Report.
 

 

Advertisement