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Ortho-mune OKT4A (CD4) Monoclonal Antibody (Murine) FITC Conjugate is used to identify and enumerate the percentage of CD4+ human T lymphocytes in whole blood by flow cytometry. Identification and enumeration of abnormal levels of CD4lymphocytes may be clinically significant in the prognosis of secondary immunodeficiency diseases (acquired immunodeficiency syndrome [AIDS]). AIDS is characterized by a severe reduction in T helper CD3+CD4+) lymphocytes and a decrease in the CD4:CD8 ratio. The CD4:CD8 ratio has been used as a predictor of time to the development of AIDS. CD4 counts should also be determined using a CD3/CD4 combination reagent to eliminate monocyte contamination (CD3-CD4+dim). CD4+lymphocytes (expressed as an absolute number, a percentage of lymphocytes or as a ratio of CD4+ to CD8+ T lymphocytes) represents the best single predictor of the progression of AIDS. CD4+ lymphocyte numbers usually start to decline relatively soon after human immunodeficiency virus (HIV) infection.

Ortho-mune OKT4A Monoclonal Antibody (Murine) FITC Conjugate contains the purified monoclonal antibody OKT4A conjugated to the fluorochrome fluorescein isothiocyanate.

Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotying of human lymphocytes in whole blood by flow cytometry using Orthomune OK-COMBO immunophenotyping reagents. Ortho-mune OK-COMBO immunophenotyping reagents are blends of two purified monoclonal antibodies conjugated to fluorescein isothiocyanate and phycoerythrin, respectively. The negative control is used to check for nonspecific background staining and to set the negative/positive rergions of the fluorescent cytograms.

Ortho-mune OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine) is a blend of murine monoclonal antibodies, not specific for human cellular antigens, conjugated to the fluorochromes, fluorescein isothiocyanate (FITC) and phycoerythrin (PE), respectively.

Ortho-mune OKB19A PE Conjugate is intended for use in identification and enumeration of CD19+ human B lymphocytes in whole blood by flow cytometry.

Ortho-mune OKB19A Monoclonal Antibody (Murine) Phycoerythrin (PE) Conjugate contains the purified monoclonal antibody OKB19A conjugated to the fluorochrome phycoerythrin.

Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The intended use is the same as the intended use of the predicate device, Simultest CD3/CD4 (Leu-4/3a) commercially distributed by Becton Dickinson Immunocytometry Systems.

Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT4A conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.

Ortho-mune OK-COMBO CD4-FITC/CD8-PE is intended for use in identification and enumeration of CD4+ and CD8+ human T lymphocytes in whole blood by flow cvtometry. The intended use is the same as the intended use of the predicate device. Simultest CD4/CD8 (Leu-3a/2a) commercially distributed by Becton Dickinson Immunocytometry Systems.

Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT4A and OKT8 conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.

Ortho-mune OK-COMBO CD3-FITC/CD8-PE is intended for use in identification and enumeration of CD3+ and CD8+ human T lymphocytes in whole blood by flow cvtometry. The intended use is the same as the intended use of the predicate device(s), Ortho-mune OKT3 Monoclonal Antibody (Murine) FITC Conjugate, and Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin conjugate.

Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT8 conjugated to the fluorochromes fluorescein isothiccyanate and phycoerythrin respectively.

Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System is intended to be used to calibrate and verify calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE.

Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System, contains a Calibrator Bead Suspension for absolute lymphocyte count calibration and Verifier Bead Suspensions (I, II and III) to verify accuracy of absolute count calibration. The Calibrator Bead Suspension is manufactured as known "events"/unit volume (i.e. the Calibration Number) in the form of microparticle beads suspended in a proprietary buffer. The size of the microparticles has been selected to emulate the range of size of leukocytes detected by the ORTHO CYTORONABSOLUTE under specified gating conditions. The Verifier Bead Suspensions (I, II and III), are composed of materials identical to the Calibrator Bead Suspension and collectively provide a range of particle bead concentrations. The target values chosen approximate values expected from patients with low (Verifier I), normal (Verifier II) and high (Verifier III) white blood cell counts, The Verifiers are used to verify accuracy of the absolute respectively. lymphocyte count calibration immediately following calibration and are also used as daily quality control verification that the ORTHO CYTORONABSOLUTE is in calibration. A properly calibrated instrument will provide absolute counts within + 10% of the labeled events/uL for each Verifier supsension. In the context of immune status monitoring, absolute cell count is defined as the number of cells per unit volume. The ORTHO CYTORONABSOLUTE uses precision stepper motors to deliver diluted sample to the instrument's flow cell at a constant rate. Since constant flow rate means movement of a fixed volume per unit time, analysis time determines the volume of sample analyzed. Calibration of the ORTHO CYTORONABSOLUTE consists of setting analysis time such that a volume corresponding to 1 uL of undiluted sample is examined. Ortho-Count Calibrator Bead Suspension, representing a known number of particles per unit volume (i.e. events/uL) at the same dilution as used for testing samples, is counted until its "Calibration Number" is reached; the instrument is set to this analysis time. In subsequent analyses events are to passage of the equivalent of 1 uL of undiluted sample the instrument flowcell. As a result of this calibration, sample results can be read in absolute count, i.e. "events"/uL.

ORTHO™ ImmunoCount Flow Cytometry System is intended to be used for lymphocyte immunophenotyping. Results may be reported as either percent positive cells, or as absolute counts of lymphocytes and lymphocyte subsets.

ORTHO ImmunoCount Flow Cytometry System consists of ORTHO CytoronAbsolute Laser Flow Cytometer, ImmunoCount II Software, ORTHO TRIO Monoclonal Antibodies for lymphocyte immunophenotyping, and Ortho-Count Calibration Kit for calibration and verification of system calibration.