Fig 1.
BD FACSLyric clinical evaluation flowchart.
T-, B-, and NK cells were stained with BD Multitest reagents for testing of the 4 protocols depicted from the left to the right side: 1. Method comparison; 2. Inter-laboratory variability; 3. Determination of the reference intervals and 4. Evaluation of the specimen and stained sample storage. The summary for each protocol includes the number of specimens enrolled and cohort of origin, followed by the instrument(s) used for acquisition of the stained sample.
Fig 2.
Deming regression and Bland-Altman plots of the absolute counts of T-, B-, and NK lymphocytes identified with the BD Multitest 6-Color TBNK reagent.
This is the Fig 2 legend. The T- cells (CD3+, CD3+CD4+ and CD3+CD8+) shown as A, B, and C; the NK lymphocytes in D, and the B-lymphocytes are depicted in E stained with BD Multitest 6-Color TBNK reagent. The Deming regression are the upper plots with identity line (grey) and the Weighted Deming regression line (red) of each subset. The x-axis depicts BD FACSCanto II cell counts and the y-axis shows the BD FACSLyric counts. The Bland-Altman graphs are the lower plots of each subset, with the bias line (blue solid line) and the upper and lower limits of agreement (blue dotted lines). For these plots, the x-axis corresponds to the average of the lymphocyte marker, and the y-axis represents the estimated percent difference of the absolute counts between systems.
Table 1.
T-, B-, and NK cell Deming regression results determined using BD Multitest reagents.
Table 2.
Agreement at the CD4 clinical cutoff of 200 cells/μL.
Table 3.
Predicted bias interval at the CD4 clinical cutoff.
Table 4.
Inter-laboratory total precision lymphocyte subset results with BD Multitest 6-color TBNK reagent.
Fig 3.
Inter-laboratory total precision per site.
The variability per site is illustrated with the BD Multitest 6-color TBNK reagent total precision. The total precision results using CD Chex Plus control materials for the CD4 low are shown on the upper plot, and the total precision for CD4 normal on the bottom plot. The x-axis shows the participating laboratoriers per number and color. The y-axis displays the percentage of coefficient of variance (%CV) and the upper CV limit.
Table 5.
Specimen and stained sample storage biases at different time points using BD Multitest reagents.
Table 6.
Lymphocyte subset reference intervals for the BD Multitest reagents.