The Luminex Newborn Screening Solution

The Luminex Newborn Screening SolutionOne Punch – Four Results.Run on the NeoPlex® System, the Luminex Newborn Screening System empowers you to generate fourresults for commonly tested analytes with one blood spot punch.T4TSH17-OHPIRTThyroxine (T4)Congenital Hypothyroidism (CH)Thyrotropin (hTSH)Congenital Hypothyroidism (CH)17-alpha-OH-progesterone (17-OHP)Congenital Adrenal Hyperplasia (CAH)Immunoreactive Trypsinogen (IRT)Cystic Fibrosis (CF)The assay can be set up to report any combination of the analytes listed above, depending on your specific needs. Results foreach analyte may be reported in serum or blood units. Excellent sensitivity and specificity data have been obtained with thesystem and are highlighted in the following graphs.

Precision and Sensitivity DataAnalyte Units % CV LoDT4 (µg/dL) 11.4 1.6170-HP(ng/mL)13.113.12.5IRT (ng/mL) 12.9 1.0TSH(µlU/mL)13.910.10.930Scatter Plot with Deming Fit600Scatter Plot with Deming Fit25500T4 (ug/dL) - NeoPlex42015105IdentityDeming fit(1.57 + 0.99x)TSH (uIU/ml) - NeoPlex4400300200100IdentityDeming fit(2.23 + 0.80x)00 5 10 15 20 25 30T4 (ug/dL) - Comparative Method00 100 200 300 400 500 600TSH (uIU/ml) - Comparative MethodFigure 1. Deming regression analysis of NeoPlex4 T4 (y-axis) vs comparativemethod T4 (x-axis) including samples from screening population andconfirmed CH.Figure 2. Deming regression analysis of NeoPlex4 TSH (y-axis) vscomparative method TSH (x-axis) including samples from screeningpopulation and confirmed CH.Scatter Plot with Deming Fit350Scatter Plot with Deming Fit30017-OHP (ng/ml) - NeoPlex4IdentityDeming fit(0.77 + 1.01x)IRT (ng/ml) - NeoPlex4250200150100500IdentityDeming fit(4.02 + 1.12x)0 50 100150 20017-OHP (ng/ml) - Comparative Method-50-50 0 50 100 150 200 250 300 350IRT (ng/ml) - Comparative MethodFigure 3. Deming regression analysis of NeoPlex4 17-OHP (y-axis) vscomparative method 17-OHP (x-axis) including results from screening andconfirmed CAH.Figure 4. Deming regression analysis of NeoPlex4 IRT (y-axis) vscomparative method IRT (x-axis) including results from screening andconfirmed CF.HEADQUARTERS12212 Technology BlvdAustin, TX 78727 USATel: 512.219.8020Fax: 512.219.5195www.luminexcorp.cominfo@luminexcorp.comCANADATel: +1.416.593.4323Fax: +1.416.593.1066EUROPETel: +31.162.408333Fax: +31.162.408337CHINATel: +86.21.616.50809Fax: +86.21.616.50811JAPANTel: +81.3.5545.7440Fax: +81.3.5545.0451AUSTRALIATel: +61.7.3273.0273Fax: +61.7.3273.0274BR_371.01_0612