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Table 4 Assay selectivity

From: A competitive ligand-binding assay for the detection of neutralizing antibodies against dostarlimab (TSR-042)

Sample type

Lot

NAb unspiked

NAb spiked at LPC

ECL

%CV

Plate CP

Condition

ECL

%CV

Plate CP

Condition

Cancer

1

1113

2.9

1573

< CP

2745

7.2

1573

> CP

Cancer

2

1499

3.5

1573

< CP

2644

0.1

1573

> CP

Cancer

3

1917

0.8

1573

> CP

2949

5.7

1573

> CP

Cancer

4

1352

2.1

1573

< CP

2820

4.9

1573

> CP

Cancer

5

1389

9.5

1573

< CP

2390

6.4

1573

> CP

Cancer

6

1269

0.8

1573

< CP

3382

4.9

1573

> CP

Cancer

7

1005

1.4

1573

< CP

2402

4.4

1573

> CP

Cancer

8

998

7.4

1573

< CP

2362

1.2

1573

> CP

Cancer

9

967

13.8

1573

< CP

1932

10.7

1573

> CP

Cancer

10

836

11.9

1573

< CP

2478

1.3

1573

> CP

Hemolyzed

1

1071

12.5

1573

< CP

2308

4.0

1573

> CP

Hemolyzed

2

1144

0.8

1573

< CP

2745

19.9

1573

> CP

Hemolyzed

3

893

9.0

1573

< CP

1717

3.4

1573

> CP

Hemolyzed

4

802

0.4

1573

< CP

2066

10.7

1573

> CP

Hemolyzed

5

553

2.0

1573

< CP

691

6.0

1573

< CP

Lipemic

1

2561

6.3

1573

> CP

3486

5.7

1573

> CP

Lipemic

2

1212

7.3

1573

< CP

2042

11.1

1573

> CP

Lipemic

3

813

1.4

1573

< CP

1652

5.2

1573

> CP

Lipemic

4

1525

6.0

1573

< CP

2758

1.0

1573

> CP

Lipemic

5

1010

0.8

1573

< CP

1916

10.6

1573

> CP

  1. CP, cut point; %CV, coefficient of variation; ECL, electrochemiluminescence readout; LPC, low-positive control; NAb, neutralizing antibody