4 The diagnostic tests

The interventions

LISA‑TRACKER ELISA kits

4.1 LISA‑TRACKER enzyme‑linked immunosorbent assay (ELISA) kits are manufactured by Theradiag and distributed in the UK by Alpha Laboratories. There are 6 LISA‑TRACKER ELISA kits relevant to this assessment. Two kits measure the levels of free antibodies to tumour necrosis factor (TNF)‑alpha inhibitor, 2 kits measure the levels of free TNF‑alpha inhibitor and 2 kits measure the levels of both free TNF‑alpha inhibitor and antibodies to TNF‑alpha inhibitor.

4.2 The LISA‑TRACKER ELISA kits consist of pre‑coated strips of microtitre plate (96 wells), reagents, wash buffer, standards and controls. The assays can be run simultaneously or individually on any manual or automated standard ELISA‑based processor platform.

IDKmonitor ELISA kits

4.3 IDKmonitor ELISA kits (previously called Immundiagnostik TNFα‑blocker ELISA kits) are manufactured by Immundiagnostik AG and distributed in the UK by Biohit Healthcare. There are 6 IDKmonitor ELISA kits relevant to this assessment. Two kits measure the levels of free anti‑drug antibodies, 2 kits measure the levels of total anti‑drug antibodies (free antibodies and antibodies bound to the drug), and 2 kits measure the levels of free TNF‑alpha inhibitor.

4.4 The kits consist of strips of pre‑coated microtitre plate (96 wells), reagents, buffers, standards (drug level ELISAs only) and controls. The ELISAs can be done manually or run on an automated ELISA processor.

Promonitor ELISA kits

4.5 Promonitor ELISA kits are manufactured by Proteomika and distributed in the UK by Grifols UK. There are 4 Promonitor ELISA kits relevant to this assessment. Two of these kits measure the levels of free anti‑drug antibodies and 2 kits measure the levels of free TNF‑alpha inhibitor.

4.6 The kits consist of strips of pre‑coated microtitre plate (96 wells), reagents, buffers, standards, controls and ELISA cover films. The ELISAs can be done manually or run on an automated ELISA processor.

The comparator: no testing

4.7 The comparator for this assessment is treatment decisions based on clinical judgement without measuring levels of TNF‑alpha inhibitor or antibodies to TNF‑alpha inhibitor.

  • National Institute for Health and Care Excellence (NICE)