Humira - ADALIMUMAB LEVELS AND ANTI-ADALIMUMAB ANTIBODY LEVELS

Sample type

Serum

Use

Monitor antiadalimumab therapy for individuals with Crohn’s disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of antiadalimumab antibodies.

Precautions

Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Interfering factors

The ELISA immunoassay method used for adalimumab total anti-drug antibody measurement at Exeter Blood Sciences laboratory uses a streptavidin-biotin system in its design. If patients are taking large doses of Biotin (Vitamin B7), there is potential for interference in this assay with a possibility of lowered results when biotin concentration >477 nmol/L.

Pre analytical errors

1- Incorrect Analysis ordered

2- patients identification error

3- sample collection errors

Corrective action

1- Using appropriate technology.

2- Monitoring quality indicators in the lab.

3- Choosing appropriate products.

Post analytical errors

1- Report delayed

2- Not all requested tests done

3- Sharing the results of patients or writing the result incorrectly.

Corrective action

1- Done Accurate Reports after doing tests

2- Assure that the prescribed preventive maintenance for the instruments is performed

3- Attention when delivered the results of patient and write them in the reports

Reference Range

Adalimumab Drug Levels (micrograms per ml)Minimum Trough level = 4.9 micrograms per ml

Anti-Adalimumab Antibodies (nanograms per ml)Negative <10 nanograms/ml

Positive >10 nanograms/ml