Hyper IgM-CD40L assay

Sample type

Heparinised blood samples taken from patients in the morning before 11am then doing the test within 8 hours Sample must not have been refrigerated or centrifuged

Use

Confirm a clinical diagnosis of HIGM; detect carriers; allow early diagnosis in family members

Precautions

This method does not reliably detect mosaic variants; large deletions; large duplications, inversions, or other rearrangements; or deep intronic variants. It may be affected by allele-dropout, it may not allow determination of the exact numbers of T/A or microsatellite repeats, and it does not allow any conclusion as to whether two heterozygous variants are present on the same or on different chromosome copies.

Results of this test are for investigational purposes only. The performance characteristics of this assay have been determined by LabCorp. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.

Interfering factors

This test is typically not indicated in males over 10 years of age or females beyond child-bearing age (>45 years). For questions about appropriate test selection.

The test must be performed on fresh, heparinized whole blood cells for appropriate CD40L expression on activated CD4 T cells; specimen handling instructions must be followed. T-cell activation is variable on specimens tested between 48 and 72 hours after blood collection. These specimens will be analyzed and results will be reported after the laboratory director’s review. Specimens received more than 72 hours after collection will be rejected and the assay will not be performed.

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

The normal range for IgM in the blood is around 40 – 250 mg/dL (milligrams per deciliter