Test Overview


This test assists in the diagnosis of autoimmune myasthenia gravis (MG) with acetylcholine receptor (AChR) antibodies.

It provides a more sensitive test for AChR antibodies that may be present in double-seronegative samples, but undetectable by standard detection methods such as radioimmunoprecipitation assay (RIPA) or enzyme-linked immunosorbent assay (ELISA).

Test Code:

AChR CBA
Synonyms:

Clustered AchR Ab, AchR Ab
Methodology:

In-house live cell-based assay (CBA)
Validation:

Laboratory Developed Test (LDT)
Reference Range:

Reported as positive or negative

Performance


Frequency:

Once a week
Expected Turnaround:

2 - 7 days
Sample Report:

Coming Soon

Our offices are only able to receive samples Mon-Fri, so samples must be shipped Mon-Thur. Samples arriving over the weekend may need to be redrawn.

Specimen


Specimen Type:

Serum
Container:

Gel barrier or red-top tube
Preferred Volume:

3 mL
Minimum Volume:

0.5 mL

Rejection Criteria:

Grossly hemolytic, lipemic, or icteric.
If the sample arrives at room temperature.
Collection and Processing:

No patient preparation is required for sample collection.

Draw blood in tube(s) with SST activator (5mL gold top or 8.5mL tiger top).
Invert tubes 8 times to ensure complete mixing.

Allow sample 30 minutes to clot (1 hour if red-top tube).
Centrifuge tubes at 1800 - 2200 x g for 10-15 minutes within 2 hours of collection.

Draw off serum (top layer) into aliquot tubes with pipette, ensuring not to take gel or RBC (middle/bottom layers).

Store aliquot tubes in refrigerator (2° C - 8° C) until shipping.
Specimen Handling:

Transport refrigerated (2° C - 8° C)

Specimen Stability:

24 hours room temperature (15 - 25° C)
2 weeks refrigerated (2 - 8° C)
5 months frozen (-20⁰ C) or ultra-low (-70⁰ C)

Up to 5 freeze / thaw cycles

Additional Information


  • This test was developed and its performance determined by Neurocode USA Inc. It has not been cleared or approved by the Food and Drug Administration.
  • Please indicate if patients are on immunomodulating treatments as these may interfere with testing.
  • Causal antibodies cannot be identified in about 10% of MG cases. Therefore, a positive result is specific for the diagnosis of AChR ab myasthenia gravis (MG), but a negative result does not rule out an MG diagnosis.
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