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Simvastatin-Neutralizing IgM Antibodies, Serum/Plasma — Qualitative

Published: August 9, 2026Updated: August 17, 2026

A qualitative blood test that detects IgM antibodies capable of interfering with simvastatin, which can occur in some statin-associated autoimmune muscle reactions.

Quick summary

["Detected antibodies may help explain severe muscle injury or weakness associated with simvastatin."]

Medically reviewed by WellAlly Editorial TeamLast reviewed August 17, 2026Editorial policy

Key facts at a glance

LOINC
72951-7
Short code
Simvastatin (neut) IgM SerPl Ql FC
Synonyms
Simvastatin (neut) IgM SerPl Ql FC
Category
liver
Sample
serum
Container
Red-top tube (SST)
Units
N/A
Ref low
10
Ref high
40
Critical range
— – 500 N/A
Fasting
false
Population
adult
Sex
all
Age range
18–65 years
Method
flow-cytometry
CPT
84484
SNOMED
302774002
Specimen volume
5 mL
Stability
Room temperature: 4h, Refrigerated: 24h, Frozen: 7d
Hemolysis max
500
Lipemia max
1000
Icterus max
500
TAT
4–24 hours
Order
routine

What is this test?

This test looks for simvastatin-neutralizing IgM antibodies in serum or plasma. These antibodies are occasionally found in people with statin-associated immune-mediated muscle disease.

Why might I need this test?

It may be ordered when a patient develops unexplained muscle pain, weakness, dark urine, or elevated muscle enzymes after taking simvastatin or another statin. The result can help doctors evaluate whether an immune reaction to the medication is contributing to muscle injury.

How is the test performed?

A blood sample is collected, and the laboratory tests the serum or plasma for the presence of simvastatin-neutralizing IgM antibodies. The result is reported as detected or not detected.

How do I prepare for the test?

No special preparation is usually required. Tell your healthcare professional which statin you take, when you started it, and any recent changes in dose or medication.

Reference range

Adult: 10-40 U/LN/A

Specimen: serum

No special preparation required. Avoid fatty meals before the test if possible.

Clinical interpretation

How abnormal results are interpreted and what conditions they suggest.

Detecting these antibodies may support a diagnosis of statin-associated immune-mediated necrotizing myopathy, particularly when severe muscle weakness, muscle pain, or muscle injury is present. A positive result should be interpreted with symptoms, medication timing, laboratory findings, and other clinical evidence. A negative result does not completely exclude a statin-related immune reaction, especially if the test is performed after treatment has stopped.

Short name

Simvastatin-Neutralizing IgM Antibodies

Frequently asked questions

What are simvastatin-neutralizing IgM antibodies?
They are immune-system antibodies that can bind to and interfere with simvastatin. In some people, their presence is associated with an autoimmune muscle reaction rather than ordinary medication side effects.
What symptoms may lead to this test being ordered?
Doctors may order it for unexplained muscle pain or weakness, dark-colored urine, or elevated muscle enzymes after starting a statin. Severe or progressive symptoms require prompt medical evaluation.
Does a positive result mean I must stop simvastatin?
A positive result may influence treatment decisions, but medication changes should be made with your healthcare professional. If you have severe muscle pain, weakness, or dark urine while taking simvastatin, seek urgent medical advice.
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 17, 2026. · Read our editorial policy