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Antinuclear Antibody (ANA) Screen Test

The antinuclear antibody (ANA) screen detects autoantibodies against nuclear components and is the principal first-line test for suspected systemic autoimmune disease, particularly systemic lupus erythematosus, for which it is highly sensitive.

1

Biomarkers

Blood (serum)

Sample

2–4 business days

Turnaround

No

Fasting

What is the ANA Screen test?

The ANA Screen detects antinuclear antibodies, the principal first-line marker for suspected systemic autoimmune (connective tissue) disease. It is ordered when the clinical picture — such as arthralgia, rash, photosensitivity, serositis, or multisystem symptoms — raises the possibility of a condition like systemic lupus erythematosus. Within autoimmune assessment, the ANA screen is a highly sensitive but non-specific gateway test. It is especially useful for its high negative predictive value in SLE: a negative result makes SLE unlikely. A positive result, however, must be interpreted against the titre, the immunofluorescence pattern, and the clinical context, because low-titre positives are common in healthy people, increase with age, and occur in infections and other conditions. A meaningful positive is followed by specific autoantibody testing directed by the pattern and titre to characterise the underlying disease. Indirect immunofluorescence on HEp-2 cells is the reference method; immunoassay-based screens are also used and may need confirmation. The ANA is interpreted with inflammatory markers, complement, and the specific antibody profile rather than in isolation.

What does the ANA Screen test measure?

1
ANA(Antinuclear Antibody)
Range: Negative; positives reported with a titre (e.g. 1:40, 1:80, 1:160, 1:320) and, by immunofluorescence, a staining pattern # REVIEWER FLAG: Positivity threshold, titre reporting, and whether the screen is by indirect immunofluorescence (IFA) or immunoassay are method-dependent — reviewer to confirm against Access Medical Laboratories' methodology and cut-off.Optimal: A negative result is the expected normal; there is no target titre above negativetitre / positive/negative

Antinuclear antibodies are autoantibodies directed against components of the cell nucleus, including DNA, histones, and various nuclear proteins. They arise from a loss of immune self-tolerance and are a hallmark of systemic autoimmune (connective tissue) diseases, though they also occur in healthy individuals — increasingly with age — and in infections, other autoimmune conditions, and with certain drugs. Indirect immunofluorescence on HEp-2 cells is the reference method, yielding both a titre and a staining pattern that can suggest particular antibody specificities.

The ANA screen is the principal first-line test for suspected systemic autoimmune disease, particularly systemic lupus erythematosus, for which it is highly sensitive. Because it is not specific and a low-titre positive is common in healthy people, a positive result is interpreted in the clinical context and followed by specific antibody testing (such as anti-dsDNA, anti-Sm, anti-Ro/La, anti-centromere, anti-Scl-70) guided by the titre and pattern. A negative ANA makes SLE unlikely but does not exclude all autoimmune disease.

Why is the ANA Screen test ordered?

  • Investigation of suspected systemic lupus erythematosus or other connective tissue disease with suggestive multisystem features
  • Evaluation of unexplained arthralgia or arthritis with features suggesting an autoimmune rather than degenerative cause
  • Assessment of suspected Sjögren's syndrome, systemic sclerosis, dermatomyositis, or mixed connective tissue disease, followed by pattern-directed specific testing
  • Workup of unexplained multisystem symptoms — rash, photosensitivity, serositis, cytopenias, or renal involvement — where autoimmunity is considered
  • Investigation of suspected drug-induced lupus, interpreted with the medication history and anti-histone antibodies
  • Evaluation of Raynaud's phenomenon with features suggesting an underlying connective tissue disease
  • Assessment where a highly sensitive screen is wanted to help exclude SLE, given the strong negative predictive value

Sample collection and turnaround

Sample type

Blood (serum)

Fasting required

No

Collection method

Venipuncture at patient service centre

Turnaround

2–4 business days

Collection notes

No special preparation required. Document relevant medications (e.g. hydralazine, procainamide), recent infection, and the clinical features prompting testing, as these guide interpretation of a positive result. A positive screen is typically followed by pattern- and titre-directed specific autoantibody testing.

Specimen requirements

Minimum 0.5 mL serum. Separate serum from cells per Access Medical Laboratories protocol. Specimen stable refrigerated; follow Access Medical Laboratories transport guidelines.

What can affect ANA Screen results?

elevatesAge and healthy-population positivity

Low-titre ANA positivity is common in healthy individuals and increases with age and in women, so a low-titre positive without clinical features is often not significant.

variableAssay method (immunofluorescence vs immunoassay)

Indirect immunofluorescence on HEp-2 cells is the reference method and provides titre and pattern, while immunoassay screens can differ in sensitivity and specificity and may miss or over-call certain patterns; method affects interpretation.

elevatesInfections and inflammatory illness

Acute and chronic infections and other inflammatory states can transiently induce ANA positivity that does not reflect a connective tissue disease.

elevatesCertain medications (drug-induced ANA)

Drugs such as hydralazine, procainamide, and some others can induce ANA and drug-induced lupus, typically with anti-histone antibodies. Medication history should be documented.

elevatesOther autoimmune and organ-specific conditions

ANA positivity occurs in autoimmune thyroid and liver disease and other conditions, so a positive result is not specific to connective tissue disease and requires clinical correlation.

variableLow-titre positivity without disease

A positive ANA at low titre frequently occurs without any autoimmune disease, so the titre and pattern, not merely positivity, guide whether the result is clinically meaningful.

What do ANA Screen results mean?

Elevated

A positive ANA, particularly at higher titre (e.g. 1:160 or above) with a clinically relevant pattern, supports a systemic autoimmune disease and prompts specific autoantibody testing guided by the pattern — for example anti-dsDNA and anti-Sm for SLE, anti-centromere or anti-Scl-70 for systemic sclerosis, anti-Ro/La for Sjögren's. The result is interpreted with the clinical picture.

Normal

A negative ANA makes systemic lupus erythematosus unlikely given the test's high sensitivity, though it does not exclude all autoimmune disease. Where clinical suspicion remains high, method limitations and specific antibodies (some of which can occur with a negative screen) should be considered.

Reduced

Not applicable — ANA is reported as negative or positive with a titre rather than as a graded low value.

Note: The ANA screen is sensitive but non-specific: low-titre positives are common in healthy people and rise with age, and positivity occurs in infections, other autoimmune conditions, and with certain drugs. It must be interpreted with the titre, pattern, and clinical context, and a meaningful positive is followed by pattern-directed specific antibody testing. Method (immunofluorescence vs immunoassay) affects sensitivity and reporting, and a negative result does not exclude all connective tissue disease.

Frequently asked questions

It detects antinuclear antibodies, autoantibodies against components of the cell nucleus. It is the principal first-line test for suspected systemic autoimmune (connective tissue) disease, particularly systemic lupus erythematosus.

How to access the ANA Screen test

The ANA Screen reference page is free and open to all practitioners. Create a free practitioner account to see pricing, save tests to your list, and generate requisition forms. Verification takes 1–2 business days.

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