Antinuclear Antibodies, (ANA Screen) w/Full Reflex Cascade

CPT CODES: 86038 (ENA Screen) & 86225 (Anti-dsDNA) & 86235 (Reflex tests)

Note: See below for full panel codes.

ORDERING rECOMMENDATION

Use to detect extractable nuclear antibodies (ENAs), also known as antinuclear antibodies (ANAs) which are of central importance of clinical diagnosis of connective tissue diseases and includes antibodies against the double-stranded DNA (dsDNA), Sm, U1RNP (RNP 70, A, C), SS-A/Ro, SS-B/La, Scl-70, Centromere B and Jo-1

specimen required

Specimen Type:

1.0 mL separated serum/plasma

Collection Tube:

Plasma Transport Tube, Request Samples

Minimum Volume:

1.0mL

Specimen Stability/Storage:

Room Temperature (15-25°C): 7 days; Refrigerated (2-8°C): 7 days or Frozen (≤ -20°C): 7 days

Unacceptable Conditions:

Shipping Requirements:

Call 866-983-0667 to schedule courier pickup

Stability:

Ambient: 8 hours; Refrigerated: 48 hours; Frozen: 30 days

devlab test code
metholodogy
Test NameTest CodeCPT Code
ENA ScreenR1000086038
Atni-dsDNAR1000186225

If ENA Screen results are Positive (>1.0 Ratio), testing will
reflex to individual tests for U1RNP, RNP70, SmD, SS-A/Ro,
SS-B/La, Centromere B, Scl-70, & Jo-1 antibodies.

Test NameTest CodeCPT Code
Anti-U1RNPR1000286235
Anti-RNP70R1000386235
Anti-SmD R1000486235
Anti-SS-A/RoR1000586235
Anti-SS-B/LaR1000686235
Anti-Centromere B R1000786235
Anti-Scl-70 R1000886235
Anti-Jo-1 R1000986235

EliA for determination of dsDNA antibodies

performed

24-36 hours from receipt (Monday – Friday)

reported

Weekly (Monday – Friday)

Option: ANA Screen without Full Reflex Cascade

ALTERNATIVE NAMES

ENA Screen and Anti-dsDNA, Connective Tissue Disease

SUBMIT WITH ORDER

Test Requisition

Results Interpretation

Positive:

Result > 1:80

Equivocal:

Results = 1:80

Negative:

Result < 1:80

Additional Information

Extractable nuclear antibodies (ENAs), also known as antinuclear antibodies (ANAs), are of central
importance to clinical diagnosis of connective tissue diseases (CTDs) and includes antibodies against
double-stranded DNA (dsDNA), Sm, U1RNP (RNP 70, A, C), SS-A/Ro, SS-B/La, Scl-70, Centromere B, and Jo-1. Incidence of specific ENAs varies across different CTDs and testing for these specific ENAs can assist physicians in diagnosing patients with specific connective tissues diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), mixed connective tissue disease (MCTD), Sjögrens syndrome, scleroderma, and polymyositis/dermatomyositis.

The following table describes clinical association of individual ENAs with various connective tissue
diseases6,7,8:

Antibodies
Detected		Lupus Specificity RatingClinical Associations(s)Other Associated Diseases
Anti-dsDNAHigh sensitivity and
specificity for SLE. Correlates
with disease activity		● SLE: 60 – 98%
● LN: 70%
● NPSLE: 44, 4-80, 6%		RA, HIV, and paravovirus B19 infections, myeloma, and type 1 autoimmune hepatitis.
Anti-SmDLow sensitivity, but high
specificity for SLE		● SLE: 20 – 40%
● LN: 14%
● MCTD: 8%		EBV infection
Anti-U1RNP
(RNP 70, A, C)		High● SLE: 30 – 40%
● MCTD: 100%		Myositis, esophageal hypomotility, sclerodactyly,
Raynaud’s phenomenon, arthralgia and arthritis.
Anti-SS-A/Ro
(60 kDa, 52 kDa)		High prognostic value for
NLE in pregnant women		● SLE: 40%
● LN: 31%
● NLE (especially CHB): 90%
● SCLE: 70 – 80%
● Discoid Lupus: 5 – 20%		Anti-SS-A/Ro and anti-SS-B/La are commonly
identified in patients with Sjögrens syndrome
With photosensitive skin rash, pulmonary disease
and lymhopenia.
Anti-SS-B/LaModerate● SLE: 10 – 15%
● LN: 14%
● Protective for LN
● SCLE: 30%
● NLE: 90%		Late-onset SLE, secondary Sjögrens syndrome and
neonatal lupus syndrome.
Test to confirm the diagnosis of Sjögrens syndrome.
Useful in patients with a positive ANA test and
suspected SLE
Anti-Scl-70Low● Scleroderma: 22 – 40%Diffuse cutaneous disease, pulmonary fibrosis,
cardiac involvement and longer disease duration;
Testing for Scl-70 may be useful in patients with
suspected Scleroderma.
Anti-Centromere-BLow● Scleroderma: 22 – 36%Associated with CREST syndrome and Raynaud’s
phenomenon, limited scleroderma, pulmonary
hypertensions, primary biliary cirrhosis.
Anti-Jo-1Highly specific, but not
sensitive for sclerodeerma		● Polymyositis/
dermatomyositis: 30%		Inflammatory myopathies with interstitial lung
disease, fever, asthma, pulmonary fibrosis and
Raynaud’s phenomenon.

CHB – congenital heart block; LN – lupus nephritis; MCTD – mixed connective tissue disease; NLE – neonatal lupus erythematosus; NPSLE
– neuropsychiatric lupus; SCLE – subacute cutaneous lupus erythematosus; SLE – Systemic lupus erythematosus