Category
SEROLOGY/ IMMUNOLOGY
Sub Category
AUTOIMMUNE
Synonyms/Aliases
HEp-2; ANA BY IFA.
Abbreviations
ANA.
Type
INDIVIDUAL TEST.
3 days
3 WORKING DAYS
Method
INDIRECT IMMUNOFLUORESCENCE TEST USING HEp2 OR HEp-20-10 SUBSTRATE [WITH TITRES & PATTERN(S) FOR SCREEN POSITIVE CASES].
Temp
AMBIENT (7 DAYS), REFRIGERATED (14 DAYS), FROZEN (>30 DAYS).
Setup
BATCHED.
Components Parameters
N/A
PRE-ANALYTIC CONSIDERATIONS
Test Ordering Instructions
FILL OUT TEST REQUEST FORM FULLY & LEGIBLY.
Patient preparation
N/A.
Sample type
SERUM
Container/ preservative
SERUM SEPARATOR TUBE (SST/ GEL) OR PLAIN (RED TOP) VACUTAINER.
Sample volume
2ML.
Rejection criteria
LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE; HEMOLYZED, LIPEMIC, ICTERIC SAMPLES.
Other Instructions
CENTRIFUGE SST (SERUM GEL TUBES) WITHIN 1-2 HOURS OF COLLECTION. CENTRIFUGE RED TOP VACUTAINERS AND ALIQUOT SERUM WITHIN 1-2 HOURS OF COLLECTION. THE SEPARATION VIAL MUST BE LABELED WITH AT LEAST 2 PATIENT IDENTIFIERS AND THE SAMPLE TYPE.
Reference intervals
APPROPRIATE VALUES PROVIDED WITH REPORT.
Clinical Utility
DETECT SYSTEMIC AUTOIMMUNE RHEUMATIC DISEASES E.G. SLE, MIXED CONNECTIVE TISSUE DISEASE (MCTD), SCLERODERMA, SJÖGREN'S SYNDROME, POLYMYOSITIS ETC.. EVALUATE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) AS ONE COMPONENT OF A MULTI-CRITERIA DIAGNOSTIC PROCESS THAT CO-OPTS CLINICAL CRITERIA (REFER TO CURRENT ACR/ EULAR CRITERIA FOR DIAGNOSIS OF SLE).
Test Limitations/ Confounders
HAS LOW SPECIFICITY E.G. FALSE POSITIVES MAY OCCUR IN CHRONIC INFLAMMATORY STATES, OTHER AUTOIMMUNE DISEASES & IN SOME NORMAL INDIVIDUALS. POSITIVE RESULTS REQUIRE CLINICAL CORRELATION AND MAY REQUIRE FOLLOW-UP SPECIFIC AUTO-ANTIBODY TESTING (AS APPLICABLE) E.G. ENA PROFILE, ANTI DS-DNA, ANTI-SM ETC.