ANTICARDIOLIPIN (ANTIPHOSPHOLIPID) ANTIBODIES (IgG, IgM) PANEL

Category

SEROLOGY/ IMMUNOLOGY

Sub Category

AUTOIMMUNE

Synonyms/Aliases

CARDIOLIPIN ANTIBODIES; ANTIPHOSPHOLIPID ANTIBODIES.

Abbreviations

ACA; ACL Ab; ACA IgG, IgM.

Type

PROFILE/ PANEL (BUNDLED TESTS).

5 days

5 WORKING DAYS

Method

IMMUNOASSAY.

Temp

AMBIENT (6 HOURS), REFRIGERATED (7 DAYS), FROZEN (14 DAYS)

Setup

BATCHED.

Components Parameters

ACA IgG, ACA IgM.

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

N/A.

Reference intervals

NEGATIVE.

Clinical Utility

EVALUATION OF ANTIPHOSPHOLIPID SYNDROME (PHOSPHOLIPID ANTIBODY SYNDROME). EVALUATION OF PATIENTS WITH UNEXPLAINED THROMBOSIS, RECURRENT MISCARRIAGES ETC.

Test Limitations/ Confounders

POSITIVE RESULTS MAY OCCUR IN OTHER AUTOIMMUNE DISORDERS E.G. SLE, RHEUMATOID ARTHRITIS, SJOGREN'S SYNDROME & IN THESE CONDITIONS MAY BE ASSOCIATED WITH INCREASED THROMBOTIC RISK. TRANSIENT POSITIVITY CAN OCCUR AND REPEAT TESTING IS ADVISED AFTER 12 WEEKS TO DEMONSTRATE PERSISTENCE OF ANTIBODIES.

ANTI-HISTONE

Category

SEROLOGY/ IMMUNOLOGY

Sub Category

AUTOIMMUNE

Synonyms/Aliases

HISTONE ANTIBODY, DRUG INDUCED LE/SLE

Abbreviations

AHA.

Type

INDIVIDUAL TEST.

5 days

5 WORKING DAYS

Method

IMMUNOASSAY.

Temp

AMBIENT (6 HOURS), REFRIGERATED (7 DAYS), FROZEN (14 DAYS)

Setup

BATCHED.

Components Parameters

N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SPECIFY ANA RESULTS IF DONE.

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

EVALUATE DRUG INDUCED LUPUS.

Test Limitations/ Confounders

N/A

ANTI SMOOTH MUSCLE ANTIBODY

Category

SEROLOGY/ IMMUNOLOGY

Sub Category

AUTOIMMUNE

Synonyms/Aliases

ACTIN ANTIBODY REFLEXIVE PANEL, F-ACTIN ANTIBODY.

Abbreviations

ASMA, SOFT-SMA.

Type

INDIVIDUAL TEST.

7 days

7 WORKING DAYS

Method

IMMUNOFLUORESCENCE

Temp

AMBIENT (6 HOURS), REFRIGERATED (7 DAYS), FROZEN (14 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

AGE AND GENDER APPROPRIATE VALUES PROVIDED WITH REPORT

Clinical Utility

DIAGNOSIS OF AUTOIMMUNE LIVER DISEASE

Test Limitations/ Confounders

IMMUNE COMPLEXES IN THE SAMPLE CAUSE FALSE POSITIVE RESULTS

ANTI NUCLEAR ANTIBODIES

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.

ANTI NEUTROPHIL CYTOPLASMIC ANTIBODIES, IFA REFLEX MPO & PR3 ELISA

Category

SEROLOGY/ IMMUNOLOGY

Sub Category

AUTOIMMUNE

Synonyms/Aliases

ANTI-CYTOPLASMIC ANTIBODY, AUTOANTIBODIES TO PROTEINASE 3

Abbreviations

ANCA, pANCA, PR3, ACPA, cANCA.

Type

PROFILE/ PANEL (BUNDLED TESTS)

10 days

10 WORKING DAYS

Method

IMMUNOASSAY.

Temp

AMBIENT (24 HOURS), REFRIGERATED (3 DAYS), FROZEN (14 DAYS).

Setup

BATCHED.

Components Parameters

pANCA ,cANCA

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY.

Patient preparation

FASTING.

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

NEGATIVE.

Clinical Utility

EVALUATION OF AUTOIMMUNE NECROTIZING SMALL VESSEL VASCULITIDES.

Test Limitations/ Confounders

N/A

ANTI CYCLIC CITRULLINATED PEPTIDE

Category

Serology/ Immunology

Sub Category

Autoimmune

Synonyms/Aliases

CCP Antibody, Anti Citrullinated Antibody.

Abbreviations

ANTI CCP; ACPA; CCP IgG.

Type

Individual Test

24-48 Hrs

Within 24-48 hours.

Method

Automated Immunoassay.

Temp

Ambient (48 Hours), Refrigerated (7 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

2 ML

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 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

Method specific values are provided with report.

Clinical Utility

Evaluate Rheumatoid Arthritis (RA) as one component of a multi-criteria diagnostic process that co-opts clinical & other lab criteria (refer to current ACR/ Eular criteria for diagnosis of Rheumatoid Arthritis). It is more specific for RA than Rheumatoid factor.

Test Limitations/ Confounders

A positive result may occur in other Autoimmune Diseases. Positive results may occur years before the onset of symptoms of Rheumatoid Arthritis.

ALLERGEN, WHEAT

Category

Serology/ Immunology

Sub Category

Allergy

Synonyms/Aliases

N/A

Abbreviations

N/A

Type

Individual Test

5 days

Results ready in 5 working days

Method

Immunocap (allergen specific IgE testing).

Temp

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

No preparation required.

Sample type

Serum

Container/ preservative

Serum separator tube (SST/ Gel) or plain (red top) vacutainer.

Sample volume

At least 2 ML

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Insufficient Sample.

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

Interpretive data is provided on the report.

Clinical Utility

Assessing the likelihood of food allergy triggered by Wheat.

Test Limitations/ Confounders

Results must be interpreted in conjunction with clinical history & symptoms.

ALLERGEN, TUNA FISH

Category

Serology/ Immunology

Sub Category

Allergy

Synonyms/Aliases

N/A

Abbreviations

N/A

Type

Individual Test

5 days

Results ready in 5 working days

Method

Immunocap (allergen specific IgE testing).

Temp

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

No preparation required.

Sample type

Serum

Container/ preservative

Serum separator tube (SST/ Gel) or plain (red top) vacutainer.

Sample volume

At least 2 ML

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Insufficient Sample.

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

Interpretive data is provided on the report.

Clinical Utility

Assessing the likelihood of food allergy triggered by Tuna Fish.

Test Limitations/ Confounders

Results must be interpreted in conjunction with clinical history & symptoms.

ALLERGEN, SOYABEAN

Category

Serology/ Immunology

Sub Category

Allergy

Synonyms/Aliases

Allergen, Soybean.

Abbreviations

ALLERGEN, SOY.

Type

Individual Test

5 days

Results ready in 5 working days

Method

Immunocap (allergen specific IgE testing).

Temp

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

No preparation required.

Sample type

Serum

Container/ preservative

Serum separator tube (SST/ Gel) or plain (red top) vacutainer.

Sample volume

At least 2 ML

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Insufficient Sample.

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

Interpretive data is provided on the report.

Clinical Utility

Assessing the likelihood of food allergy triggered by Soy beans.

Test Limitations/ Confounders

Results must be interpreted in conjunction with clinical history & symptoms.

ALLERGEN, PEANUT

Category

Serology/ Immunology

Sub Category

Allergy

Synonyms/Aliases

Allergy, Groundnut.

Abbreviations

N/A

Type

Individual Test

5 days

Results ready in 5 working days

Method

Immunocap (allergen specific IgE testing).

Temp

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

No preparation required.

Sample type

Serum

Container/ preservative

Serum separator tube (SST/ Gel) or plain (red top) vacutainer.

Sample volume

At least 2 ML

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Insufficient Sample.

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

Interpretive data is provided on the report.

Clinical Utility

Assessing the likelihood of food allergy triggered by peanuts (Groundnuts).

Test Limitations/ Confounders

Results must be interpreted in conjunction with clinical history & symptoms.