NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated.
Test Code	Test Name	Effective Date	Page #
10266	Cytosolic 5’-Nucleotidase 1A (cN-1A) Antibody (IgG)	1/10/2022
10257	Extended Myositis Specific Antibody (MSA) Panel	1/10/2022

TEST CHANGES Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated.
Test Code	Former Test Code	Test Name	Effective Date	Page #
94777		Myositis Specific 11 Antibody Panel	1/10/2022

SEND OUTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated.
Test Code	Former Test Code	Test Name	Effective Date	Page #
10449		Target Selector™ NGS Lung Panel	11/29/2021

Note: It may be 24 - 48 hours after the published effective date before this test information is available on the Online Test Directory or in Quanum™.

Announcements

cN-1A Antibody Test

Quest Diagnostics is pleased to announce the release of Cytosolic 5’-Nucleotidase 1A (cN-1A) Antibody test to provide a more comprehensive autoimmune & immunology test menu. The cN-1A Ab assay is a useful aid for the diagnosis of inclusion body myositis (IBM) as well as for differential diagnosis of IBM from other muscle diseases. IBM is the most common acquired myopathy which is more often diagnosed in men over age 50. The cN-1A antibodies target cytosolic 5′-nucleotidase and have been reported to be highly predictive for IBM; with high specificity (87-100%) but wide ranging sensitivity estimates (33-76%).

Extended Myositis Specific Antibody Panel

Quest Diagnostics is pleased to announce the release of The Extended Myositis Specific Antibody (MSA) panel designed as an aid for the diagnosis of myopathies associated with autoantibody production. These include inflammatory myopathies (polymyositis, anti-synthetase syndrome, dermatomyositis), necrotizing myopathies, including statin associated myopathy, and inclusion body myositis.

Target Selector™ Lung NGS Panel

Target Selector Lung NGS Panel is a liquid biopsy assay designed to help physicians determine targeted therapy options for their patients with advanced NSCLC. This test is especially helpful when tissue is not available or the patient is unable to have a biopsy.

New Test Offerings

The following tests will be available through Quest Diagnostics on the dates indicated below.

Cytosolic 5’-Nucleotidase 1A (cN-1A) Antibody (IgG)

Clinical Significance

The cN-1A Ab assay is a useful aid for the diagnosis of inclusion body myositis (IBM). The analytical sensitivity of this assay is 35-70%, based on published reports (1, 2). In our validation study with 120 healthy adult subjects, 1.7% had a positive cN-1A Ab result and 6.7% had an equivocal result. However, published reports and our own internal studies suggest that patients with Sjogren’s syndrome, systemic lupus erythematosus, dermatomyositis (DM), or polymyositis (PM), are significantly more likely to have a positive cN-1A Ab result (1, 2, 3). In contrast, patients presenting clinically with IBM rarely produce autoantibodies associated with a diagnosis of DM or PM (3). Therefore, cN-1A Ab results must be interpreted in context with other details of the patient’s clinical evaluation.

Larman HB, et al. Cytosolic 5'-nucleotidase 1A autoimmunity in sporadic inclusion body myositis. Ann Neurol. 2013 Mar;73(3):408-18.
Felice KJ, et al. Neuromuscul Disord. 2018 Aug;28(8):660-664
Kramp SL, et al. Auto Immun Highlights. 2016 Dec;7(1):16. doi: 10.1007/s13317-016-0088-8

Effective Date

1/10/2022

Test Code

10266

CPT Codes

83516

Specimen Requirements

0.5 mL (0.3 mL minimum) serum

Reject Criteria

Moderate to gross hemolysis

Transport Temperature

Room temperature

Specimen Stability

Room temperature	7 days
Refrigerated	14 days
Frozen	28 days

Set-up/Analytic Time

Set up: Tues, Thurs, Sat; Report available: 2-5 days

Reference Range

Result Code	Result Name	Reference Range	Unit Of Measure
86030989	cN 1A Ab (IgG)	<15: Negative	Units
86030989	cN 1A Ab (IgG)	15-19: Borderline	Units
86030989	cN 1A Ab (IgG)	> or = 20: Positive	Units

Methodology

Enzyme Linked Immunosorbent Immunoassay

Performing Site

Quest Diagnostics Nichols Institute, San Juan Capistrano

Interface Mapping

Standard Mapping
Result Code			Result Name
86030989			Cytosolic 5' Nucleotidase 1A (cN 1A) Ab (IgG)

Extended Myositis Specific Antibody (MSA) Panel

Clinical Significance

The Extended Myositis Specific Antibody (MSA) panel is designed as an aid for the diagnosis of myopathies associated with autoantibody production. These include inflammatory myopathies (polymyositis, anti-synthetase syndrome, dermatomyositis), necrotizing myopathies, including statin associated myopathy, and inclusion body myositis.

Effective Date

1/10/2022

Test Code

10257

CPT Codes

84182(x6), 86235(x5), 83520, 83516

Specimen Requirements

1.5 mL (0.9 mL minimum) serum collected in a red-top tube (no gel)

Reject Criteria

Moderate to gross hemolysis; received room temperature; serum separator tube

Transport Temperature

Refrigerated

Specimen Stability

Room temperature	48 hours
Refrigerated and Frozen	14 days

Set-up/Analytic Time

Set up: Tues, Thurs, Sat; Report available: 2-5 days

Reference Range

See Laboratory Report

Methodology

Line Blot, Chemiluminescence, Enzyme Linked Immunosorbent Immunoassay

Performing Site

Quest Diagnostics Nichols Institute, San Juan Capistrano and Quest Diagnostics Nichols Institute, Valencia

Interface Mapping

Standard Mapping
94777 - Myositis Specific 11 Antibody Panel
Result Code			Result Name
86018952			Jo-1 Ab
86018953			PL-7 Ab
86018954			PL-12 Ab
86018955			EJ Ab
86018956			OJ Ab
86018957			SRP Ab
86018958			Mi-2 Alpha Ab
86018959			Mi-2 Beta Ab
86018960			MDA5 Ab
86018961			TIF1 Gamma Ab
86018962			NXP-2 Ab
39044 - HMGCR Ab (IgG)
Result Code			Result Name
86027073			HMGCR Ab (IgG)
10266 - Cytosolic 5’ Nucleotidase 1A (cN 1A) Antibody
Result Code			Result Name
86030989			Cytosolic 5’ Nucleotidase 1A (cN 1A) Antibody

Test Changes

The following test changes will be effective on the dates indicated below. Please note information that is changing appears in bold text in this update. Former test names and test codes have been italicized.

Myositis Specific 11 Antibody Panel

Effective Date

1/10/2022

Former Test Name

Myositis Specific 11 Antibodies Panel

Test Code

94777

Performing Site

Quest Diagnostics Nichols Institute, Valencia

Interface Mapping

Standard Mapping
Result Code			Result Name
86018952			Jo-1 Ab
86018953			Pl-7 Ab
86018954			Pl-12 Ab
86018955			EJ Ab
86018956			OJ Ab
86018957			SRP Ab
86018958			Mi-2 Alpha Ab
86018959			Mi-2 Beta Ab
86018960			MDA5 Ab
86018961			TIF1 Gamma Ab
86018962			NXP-2 Ab

Test Send Outs (Referrals)

Target Selector™ NGS Lung Panel

Revision Message!

Please note: Effective date was updated to 11/29/2021 on 11/08/2021.

Message

** This test is not available for New York patient testing **

Clinical Significance

Biocept's Target Selector™ NGS Lung Cancer Panel is intended for use on NSCLC patients for the identification and characterization of cancer biomarkers found in blood [plasma] that can inform therapy selection when biopsy is not practical or residual biopsy tissue is unavailable. These biomarkers can be found in cell-free circulating tumor DNA (ctDNA) and in tumor RNA fusion gene alterations such as ALK, ROS or RET translocations.
The Target Selector NGS Lung Cancer Panel can also be used to identify the presence of residual tumor post-surgical resection or after completion of other therapies. Residual ctDNA or ctRNA after therapy has been associated with shorter progression free survival and shorter overall survival in several published studies.

Effective Date

11/29/2021

Test Code

10449

CPT Codes

81445

Specimen Requirements

Preferred:
8 mL (4 mL minimum) whole blood collected in CEE-Sure™ BCT tube

Acceptable:
4 mL (4 mL minimum) plasma collected in CEE-Sure BCT tube

Reject Criteria

Less than 10 ng ctDNA yielded from plasma collection.
Under-filling the tube will result in improper preservative ratio and may lead to incorrect analytical results.

Instructions

Patient Preparation:
Patients may present to the PSCs with the kit for blood collection. Kits are to be delivered to the nearest Quest Diagnostics Laboratory for accessioning/processing.

Instructions:
Whole blood: Using ONLY the 4 provided CEE-Sure Blood Collection Tubes, FIRST draw 8 mL of blood into the tube labeled #1, then draw the remaining tubes. A minimum of 4 mL is needed to perform the test. Invert each tube 5 times. Label the tubes with the collection date, time of draw and include two patient identifiers.

Plasma: Collect whole blood in CEE-Sure BCT tube, spin down and transfer CEE-Sure BCT plasma to a transport tube.

** Do not ship samples the day before or after a Holiday**
** Pathologist report is required for testing **

Note:
CEE-Sure BCT is proprietary collection tube that will be stocked in a branded kit. Kit(s) need to be requested prior to sample collection.

Transport Temperature

Whole blood: Room temperature
Plasma: Frozen

Specimen Stability

Whole Blood	Room temperature and Refrigerated	8 days
Whole Blood	Frozen	Unacceptable
Plasma	Room temperature and Refrigerated	8 days
Plasma	Frozen	12 months

Set-up/Analytic Time

Set-up: Mon-Fri; Report available: 10 days from receipt

Reference Range

Result Code	Result Name	Reference Range	LOINC Code
86031241	Target Selector (TM) NGS Lung Panel	No Detected Variants

Methodology

Next-Generation Sequencing

Interface Mapping

Standard Mapping
Result Code			Result Name
86031241			Target Selector(TM) NGS Lung Panel

Anti cN 1A (NT5c1A) IBM (RDL)
Effective Date	1/10/2022	( - )
Test Code	94054	( - )
Additional Information	This test will be discontinued. The recommended alternative is test code 10266- Cytosolic 5’ Nucleotidase 1A (cN 1A) Antibody IgG	( - )