Early Sjogren's Syndrome Profile

Test code

93748

CPT code(s)*

0472U

In-home collection may be available in your area for purchase through Quest Mobile.

Clinical significance

Early Sjogren's Syndrome Profile - Sjogren's syndrome (SS) is a systemic autoimmune disease in which loss of salivary gland and lachrymal gland function is associated with hypergammaglobulinemia, autoantibody production, mild kidney and lung disease and eventually lymphoma. SS involves dry eyes and dry mouth without systemic features that may be either primary or secondary to another autoimmune disease, such as SLE. Patients with SS and picked up at a late stage in their disease, after the salivary glands and lachrymal glands are already destroyed, because they are asymptomatic until that time. At this point, only symptomatic treatment can be offered for…

Test resources

None found for this test
Please visit our Clinical Education Center to stay informed on any future publications, webinars, or other education opportunities.

Details

Test details

Includes

Carbonic Anhydrase VI (CA VI) IgG Antibodies, Carbonic Anhydrase VI (CA VI) IgA Antibodies, Carbonic Anhydrase VI (CA VI) IgM Antibodies
Parotid Specific Protein (PSP) IgG Antibodies, Parotid Specific Protein (PSP) IgA Antibodies, Parotid Specific Protein (PSP) IgM Antibodies
Salivary Protein 1 (SP-1) IgG Antibodies, Salivary Protein 1 (SP-1) IgA Antibodies, Salivary Protein 1 (SP-1) IgM Antibodies

Methodology

Enzyme Linked Immunosorbent Assay (ELISA)

Assay category

This test has been developed and performance parameters have been validated by IMMCO Diagnostics, Inc. This test has not been approved by the U.S. Food and Drug Administration (FDA); however, US FDA approval is not required for clinical use. It is not intended that clinical diagnosis and patient management decisions be made using these results alone.
This test has been validated using serum samples. The manufacturer has not determined the efficacy of this test when performed on CSF, plasma, joint, or pleural fluid specimens. The performance characteristics of this test were determined by IMMCO Diagnostics, Inc.

Alternative name(s)

Sjogrens

Specimen requirements
Patient preparation	None Specified
Preferred specimen(s)	2 mL serum
Minimum volume	0.5 mL
Collection instructions	Specimen need not be refrigerated or frozen. Collect 2-3 mL of blood in a red-top or Serum separator tube (SST). If possible, separate serum from clot and place into white tube provided with Immco Diagnostics' collection kits. If separation facilities are not available, the blood can be sent in the tube used for collection.
Transport container	Transport tube
Transport temperature	Room temperature
Specimen stability	Room temperature: 5 days Refrigerated: 5 days Frozen: 1 year
Reject criteria	Gross hemolysis • Grossly lipemic • Grossly icteric • Specimens other than serum

Reference range(s)

See Laboratory Report

LOINC® codes

The Result and LOINC® information listed below should not be used for electronic interface maintenance with Quest Diagnostics. Please contact the Quest Diagnostics Connectivity Help Desk for more information at 800-697-9302.

NOTE: The codes listed in the table are not orderable Test Codes

Result code	Result name	LOINC code	Component name
86015038	SALIVARY PROTEIN 1 (SP 1) IGG ANTIBODIES*	77210-3	Salivary gland protein 1 Ab.IgG
86015039	SALIVARY PROTEIN 1 (SP 1) IGA ANTIBODIES*	77208-7	Salivary gland protein 1 Ab.IgA
86015040	SALIVARY PROTEIN 1 (SP 1) IGM ANTIBODIES*	77209-5	Salivary gland protein 1 Ab.IgM
86015041	CARBONIC ANHYDRASE VI (CA VI) IGG ANTIBODIES*	77212-9	Carbonic anhydrase 6 Ab.IgG
86015042	CARBONIC ANHYDRASE VI (CA VI) IGA ANTIBODIES*	77211-1	Carbonic anhydrase 6 Ab.IgA
86015043	CARBONIC ANHYDRASE VI (CA VI) IGM ANTIBODIES*	77213-7	Carbonic anhydrase 6 Ab.IgM
86015044	PAROTID SPECIFIC PROTEIN (PSP) IGG ANTIBODIES*	77215-2	Parotid secretory protein Ab.IgG
86015045	PAROTID SPECIFIC PROTEIN (PSP) IGA ANTIBODIES*	77214-5	Parotid secretory protein Ab.IgA
86015046	PAROTID SPECIFIC PROTEIN (PSP) IGM ANTIBODIES*	77216-0	Parotid secretory protein Ab.IgM
86015047	COMMENTS	8251-1	Service comment

Performing lab & setup schedule

Performing laboratory

Immco Diagnostics, Inc

10 Earhart Drive, Suite 100

Williamsville, NY 14221

Setup schedule

Set up: Mon; Report available: 21 days

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.