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Test ID: FNMEN
Neisseria Meningitidis IgG Vaccine Response

Secondary ID A test code used for billing and in test definitions created prior to November 2011

91669

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Method Name A short description of the method used to perform the test

Multi-Analyte Immunodetection (MAID)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

N. meningititdis IgG Vacc Response

Aliases Lists additional common names for a test, as an aid in searching

Meningococcal IgG Vaccine Response FORWARD
N. Meningitidis IgG Vaccine Response FORWARD

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Draw blood in a plain, red-top tube(s). Spin down and send 0.5 mL

serum refrigerated.

 

Note: Serum gel tube is acceptable, but must pour off into a

plastic vial.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.3 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Specimens other than

Serum

Anticoagulants other than

NA

Hemolysis

NA

Thawing

Warm OK; Cold OK

Lipemia

NA

Icteric

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)30 days
 Frozen 14 days
 Ambient 5 days

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Reference Ranges (pre-vaccination):

 

Serogroup A                                       <4.0 ug/mL

 

Serogroup C                                       <5.0 ug/mL

 

Serogroup Y                                       <4.0 ug/mL

 

Serogroup W-135                             <3.0 ug/mL

 

This assay measures serum IgG antibodies recognizing

polysaccharide antigens from the four Neisseria meningitidis

serogroups included in the licensed meningococcal vaccine.

The meningococcal vaccine response is best evaluated by

testing pre-vaccination and post-vaccination samples in

parallel. A two-fold or greater increase for at least two sero-

groups is expected when comparing post-vaccination to

pre-vaccination results. N. meningitidis IgG levels peak

approximately one month post-vaccination, but decline

markedly by two years.

 

Test Performed By:  Focus Diagnostics, Inc.

                                        5785 Corporate Ave.

                                        Cypress, CA  90630-4714

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Wednesday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 - 8 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 - 12 days

Performing Laboratory Location The location of the laboratory that performs the test

Focus Diagnositics, Inc.

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86317/x4

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
Z0726Serogroup AIn Process
Z0532Serogroup CIn Process
Z0533Serogroup YIn Process
Z0534Serogroup W-135In Process