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Test ID: FBORE
Bordetella pertussis Antibodies, IgG and IgM by ELISA with Reflex to Immunoblot

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

No

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
FBAGIB. pertussis Ab, IgG ImmunoblotNoNo
FBAMIB. pertussis Ab, IgM ImmunoblotNoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

If Bordetella pertussis Antibody, IgG by ELISA is 2.5 U/mL or greater, then B. pertussis Ab, IgG Immunoblot testing will be performed at an additional charge.

If Bordetella pertussis Antibody IgM by ELISA is 1.2 U/mL or greater, then B. pertussis Ab, IgM Immunoblot testing will be performed at an additional charge.

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

Semi-Quantitative Enzyme-Linked Immunosorbent Assay/
Qualitative Immunoblot

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

B. pertussis Abs, IgG, IgM w/Reflex

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

BORDPAN 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). (Serum gel tube is acceptable.) Separate from cells within 2 hours of collection. Send 1 mL of serum refrigerate in 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

Hemolysis:

NA

Thawing:

Warm reject; Cold OK

Lipemia:

Mild OK; Gross OK

Icterus:

NA

Other:

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)14 days
 Frozen 365 days
 Ambient 48 hours

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.

B. pertussis Ab, IgG by ELISA   <=2.4 U/mL        

B. pertussis Ab, IgM by ELISA   <=1.1 U/mL

 

Recommend that treatment decisions be based on the result of the B.pertussis IgM immunoblot instead of the ELISA test. B.pertussis IgM test by ELISA may produce false-positive results.

 

Test Performed By:    ARUP Laboratories

                                500 Chipeta Way

                                Salt Lake City, UT   84108

Interpretation Provides information to assist in interpretation of the test results

Detectable levels of IgG antibodies to B. pertussis may be

seen in the serum of vaccinated individuals of all ages, in

early infancy as the result of placental transfer, and in

the convalescent phase of a recent infection. IgG antibodies

can only be used to diagnose active infection when paired

sera are available and a rise in antibody level can be

demonstrated. A significant rise may not always be demon-

strated as peak levels of IgG may be reached before the

first sample is collected. Therefore, IgA and IgM antibody

levels should be measured to diagnose active disease.

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.

Tuesday

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 -11 days

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

ARUP Laboratories

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 determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

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.

86615/x2

86615 (per immunoblot if appropriate)

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
Z2614B. pertussis Ab, IgGIn Process
Z2615B. pertussis Ab, IgMIn Process