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23120 HIV-1,2 Ab/Ag by EIA with Confirmation

HIV-1,2 Ab/Ag by EIA with Confirmation
Test Code: HIVR
Synonyms/Keywords
HIV-1 Antibody, HIV-2 Antibody, HIV-1 p24 Antigen, HIV-1, HIV-2
Test Components
Single qualitative result for reactivity of HIV-1,2 Antibody/Antigen, with automatic reflex to confirmatory testing.
Useful For
Used for the detection of antibodies to the human Immunodeficiency virus type 1, including Group O, and/or type 2 in serum.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ EDTA Plasma EDTA Pink Top Tube (PTT) EDTA Lavender Top Tube (LTT)
 1 mL​ 0.5 mL​ ​

​

​​Serum (Screen only, see Note below)
​​Red Top Tube (RTT) or Serum Separator Tube (SST)
​1 mL
​0.5 mL
​
Collection Processing Instructions
·       Centrifugation and refrigerated/frozen storage must occur within 24 hours of collection for either sample type.
·       EDTA plasma samples may be centrifuged immediately after collection.
·       If serum is inadvertently collected (see note below), complete clot formation should take place before centrifugation.
·       After centrifugation, physically separate plasma/serum from the red cells and send aliquot for analysis.
·       Specimens must be free of particulate matter including fibrin.
 
            Note: Serum can only be used for initial HIV testing, it cannot be used for Mayo HVDIP confirmation  
                     testing of REACTIVE samples.
 
·       Specimens are stable for 24 hours at room temperature, this includes pre- & post- centrifugation time, separated or unseparated from red cells.
·       Store plasma/serum specimens at 2–8°C if not tested within 24 hours of collection.  Separated specimens are stable for 14 days at 2–8ºC.
·       For longer storage, plasma/serum may be frozen for 8 months at -20ºC or colder. Samples may undergo up to 5 freeze/thaw cycles.
·       Frozen samples must be completely thawed, thoroughly mixed, and centrifuged before analysis.
·       For U-have testing, specimens are stable in primary tubes up to 14 days at 2–8°C (this includes plasma stored on packed red cells, serum stored on the clot, and specimens processed and stored in gel barrier blood collection tubes).
 
            If REACTIVE, Mayo Medical Labs will require an additional 1 mL of EDTA plasma.
Specimen Stability Information
Specimen Type Temperature Time
Plasma / Serum
 Ambient​ 24 hours​
Refrigerate​ 14 days​
Frozen​ (-20C) 8 months
Rejection Criteria
​Grossly hemolyzed
​Grossly icteric
​Specimens containing precipitate
​Cadaver specimens
​Heat-inactivated specimens
​Body fluids other than serum
Samples stored at room temperature for longer than 24 hours,
this includes pre- and post- centrifugation time. 
Samples stored for longer than 14 days at 2–8°C​
Specimens with obvious microbial contamination.​
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Marshfield Monday through Sunday​ 2 hours Sandwich Chemiluminometric Immunoassay/Siemens Centaur
Test Information

The consenting process changed in July 2010; therefore consent form is not required.

This test uses a 3-tier algorithm: HIV Algorithm 

Western blot analysis is no longer recommended nor used to confirm HIV EIA antibody-positive results. The 3-tier algorithm described above will yield unambiguous results for HIV status in virtually all cases. Tier 1 (HIV-1/2 Ag/Ab combination immunoassay) will be performed at Marshfield; tier 2 (HIV-1/HIV-2 Ab differentiation immunoassay) will be automatically reflexed and sent to an appropriate testing laboratory; tier 3, the HIV-1 Viral Load assay (test code: HIVPCR) will be recommended in consultation with the ordering provider. Note that the vast majority of samples will yield a definitive result of HIV status by the end of tier 2.
Reference Range Information
Performing Location Reference Range
Marshfield​ ​ Expected Value: Non-Reactive
​Results are reported as "Non-reactive" or "Reactive​"
Interpretation

NON-REACTIVE: This screening test found no evidence of HIV-1 or HIV-2 antibodies or HIV-1 p24 Antigen.

REACTIVE: This screening test is REACTIVE for HIV-1 and/or HIV-2 antibodies or HIV-1 p24 Antigen. An HIV-1 and HIV-2 Antibody Confirmation and Differentiation assay is automatically ordered.

Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
87389 ​ ​ ​1 HIV-1 Ag(s), with HIV-1 and HIV-2 Abs, single result ​
Synonyms/Keywords
HIV-1 Antibody, HIV-2 Antibody, HIV-1 p24 Antigen, HIV-1, HIV-2
Test Components
Single qualitative result for reactivity of HIV-1,2 Antibody/Antigen, with automatic reflex to confirmatory testing.
Ordering Applications
Ordering Application Description
​Centricity ​HIV-1,2 Ab/Ag EIA w/Confirm
​Cerner ​HIV 1,2 Antibody/Antigen w/Confirmation (Common)
​Clinical Order Manager ​​HIV-1,2 Ab/Ag EIA w/Confirm
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ EDTA Plasma EDTA Pink Top Tube (PTT) EDTA Lavender Top Tube (LTT)
 1 mL​ 0.5 mL​ ​

​

​​Serum (Screen only, see Note below)
​​Red Top Tube (RTT) or Serum Separator Tube (SST)
​1 mL
​0.5 mL
​
Collection Processing
·       Centrifugation and refrigerated/frozen storage must occur within 24 hours of collection for either sample type.
·       EDTA plasma samples may be centrifuged immediately after collection.
·       If serum is inadvertently collected (see note below), complete clot formation should take place before centrifugation.
·       After centrifugation, physically separate plasma/serum from the red cells and send aliquot for analysis.
·       Specimens must be free of particulate matter including fibrin.
 
            Note: Serum can only be used for initial HIV testing, it cannot be used for Mayo HVDIP confirmation  
                     testing of REACTIVE samples.
 
·       Specimens are stable for 24 hours at room temperature, this includes pre- & post- centrifugation time, separated or unseparated from red cells.
·       Store plasma/serum specimens at 2–8°C if not tested within 24 hours of collection.  Separated specimens are stable for 14 days at 2–8ºC.
·       For longer storage, plasma/serum may be frozen for 8 months at -20ºC or colder. Samples may undergo up to 5 freeze/thaw cycles.
·       Frozen samples must be completely thawed, thoroughly mixed, and centrifuged before analysis.
·       For U-have testing, specimens are stable in primary tubes up to 14 days at 2–8°C (this includes plasma stored on packed red cells, serum stored on the clot, and specimens processed and stored in gel barrier blood collection tubes).
 
            If REACTIVE, Mayo Medical Labs will require an additional 1 mL of EDTA plasma.
Specimen Stability Information
Specimen Type Temperature Time
Plasma / Serum
 Ambient​ 24 hours​
Refrigerate​ 14 days​
Frozen​ (-20C) 8 months
Rejection Criteria
​Grossly hemolyzed
​Grossly icteric
​Specimens containing precipitate
​Cadaver specimens
​Heat-inactivated specimens
​Body fluids other than serum
Samples stored at room temperature for longer than 24 hours,
this includes pre- and post- centrifugation time. 
Samples stored for longer than 14 days at 2–8°C​
Specimens with obvious microbial contamination.​
Useful For
Used for the detection of antibodies to the human Immunodeficiency virus type 1, including Group O, and/or type 2 in serum.
Test Components
Single qualitative result for reactivity of HIV-1,2 Antibody/Antigen, with automatic reflex to confirmatory testing.
Reference Range Information
Performing Location Reference Range
Marshfield​ ​ Expected Value: Non-Reactive
​Results are reported as "Non-reactive" or "Reactive​"
Interpretation

NON-REACTIVE: This screening test found no evidence of HIV-1 or HIV-2 antibodies or HIV-1 p24 Antigen.

REACTIVE: This screening test is REACTIVE for HIV-1 and/or HIV-2 antibodies or HIV-1 p24 Antigen. An HIV-1 and HIV-2 Antibody Confirmation and Differentiation assay is automatically ordered.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Marshfield Monday through Sunday​ 2 hours Sandwich Chemiluminometric Immunoassay/Siemens Centaur
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
87389 ​ ​ ​1 HIV-1 Ag(s), with HIV-1 and HIV-2 Abs, single result ​
For most current information refer to the Marshfield Laboratory online reference manual.