Per changes in DLS labs, following changes will be implemented on 12/06/2014.
This will update prenatal flowsheet as well.
Removed from Centricity
1. HIV-1 Ab, Western Blot
2. HIV 1/2 Ab
3. HIV 1/2 Reflex to Western Blot
4. HIV 1/2 Ab, Prenatal
HIV lab options in Centricity
1. T-Helper-Inducer Cell (CD2,T4) - CPT86359/DLS971
2. HIV Viral Load
3. HIV-1/2 Ag/Ab with Reflex
For more information click on 'read more'.
This will update prenatal flowsheet as well.
Removed from Centricity
1. HIV-1 Ab, Western Blot
2. HIV 1/2 Ab
3. HIV 1/2 Reflex to Western Blot
4. HIV 1/2 Ab, Prenatal
HIV lab options in Centricity
1. T-Helper-Inducer Cell (CD2,T4) - CPT86359/DLS971
2. HIV Viral Load
3. HIV-1/2 Ag/Ab with Reflex
For more information click on 'read more'.
Clinical Background
The 4th generation HIV-1/2 Antigen/Antibody test reveals a reduced time-to-detection compared to the 3rd generation HIV-1/HIV-2 EIA. This reduced time-to-detection for the HIV “window period” is in the range of 0 to 20 days. This 4th generation HIV-1/2 test shows reactivity for both HIV-1 (Groups M and O) and HIV-2 positive specimens and for all known HIV groups and variants.
Test Performance
The specificity of the GS HIV Combo Ag/Ab EIA in low risk populations was shown to be 99.87% with a 95% CI of 99.76 – 99.93%.
The use of the Multispot HIV-1/HIV-2 Rapid Test as the HIV-1/HIV-2 antibody differentiation assay in a CDC diagnostic testing algorithm was compared to test results from an HIV-1 Western blot, an HIV-1 qualitative RNA assay, or both. Some specimens were also tested with an HIV-2 EIA or HIV-2 qualitative RNA assay.The Multispot sensitivity observed in this study was 99.52% with a 95% confidence internal of 98.26 - 99.62% and the observed specificity was 99.03% with a 95% confidence interval of 97.54 - 99.61%.
Test Intended Use and Limitations
· The GS HIV Combo Ag/Ab EIA test is intended for use as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection.
· The GS HIV Combo Ag/Ab EIA test may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (i.e., children as young as 2 years of age).
· Nonreactive results can occur if the quantity of marker present in the sample is below the detection limits of the assay, or if the marker that is detected is not present during the stage of disease in which a sample is collected.
Methodology
This GS HIV Combo Ag/Ab EIA is an enzyme
immunoassay used for the simultaneous qualitative detection of Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum or plasma.
The Multispot HIV-1/HIV-2 Rapid Test is a single use qualitative immunoassay used to detect and
differentiate circulating antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1, HIV-2).
Test Ordering Information
Test Name
Unit Code
4th Generation HIV-1/2 Ag/Ab With Reflex to Multispot
56880
Specimen Collection and Transport
Specimen Type: Serum Separator Tube (SST®) – 2 ml serum (1ml serum as minimal volume) or EDTA plasma
Other specimen types: Sodium citrate, sodium heparin
Specimen Stability
Ambient Stability: 48 hours at room temperature
Refrigerated (2-8°C): 7 days
Frozen Stability (-20°C or lower): 30 days (-20°C) or indefinite (-70°C) with 4 or less freeze-thaw cycles
Local Transport: Room temperature
Reference Range(s)
Negative for HIV-1 and HIV-2 antibodies and p24
CPT Code
87389
HIV-1 antigen with HIV-1 and HIV-2 antibodies (GS HIV Combo Ag/Ab EIA)
86701
HIV-1 antibody (Multispot HIV-1)
86702
HIV-2 antibody (Multispot HIV-2)
References
1. June 21, 2013. Detection of Acute HIV Infection in Two Evaluations of a New HIV Diagnostic Testing Algorithm. United States, 2011–2013 MMWR Morb Mortal Wkly Rep 62 (24) pp. 489-494.
2. Quick Reference Guide-Labortory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, 2014.
3. BIO-RAD GS HIV Combo Ag/Ab EIA test kit package insert. July 2011.
4. Multispot HIV-1/HIV-2 Rapid Test kit package insert. March 2013.
Figure 1 HIV diagnostic testing algorithm using the Multispot Rapid HIV-1/HIV-2 Differentiation Assay with the new HIV diagnostic testing algorithm from CDC (Bold indicates the results for the final report). If clinically indicated and if the immunoassay test result is discordant or the result is negative for suspected high risk individuals, supplemental HIV testing such as HIV-1 nucleic acid amplification may be ordered as follow-up HIV testing in 2 to 4 weeks as support for acute HIV infection.
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Notes
1. (Pos) indicates a reactive test and (Neg) indicates nonreactive test result.
2. If the test result is negative for suspected high risk individuals or discordant due to a possible false-positive result, the following comment will appear on the report:
“If clinically indicated and if the immunoassay test result is discordant or the result is negative for suspected high risk individuals, supplemental HIV testing such as HIV-1 nucleic acid amplification should be considered as followup testing in 2-4 weeks.”