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Sedia Biosciences Corporation
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  5. Sedia - HIV-1 Limiting Antigen ...

Sedia - HIV-1 Limiting Antigen (LAg)-Avidity EIA

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An in vitro single well quantitative limiting antigen avidity enzyme immunoassay for distinguishing recent HIV-1 infections from those which are long-term. Intended for use with liquid serum or plasma specimens.

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Gold Standard for Incidence

Independent evaluation by CEPHIA showed lowest false recency rate of any HIV incidence assay evaluated.*

*Kassanjee R, Pilcher C, Keating S, et al. on behalf of the Consortium for the Evaluation and Performance of HIV Incidence Assays (CEPHIA), Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository. AIDS 2014 Oct 23; 28(16) 2439-2449. 
Designed for Surveillance

Can be used to estimate HIV-1 incidence in a population, monitor and evaluate HIV intervention programs, and recognize those high-incidence populations. Ensures prevention research, vaccine trials, and resources are most appropriately utilized.

Assay Time: 2-4 Hours

Processing Temperature: 15° to 37°C (59° to 98.6°F)

Storage Temperature: Refrigerator Pack: +2° to 8°C (35.6° to 46.4°F); Freezer Pack: -25° to -10°C (-13° to +14°F)

Specimen Type: Human serum or plasma

Specimen Volume: 5 µL

Custom Antigen: Custom, multi-clade CDC “rIDR-M” HIV-1 gp41 antigen that provides for reduced HIV-1 subtype bias

Mean Duration of Recent Infection: Approximately 130 days*

False Recency Rate: Less than 1%**

U.S. CDC Qualified: Each lot is performance tested by the U.S. Centers for Disease Control prior to market release

For Research Use Only: Not for use in diagnostic procedures, RUO products are not to be used for diagnostic purposes, patient management, clinical purposes, or for investigational use within the U.S.

HIV Status Requirement: Intended for use only with specimens previously diagnosed as HIV-1 positive

The assay incorporates a custom multi-clade CDC “rIDR-M” HIV-1 gp41 antigen that provides for reduced HIV-1 subtype bias. Mean duration of recent infection approximately 130 days.*

*Duong YT, Kassanjee R, Welte A, et al. Recalibration of the Limiting Antigen Avidity EIA to determine mean duration of recent infection in divergent HIV-1 subtypes. PLoS ONE 2015, 10(2)e0114947.

Each Sedia® HIV-1 LAg-Avidity EIA lot is performance tested by both Sedia’s Quality Control Department and by the U.S. Centers for Disease Control prior to market release.

Certification of CDC testing can be provided upon request.

**Parekh B, Duong Y, Mavengere Y, et al. Performance of new LAg-Avidity EIA to measure HIV-1 incidence estimates and avidity maturation studies. PLoS ONE 2012, 7(3):e33328.