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Gold Standard Diagnostics Launches AIX1000 2.1® with Extra High Titer RPR Testing
Amzeal News/10615604
Gold Standard Diagnostics receives FDA clearance for AIX1000® 2.1-- now with extra high titer capabilites.
DAVIS, Calif. - Amzeal -- Gold Standard Diagnostics Launches AIX1000 2.1® with Extra High Titer RPR Testing and Enhanced Workflow Features
Gold Standard Diagnostics is proud to announce the release of AIX1000® Version 2.1, a major upgrade to its flagship RPR automation platform. This release introduces extra high titer capability, now supporting screens and titers up to 1:2048, a breakthrough in syphilis detection and treatment monitoring—especially for late-stage and Neurosyphilis cases.
The expanded titer range empowers laboratories to more accurately track antibody levels over time, improving clinical decision-making and supporting public health initiatives focused on syphilis control and eradication.
This AIX1000® 2.1 upgrade is the first and only FDA cleared automated test system to meet the 2024 CDC Laboratory Recommendations for Syphilis Testing "Recommendation for endpoint titers. Endpoint titers (the highest dilution yielding a reactive result) should be determined and clearly reported when testing serum with nontreponemal (lipoidal antigen) assays that detect antibodies to lipoidal antigens (i.e., rapid plasma reagin and Venereal Disease Research Laboratory).1"
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"Extra high titer testing is vital for improving detection of late-stage or Neurosyphilis cases, tracking the effectiveness of syphilis treatment over time, and supporting public health need for endpoint titers" said Sean Hoesterey, Vice President of Commercial Operations, at Gold Standard Diagnostics.
In addition to the enhanced titer range, AIX1000® 2.1 delivers a suite of workflow and data management improvements designed to streamline operations and improve clarity:
The AIX1000® 2.1 software is fully compatible with:
Gold Standard Diagnostics was the first FDA cleared automated RPR testing platform in 2015 and continues to lead innovation in automated RPR testing, delivering precision, speed, and reliability to clinical laboratories worldwide.
More on Amzeal News
For more information, email Gsd.info@us.goldstandarddiagnostics.com or contact your GSD representative.
For media inquiries, please contact:
Sarah Siegel
Marketing Communications Specialist
sarah.siegel@us.goldstandarddiagnostics.com
(707) 239-2863
1Papp J. R. et al. 2024. CDC Laboratory Recommendations for Syphilis Testing, United States, 2024. MMWR Recomm Rep., 73(No. RR-1):1–32. DOI: http://dx.doi.org/10.15585/mmwr.rr7301a1 (https://nam10.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdx.doi.org%2F10.15585%2Fmmwr.rr7301a1&data=05%7C02%7C%7C146e2af518cb40e2b79108de0c1bf10a%7C19e5846425f4437da9d21182f30f78eb%7C0%7C0%7C638961511313225122%7CUnknown%7CTWFpbGZsb3d8eyJFbX...).
Gold Standard Diagnostics is proud to announce the release of AIX1000® Version 2.1, a major upgrade to its flagship RPR automation platform. This release introduces extra high titer capability, now supporting screens and titers up to 1:2048, a breakthrough in syphilis detection and treatment monitoring—especially for late-stage and Neurosyphilis cases.
The expanded titer range empowers laboratories to more accurately track antibody levels over time, improving clinical decision-making and supporting public health initiatives focused on syphilis control and eradication.
This AIX1000® 2.1 upgrade is the first and only FDA cleared automated test system to meet the 2024 CDC Laboratory Recommendations for Syphilis Testing "Recommendation for endpoint titers. Endpoint titers (the highest dilution yielding a reactive result) should be determined and clearly reported when testing serum with nontreponemal (lipoidal antigen) assays that detect antibodies to lipoidal antigens (i.e., rapid plasma reagin and Venereal Disease Research Laboratory).1"
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"Extra high titer testing is vital for improving detection of late-stage or Neurosyphilis cases, tracking the effectiveness of syphilis treatment over time, and supporting public health need for endpoint titers" said Sean Hoesterey, Vice President of Commercial Operations, at Gold Standard Diagnostics.
In addition to the enhanced titer range, AIX1000® 2.1 delivers a suite of workflow and data management improvements designed to streamline operations and improve clarity:
- Reflex Runs After Worklist Completion
- Automatic Next Actions
- Improved LIS Communication – Easier for LIS systems to interpret run data
- Enhanced Data Analysis
- Faster Backup and Restore
- Bleach Maintenance Support – Compatible with the GSD Bleach (Cat # SHW-20)
- Optional Text and Email Notifications for Errors
The AIX1000® 2.1 software is fully compatible with:
- Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System (Cat # GSD01-1600)
- GSD Bleach (Cat # SHW-20)
- GSD RPR Diluent (Cat # GSD01-1600-DIL)
Gold Standard Diagnostics was the first FDA cleared automated RPR testing platform in 2015 and continues to lead innovation in automated RPR testing, delivering precision, speed, and reliability to clinical laboratories worldwide.
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For more information, email Gsd.info@us.goldstandarddiagnostics.com or contact your GSD representative.
For media inquiries, please contact:
Sarah Siegel
Marketing Communications Specialist
sarah.siegel@us.goldstandarddiagnostics.com
(707) 239-2863
1Papp J. R. et al. 2024. CDC Laboratory Recommendations for Syphilis Testing, United States, 2024. MMWR Recomm Rep., 73(No. RR-1):1–32. DOI: http://dx.doi.org/10.15585/mmwr.rr7301a1 (https://nam10.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdx.doi.org%2F10.15585%2Fmmwr.rr7301a1&data=05%7C02%7C%7C146e2af518cb40e2b79108de0c1bf10a%7C19e5846425f4437da9d21182f30f78eb%7C0%7C0%7C638961511313225122%7CUnknown%7CTWFpbGZsb3d8eyJFbX...).
Source: Gold Standard Diagnostics, LLC
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