Finger Prick Blood Test Approved for Herpes Simplex 1
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By LabMedica International staff writers Posted on 04 Aug 2015 |
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Image: Photomicrograph of the viral cytopathic effect of herpes simplex virus (HSV) showing multi-nucleation and ground glass chromatin (Photo courtesy of Nephron).
Image: Transmission electron micrograph (TEM) of numerous herpes simplex virions, members of the Herpesviridae virus family (Photo courtesy of Dr. Fred Murphy and Sylvia Whitfield).
A blood test and test system for the herpes simplex 1 virus (HSV-1) immunoglobulin G (IgG), has now received a Clinical Laboratory Improvement Amendments (CLIA) Waiver, permitting its use in locations outside of traditional clinical laboratories.
The system has built in fault-tolerance to deal with conditions that otherwise would impact results and performance and mitigate errors associated with otherwise unpredictable environments and therefore can be performed at least as well in the field with non-laboratory personnel as by trained operators in a traditional laboratory setting.
The US Food and Drug Administration (FDA; Silver Springs, MD, USA) concluded that the test and technology is eligible for waiver under CLIA. The waiver means FDA determined the test and technology is reliable and accurate and can be used in a broader set of locations outside of a traditional CLIA certified laboratory, including Wellness Centers. This is the first HSV test and test system to receive a CLIA waiver.
The test and test system for the herpes simplex 1 virus IgG (HSV-1) is manufactured by Theranos (Palo Alto, CA, USA) who provided study data from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using only a finger stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA cleared, commercially available reference method.
Theranos’ HSV-1 studies included matrix comparison studies across 69 Theranos devices. The use of such a large number of devices in the studies is unusual as such studies are often run on a single or small number of devices. The larger number of devices allows for comprehensive characterization of variation across devices, which can be a source of variance in data across laboratories. Theranos’ HSV-1 clinical studies also included sensitivity and specificity studies with hundreds of human samples, both capillary and venous, Centers for Disease Control and Prevention (CDC; Atlanta.GA, USA) panel testing, which demonstrated 100% agreement with the results provided by CDC, low-prevalence population tests, and other studies.
Related Links:
US Food and Drug Administration
Theranos
Centers for Disease Control and Prevention
The system has built in fault-tolerance to deal with conditions that otherwise would impact results and performance and mitigate errors associated with otherwise unpredictable environments and therefore can be performed at least as well in the field with non-laboratory personnel as by trained operators in a traditional laboratory setting.
The US Food and Drug Administration (FDA; Silver Springs, MD, USA) concluded that the test and technology is eligible for waiver under CLIA. The waiver means FDA determined the test and technology is reliable and accurate and can be used in a broader set of locations outside of a traditional CLIA certified laboratory, including Wellness Centers. This is the first HSV test and test system to receive a CLIA waiver.
The test and test system for the herpes simplex 1 virus IgG (HSV-1) is manufactured by Theranos (Palo Alto, CA, USA) who provided study data from 818 subjects of varying age and ethnicity, demonstrating that its system could be run accurately using only a finger stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA cleared, commercially available reference method.
Theranos’ HSV-1 studies included matrix comparison studies across 69 Theranos devices. The use of such a large number of devices in the studies is unusual as such studies are often run on a single or small number of devices. The larger number of devices allows for comprehensive characterization of variation across devices, which can be a source of variance in data across laboratories. Theranos’ HSV-1 clinical studies also included sensitivity and specificity studies with hundreds of human samples, both capillary and venous, Centers for Disease Control and Prevention (CDC; Atlanta.GA, USA) panel testing, which demonstrated 100% agreement with the results provided by CDC, low-prevalence population tests, and other studies.
Related Links:
US Food and Drug Administration
Theranos
Centers for Disease Control and Prevention
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