Research & Diagnostic Laboratories, Inc. News and Information

Jump to Story
Abbott PRISM Installed and Validated
HCVAB and HBsAg PRISM Assay Validation Study Summaries
PRISM HCVAB Assay Validation
PRISM HBsAg Assay Validation


Abbott PRISM Installed and Validated - Back to Top
April 11, 2008.

On April 09, 2008 RDL completed installation and validation of the Abbott PRISM system in its laboratory at 4402 Terrace View Road, Louisville, TN 37777. On April 10, 2008, RDL completed the validation of HCVAB and HB testing on the PRISM. On April 11, 2008 RDL began runs of record for HBsAg and HCVAB on the RPSIM System.

This is an important step to be taken by RDL. The purchase and implementation of the PRISM is in response to changes in the industry that required this decision.

First, a Guidance from the FDA entitled:

Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes.

In this document, the FDA states “This guidance represent the Food and Drug Administration’s (FDA’s) current thinking on minimum sensitivity standards for such HBsAg assays, as they relate to testing “to reduce adequately and appropriately the risk of transmission of communicable disease” under 21 CFR 610.40(b) (see Section III).

The Blood Products Advisory Committee (BPAC) recommendation from March 15, 2001(http://www.fda.gov/ohrms/dockets/ac/01docsbc.htm) was taken into consideration by the FDA.

Consequently the FDA has recommended that assays used under 21 CFR 610.40(b) to test whole blood and blood components, including Source Plasma and Source Leukocyte donations have a capability of detecting at least 0.05ng HBsAg/mL.

HBsAg assays that do not have this capability should not be used to test Whole Blood and blood components, including Source Plasma and Source Leukocyte donations, because FDA believes that tests that are incapable of identifying HBsAg at these limits are not adequate to reduce the risk of communicable disease transmission. If more HBsAg assays demonstrate greater capability to detect HBsAgat even lower levels, we will reconsider this recommendation.

Second, Abbott’s response to this Guidance:

Abbott was forced to remove their HBsAg EIA assay kit from the market effective June 30, 2008. Therefore, any test for HBsAg done after June 30, 2008, must be performed with an assay with a sensitivity of ≤0.5ng of HBsAg/mL. Abbott’s option is the PRISM system.

We agree that a few HBsAg positive donors may be detected by the lower sensitivity of the PRISM System. In fact, during our correlation studies, we detected two HBsAg Commander System Negative specimens that were reactive on the PRISM system.

To better serve you, we are pleased to have this instrument in our laboratory and to have several capable technologists trained and operating this system on two shifts.

For your review, we have included a copy of the HCVAB and HBsAg validation studies under another news and information heading below.

If you have any questions please call our Laboratory Director, Dr. Ernest W. Fuson at 865-977-5598.

HCVAB and HBsAg PRISM Assay Validation Study Summaries - Back to Top

The correlation/validation studies for HCVAB and HBsAg are presented on the following pages.

The raw data and documentation for the correlation/validation studies are available for review by all auditors visiting our facility at 4402 Terrace View Road, Louisville, TN 37777.

The equipment installation qualification, operational qualification, performance qualification and calibration studies are available for review by all auditors visiting our facility at 4402 Terrace View Road, Louisville, TN 37777.

PRISM HCVAB Assay Validation - Back to Top

141 specimens were tested on the Commander (Reference Method) and the PRISM (New Method). The attached chart lists all specimens tested and their results in each assay procedure. Additionally, all data from both instruments systems is attached for review.

PRISM HCVAB Assay Validation

The chart below demonstrates the concordance between the Commander System and the PRISM. Four specimen outcomes are possible and are depicted: Positive Commander and Positive PRISM (concordant results), Negative Commander and Negative PRISM (concordant results), Positive Commander and Negative PRISM (discordant results), and Negative Commander and Positive PRISM (discordant results). The goal is 95% concordance.

Negative Commander & Negative PRISM 122 specimens	Positive Commander & Negative PRISM 0 specimens
Negative Commander & Positive PRISM 0 specimens	Positive Commander & Positive PRISM 19 specimens

There was 100% concordance between the negative specimens (122 of 122 concordant) and 100% concordance between the Positive specimens (19 of 19).

Review and Approval:

Ernest W. Fuson, PhD - Date 04-11-08
Laboratory Director

PRISM HBsAg Assay Validation - Back to Top

146 specimens were tested on the Commander (Reference Method) and the PRISM (New Method) The attached table lists all specimens tested and their results in each assay procedure.

The chart below demonstrates the concordance between the Commander System and the PRISM. Four specimen outcomes are possible and are depicted: Positive Commander and Positive PRISM (concordant results), Negative Commander and Negative PRISM (concordant results), Positive Commander and Negative PRISM (discordant results), and Negative Commander and Positive PRISM (discordant results). The goal is >95% concordance.

Negative Commander & Negative PRISM 127 specimens	Positive Commander & Negative PRISM 0 specimens
Negative Commander & Positive PRISM 2 specimens	Positive Commander & Positive PRISM 17 specimens

There was 98% concordance between the negative specimens (127 of 129) and 100% concordance between the Positive specimens (17 of 17).

Review and Approval:

Ernest W. Fuson, PhD - Date 04-11-08
Laboratory Director