Development and Implementation of Autoverification Rules for ELISA Results of HBV Serological Markers

Abstract

Autoverification is a process of using computer-based rules to verify clinical laboratory test results without manual review. But to date, there are few published articles on the use of autoverification over the course of years in a clinical laboratory. In our study, we firstly described the development and implementation of autoverification rules for enzyme-linked immunosorbent assay (ELISA) results of hepatitis B virus (HBV) serological markers in a clinical immunology laboratory. We designed the autoverification rules for HBV by using Boolean logic on five clinically used serological markers in accordance with the framework of AUTO-10A, issued by the American Clinical Laboratory Standards Institute in 2006. The rules were written into the laboratory information system (LIS) and installed in the computer, so we could use the LIS to screen the test results. If the results passed the autoverification rules, they could be sent to doctors immediately. To evaluate the autoverification rules, we applied the real-time data of 11,585 patients with the autoverification rules. The autoverification rate of the five HBV serological markers was 79.5%. Furthermore, the turnaround time (TAT) was reduced by 38% (78 minutes vs. 126 minutes). The error rate was nearly eliminated. These results show that using LIS with autoverification rules can shorten TAT, enhance efficiency, and reduce manual review errors.

Development and Implementation of a Coagulation Factor Testing Method Utilizing Autoverification in a High-volume Clinical Reference Laboratory Environment

“…Although other studies have been reported on autoverification practices with respect to other commonly run tests in the clinical laboratory, including hepatitis B virus ELISAs,[7] thyroid function profiles,[8] as well as for clinical chemistry panels,[910] we are only aware of two other papers discussing autoverification for coagulation applications. [1112] In the papers focusing on coagulation applications, autoverification practices are featured with regard to routine coagulation parameters, including prothrombin time (PT), aPTT, and fibrinogen[12] and PT, aPTT, fibrinogen, D-dimer, and AT.…”

Attention to the problem of the inaccurate testing caused by virus mutation strains in clinical laboratory settings

“…At present, the most common methods of virus testing in clinical laboratory settings include as following: serological diagnosis based on antigen or antibody such as ELISA [2][3][4], and nucleic acid test methods including PCR [5], RT-PCR [6,7], real-time PCR [8][9][10][11][12][13], and molecular hybridization [14][15][16], etc. However, there may be different test results when different kits or test methods were used.…”

Molecular Aggregation in Immune System Activation Studied by Dynamic Light Scattering

“…The most common method of determining the concentration of immune complexes is the ELISA test. However, it demands a set of enzymes, markers, and reagents so it is currently impossible to implement it for regular screening of the 2 of 13 population [6,7]. The opposite disadvantages belong to hemolytic tests, used to assess the activity of the immune system in general.…”