Journal Article Comparison of SARS-CoV-2 RT-PCR Ct Values across Multiple Assays with Different Targets Get access George W Pratt, George W Pratt Quest Diagnostics, North Region, Marlborough, MA, United States Address correspondence to: G.P. at Quest Diagnostics-North Region, 200 Forest St., Marlborough, MA 01752, United States. E-mail George.W.Pratt@QuestDiagnostics.com. Search for other works by this author on: Oxford Academic Google Scholar Lokinendi V Rao Lokinendi V Rao Quest Diagnostics, North Region, Marlborough, MA, United StatesUMass Chan Medical School, Pathology, Worcester, MA, United States L.V.R. at Pathology, UMass Medical School, Quest Diagnostics-North Region, 200 Forest St., Marlborough, MA 01752, United States. E-mail Lokinendi.V.Rao@QuestDiagnostics.com. Search for other works by this author on: Oxford Academic Google Scholar The Journal of Applied Laboratory Medicine, jfad057, https://doi.org/10.1093/jalm/jfad057 Published: 23 August 2023 Article history Received: 20 April 2023 Accepted: 28 July 2023 Published: 23 August 2023
Whole blood real-time polymerase chain reaction (WB-RTPCR) detection of Borrelia burgdorferi is not currently recommended for diagnosing Lyme disease. This study aims to elucidate the utility of WB-RTPCR as a diagnostic aid for early Lyme disease (ELD), defined as either positive PCR or positive immunoglobulin M with negative immunoglobulin G immunoblot.A retrospective analysis was performed on 33,199 blood specimens evaluated concurrently by WB-RTPCR and antibody-capture serology (ACEIA) methods (group A). Fifty-six pairs of specimens from a separate data set were retrospectively identified and analyzed at initial and follow-up time points to monitor for seroconversion (group B). Also, a separate data set of 2,526 specimens concurrently assessed by molecular and modified two-tiered enzyme-linked immunosorbent assay serology methods was analyzed (group C).Group A yielded 1,379 specimens consistent with ELD when tested by ACEIA and WB-RTPCR. In total, 131 (9.5% of positive results) were identified by WB-RTPCR, with negative serology. Group C identified 358 samples compatible with ELD, with 31 (8.7% of positive results) identified by RTPCR alone.When used concurrently with serologic testing, WB-RTPCR testing increases diagnostic sensitivity in cases of ELD.
Abstract Background In 2019, the CDC updated serology testing guidelines for Lyme disease diagnosis to include alternative modified two-tiered testing that replaces the western blots of standard testing with an additional ELISA. Antibody-capture serological assays have also been used as an aid for Lyme diagnosis. A panel of clinically characterized samples from the CDC was tested to compare modified two-tiered testing to the standard two-tiered algorithm and an antibody capture immunoassay. Methods A CDC panel of 92 samples comprised a range of samples including early Lyme, Lyme neuroborreliosis, Lyme arthritis, infections by other pathogens, and healthy controls. The panel was tested on a standard two-tiered platform by the CDC, the ZEUS Borrelia Test System for modified two-tiered testing, and a lab-developed antibody-capture serological assay. Sensitivity and specificity results from each assay were compared to determine significance. Results The antibody-capture assay demonstrated increased sensitivity but decreased specificity compared to the modified and standard two-tiered platforms. There was no statistical difference found between the modified and standard two-tiered platforms. Conclusions Improved sensitivity of antibody-capture when testing early Lyme disease samples is offset by decreased specificity, especially with syphilis-positive samples. Modified two-tiered testing is similar to standard two-tiered methods while also being more scalable and simpler to interpret.
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