Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease

Wormser, Gary P.; Schriefer, Martin E.; Agüero-Rosenfeld, Maria E.; Levin, Andrew; Steere, Allen C.; Nadelman, Robert B.; Nowakowski, John; Marques, Adriana; Johnson, Barbara J. B.; Dumler, J. Stephen

doi:10.1016/j.diagmicrobio.2012.09.003

Cited by 140 publications

(128 citation statements)

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“…However, our study was inadequately powered to show a sensitivity benefit of the C6 EIA in early Lyme disease, because only 14% of the serum samples from patients with Lyme disease came from those with solitary EM lesions. In keeping with findings from previous studies [4,7,9,16], we found that the C6 EIA alone was less specific than standard 2-tiered testing. The specificity of a 2-tiered strategy with C6 EIA followed by supplemental immunoblot did not differ from that of standard WCS EIA based 2-tiered testing.…”

Section: Discussionsupporting

confidence: 90%

“…Several previous studies have evaluated the performance of the C6 EIA in adults [4,8,9,14,15]. In the largest study to date, the C6 EIA was evaluated as a stand-alone test in serum samples from 528 well-characterized patients with Lyme disease as well as from healthy blood donors [9].…”

Section: Discussionmentioning

confidence: 99%

“…In the largest study to date, the C6 EIA was evaluated as a stand-alone test in serum samples from 528 well-characterized patients with Lyme disease as well as from healthy blood donors [9]. The C6 EIA had superior sensitivity in patients with early disease (a single EM lesion) when compared with standard 2-tiered testing (58% vs 27%, respectively; P < .001), whereas sensitivity was similar for the 2 approaches in patients with later stages of disease [9]. Overall sensitivity in our study did not differ significantly between any of the strategies evaluated.…”

Section: Discussionmentioning

confidence: 99%

“…Based on previous local experience, we assumed that approximately 20% of collected specimens would be from patients with confirmed Lyme disease, of whom approximately 25% would have EM. To demonstrate a 30% difference in sensitivity between C6 EIA and standard 2-tiered testing for the diagnosis of early Lyme disease [9] with an α of .05 and power of 80%, we estimated that 840 serum samples would be needed from patients undergoing evaluation for Lyme disease.…”

Section: Sample Sizementioning

confidence: 99%

“…The C6 Lyme EIA measures antibody reactivity to a synthetic peptide corresponding to the sixth invariable region of VlsE, a highly conserved surface protein of the causative Borrelia burgdorferi bacterium [5]. The currently available commercial C6 EIA can be run in house in as little as 1 hour [6] and is cleared by the Food and Drug Administration as a first-tier test to be followed by a supplemental immunoblot [4,[7][8][9]. In adults, the C6 EIA alone has demonstrated superior sensitivity and comparable specificity compared with standard 2-tiered serology [4,[7][8][9].…”

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confidence: 99%

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Evaluation of the C6 Lyme Enzyme Immunoassay for the Diagnosis of Lyme Disease in Children and Adolescents

Lipsett¹,

Branda

McAdam

et al. 2016

Clin Infect Dis.

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5Pediatric Physicians' Organization at Children's, Brookline, MassachusettsBackground. The commercially-available C6 Lyme enzyme immunoassay (EIA) has been approved to replace the standard whole-cell sonicate EIA as a first-tier test for the diagnosis of Lyme disease and has been suggested as a stand-alone diagnostic. However, the C6 EIA has not been extensively studied in pediatric patients undergoing evaluation for Lyme disease.Methods. We collected discarded serum samples from children and adolescents (aged ≤21 years) undergoing conventional 2-tiered testing for Lyme disease at a single hospital-based clinical laboratory located in an area endemic for Lyme disease. We performed a C6 EIA on all collected specimens, followed by a supplemental immunoblot if the C6 EIA result was positive but the wholecell sonicate EIA result was negative. We defined a case of Lyme disease as either a clinician-diagnosed erythema migrans lesion or a positive standard 2-tiered serologic result in a patient with symptoms compatible with Lyme disease. We then compared the performance of the C6 EIA alone and as a first-tier test followed by immunoblot, with that of standard 2-tiered serology for the diagnosis of Lyme disease.Results. Of the 944 specimens collected, 114 (12%) were from patients with Lyme disease. The C6 EIA alone had sensitivity similar to that of standard 2-tiered testing (79.8% vs 81.6% for standard 2-tiered testing; P = .71) with slightly lower specificity (94.2% vs 98.8% 2; P < .002). Addition of a supplemental immunoblot improved the specificity of the C6 EIA to 98.6%.Conclusions. For children and adolescents undergoing evaluation for Lyme disease, the C6 EIA could guide initial clinical decision making, although a supplemental immunoblot should still be performed.

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Section: Discussionsupporting

confidence: 90%