Diagnostic accuracy of a rapid E1-antigen test for chikungunya virus infection in a reference setting

Huits, Ralph; Okabayashi, Tamaki; Cnops, Lieselotte; Barbé, Barbara; Berg, Riemsdijk van den; Bartholomeeusen, Koen; Ariën, Kevin K.; Jacobs, Jan; Bottieau, Emmanuel; Nakayama, Emi E.; Shioda, Tatsuo; Esbroeck, Marjan Van

doi:10.1016/j.cmi.2017.06.004

Cited by 28 publications

(31 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Rapid diagnostic tests, that meet the ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and delivered on location) are urgently needed [ 80 ]. CHIKV-antigen detection tests are being developed, but unsatisfactory diagnostic performance across different genotypes does not permit commercialization yet [ 81 , 82 ].…”

Section: Discussionmentioning

confidence: 99%

Chikungunya virus infection in Aruba: Diagnosis, clinical features and predictors of post-chikungunya chronic polyarthralgia

et al. 2018

View full text Add to dashboard Cite

BackgroundChikungunya virus (CHIKV) emerged in Aruba for the first time in 2014. We studied the clinical presentation of acute CHIKV infection and the contribution of serologic and molecular assays to its diagnosis. In a cohort of confirmed CHIKV cases, we analysed the frequency, duration and predictors of post-chikungunya chronic polyarthralgia (pCHIK-CPA), defined as joint pains lasting longer than 6 weeks or longer than 1 year.MethodologyPatient sera obtained within 10 days of symptom onset were tested for CHIKV, using an indirect immunofluorescence test for the detection of CHIKV-specific Immunoglobulin M (IgM) and post-hoc, by reverse-transcription polymerase chain reaction (RT-PCR). CHIKV was isolated from selected samples and genotyped. For confirmed CHIKV cases, clinical data from chart review were complemented by a Telephone survey, conducted 18–24 months after diagnosis. When joint pain was reported, the duration, presence of inflammatory signs, type and number of joints affected, were recorded. Joint involvement was scored according to the 2010 ‘American College of Rheumatology/ European League Against Rheumatism’ criteria for seronegative rheumatoid arthritis (ACR-score). Risk factors for pCHIK-CPA were identified by logistic regression.Principal findingsAcute CHIKV infection was diagnosed in 269 of 498 sera, by detection of IgM (n = 105), by RT-PCR (n = 59), or by both methods (n = 105). Asian genotype was confirmed in 7 samples. Clinical data were complete for 171 of 248 (69.0%) patients, aged 15 years or older (median 49.4 [35.0–59.6]). The female-to-male ratio was 2.2. The main acute symptoms were arthralgia (94%), fever (85%), myalgia (85%), headache (73%) and rash (63%). In patients with arthralgia (n = 160), pCHIK-CPA longer than 6 weeks was reported by 44% and longer than 1 year by 26% of cases. Inflammatory signs, stiffness, edema and redness were frequent (71%, 39% and 21%, respectively). Joints involved were knees (66%), ankles (50%), fingers (52%), feet (46%), shoulders (36%), elbows (34%), wrists (35%), hips (31%), toes (28.1%) and spine (28.1%). Independent predictors of pCHIK-CPA longer than 1 year were female gender (OR 5.9, 95%-CI [2.1–19.6]); high ACR-score (7.4, [2.7–23.3]), and detection of CHIKV-RNA in serum beyond 7 days of symptom onset (6.4, [1.4–34.1].ConclusionsWe identified 269 CHIKV patients after the first outbreak of Asian genotype CHIKV in Aruba in 2014–2015. RT-PCR yielded 59 (28%) additional CHIKV diagnoses compared to IgM antibody detection alone. Arthralgia, fever and skin rash were the dominant acute phase symptoms. pCHIK-CPA longer than 1 year affected 26% of cases and was predicted by female gender, high ACR-score and CHIKV-RNA detection beyond 7 days of symptom onset.

show abstract

Section: Discussionmentioning

confidence: 99%

Chikungunya virus infection in Aruba: Diagnosis, clinical features and predictors of post-chikungunya chronic polyarthralgia

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Antigen capture assays are also in development, though these are used less commonly than antigen-based methods for DENV. An immunochromatographic assay using monoclonal antibodies against the E1 protein was developed to detect CHIKV antigen in serum (169), but this test was found to be sensitive only for the ECSA lineage (89%) and not for the Asian lineage (33%) (170). Another antigen capture ELISA reported 96% concordance with real-time RT-PCR results for acute-phase samples from 200 subjects in India (146), and a test for whole CHIKV antigen in acute-phase samples had an overall agreement of 94% with RT-PCR (171).…”

Section: Chikv Diagnosticsmentioning

confidence: 99%

Beyond Fever and Pain: Diagnostic Methods for Chikungunya Virus

2019

View full text Add to dashboard Cite

Chikungunya virus (CHIKV) is an alphavirus that is primarily transmitted by Aedes species mosquitoes. Though reports of an illness consistent with chikungunya date back over 200 years, CHIKV only gained worldwide attention during a massive pandemic that began in East Africa in 2004. Chikungunya, the clinical illness caused by CHIKV, is characterized by a rapid onset of high fever and debilitating joint pain, though in practice, etiologic confirmation of CHIKV requires the availability and use of specific laboratory diagnostics. Similar to infections caused by other arboviruses, CHIKV infections are most commonly detected with a combination of molecular and serological methods, though cell culture and antigen detection are reported. This review provides an overview of available CHIKV diagnostics and highlights aspects of basic virology and epidemiology that pertain to viral detection. Although the number of chikungunya cases has decreased since 2014, CHIKV has become endemic in countries across the tropics and will continue to cause sporadic outbreaks in naive individuals. Consistent access to accurate diagnostics is needed to detect individual cases and initiate timely responses to new outbreaks.

show abstract

“…Although the test was in 96% concordance with RT-PCR, the samples were collected from CHIKV patients in India, thus limiting the performance of the test to the detection of the CHIKV Asian lineage [30]. An immunochromatographic assay was reported by Okabayashi et al (2015) in which monoclonal antibodies against the E1 protein were developed and used to detect the CHIKV antigen [31][32][33]. However, this test targets only one envelope protein and displays a limit of detection of 1 × 105 PFU/mL.…”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Rapid Lateral Flow E1/E2-Antigen Test and ELISA in Patients Infected with Emerging Asian Strain of Chikungunya Virus in the Americas

Reddy

Bosch

Salcedo³

et al. 2020

Viruses

View full text Add to dashboard Cite

Since its 2013 emergence in the Americas, Chikungunya virus (CHIKV) has posed a serious threat to public health. Early and accurate diagnosis of the disease, though currently lacking in clinics, is integral to enable timely care and epidemiological response. We developed a dual detection system: a CHIKV antigen E1/E2-based enzyme-linked immunosorbent assay (ELISA) and a lateral flow test using high-affinity anti-CHIKV antibodies. The ELISA was validated with 100 PCR-tested acute Chikungunya fever samples from Honduras. The assay had an overall sensitivity and specificity of 51% and 96.67%, respectively, with accuracy reaching 95.45% sensitivity and 92.03% specificity at a cycle threshold (Ct) cutoff of 22. As the Ct value decreased from 35 to 22, the ELISA sensitivity increased. We then developed and validated two lateral flow tests using independent antibody pairs. The sensitivity and specificity reached 100% for both lateral flow tests using 39 samples from Colombia and Honduras at Ct cutoffs of 20 and 27, respectively. For both lateral flow tests, sensitivity decreased as the Ct increased after 27. Because CHIKV E1/E2 are exposed in the virion surfaces in serum during the acute infection phase, these sensitive and specific assays demonstrate opportunities for early detection of this emerging human pathogen.

show abstract

Diagnostic accuracy of a rapid E1-antigen test for chikungunya virus infection in a reference setting

Cited by 28 publications

References 11 publications

Chikungunya virus infection in Aruba: Diagnosis, clinical features and predictors of post-chikungunya chronic polyarthralgia

Chikungunya virus infection in Aruba: Diagnosis, clinical features and predictors of post-chikungunya chronic polyarthralgia

Beyond Fever and Pain: Diagnostic Methods for Chikungunya Virus

Development and Validation of a Rapid Lateral Flow E1/E2-Antigen Test and ELISA in Patients Infected with Emerging Asian Strain of Chikungunya Virus in the Americas

Contact Info

Product

Resources

About