Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

Lamb, Christopher C; Haddad, Fadi; Owens, Christopher L.; Lopez-Yunez, Alfredo M.; Carroll, Marion; Moncrieffe, Jordan

doi:10.3390/healthcare9091124

Cited by 4 publications

(4 citation statements)

References 22 publications

(25 reference statements)

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“…The CLUNGENE ® test has been previously studied, including the use of the test in the offices of general practitioners, evaluating the presence of antibodies in convalescent plasma donors, and how the test performs at a point of care facility. [18][19][20][21][22][23][24][25][26] The test employs 1 drop (; 10 mL) of whole blood added to a well followed by 2 drops of buffer. Results are available in 15 minutes.…”

Section: Methodsmentioning

confidence: 99%

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The COVID-19 Pandemic in a Hispanic Population: A Primary Care Perspective

et al. 2022

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Introduction:The COVID-19 global pandemic has affected all ethnic and minority groups although not equally. The goals of the present study are twofold: describe the diverse COVID-19-related care needs Hispanic patients presenting to a primary care facility and the symptom clusters and socioeconomic factors that may impact their wellbeing.Methods: This is a retrospective cohort of Hispanic patients in an outpatient clinic serving an urban lower socioeconomic demographic, between May 9 and July 31, 2020. COVID-19 infection was confirmed by polymerase chain reaction or rapid antibody test. Student's t-test was used for means and the chi 2 was used for comparisons of proportions.Results: A total of 6616 patients visited Alivio, 409 were triaged to a containment area, and 378 were tested for COVID-19; 230 with, 148 without symptoms. Of those tested, 161(42.6%) were positive, representing 2.4% of total patients seen. Age, temperature, and pulse rate were all significantly higher in patients with symptoms compared with those without. Symptoms were grouped into 5 clusters: constitutional, n = 143(62%), respiratory, n = 136 (59%), and somatic, n = 97(42%) were most common. No single cluster was particularly diagnostic of COVID-19, although those with symptoms in multiple clusters were more likely to test positive, P < .001. The majority worked in essential jobs, were uninsured, and had more than half had prolonged symptoms.Conclusions: Hispanic patients have diverse reasons for seeking health care and for testing in a pandemic. COVID-19 is a syndromic disease as evidenced from the clustering of symptoms. Essential workers and uninsured health status may lead to more prolonged disease course.

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Section: Methodsmentioning

confidence: 99%

“…The specificity of the assay has been reported as 100%, the sensitivity has been reported at 96.77% with no false-positive results due to infections or vaccinations unrelated to the SARS-CoV-2 virus. 27 For the present analysis, a test was considered positive if IgM, IgG, or both antibodies were present.…”

Section: Methodsmentioning

confidence: 99%

The COVID-19 Pandemic in a Hispanic Population: A Primary Care Perspective

et al. 2022

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“…The CLUNGENE ® Test was commercially available in the United States under an FDA-approved Emergency Use Authorization (EUA201121) and Europe (CE Mark reference 02PBJ267 dated 9 March 2020) [ 57 ]. The CLUNGENE ® Test has been previously studied, including the use of the test in the offices of general practitioners, evaluating the presence of antibodies in convalescent plasma donors, and how the test performs at a point-of-care facility [ 58 , 59 , 60 , 61 ]. This LFA can detect specific SARS-CoV-2 antibodies and differentiate between IgG and IgM antibody classes [ 50 , 62 ].…”

Section: Methodsmentioning

confidence: 99%

Evaluating Johnson and Johnson COVID-19 Vaccination Outcomes in a Low-Income Hispanic Population

Lamb

Owens²,

Gamboa³

et al. 2023

Vaccines

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Background: A pilot study was performed at a low-income emergency care clinic to assess the humoral immune response to the Johnson & Johnson (J&J) COVID-19 vaccine (Ad26.COV2.S) to better understand how to evaluate the COVID-19 health status of its Hispanic patient population following vaccination. Methods: This study used the Clungene® SARS-CoV-2 IgG/IgM Rapid Test Cassette to determine the presence of binding antibodies resulting from the J&J COVID-19 vaccine. The Clungene test principle is based on the receptor-binding domain (RBD) of the spike protein. Antibodies targeting the spike protein are considered an appropriate measure of humoral response from spike-based vaccines. Results: The study confirmed previous research that antibodies wane over time, and results are consistent with reported vaccine efficacy. There was a statistically significant relationship between the humoral immune response and demographic and health status variables. Conclusions: COVID-19 negative patients can be easily and efficiently monitored to determine the success and durability of COVID-19 vaccines in low-income minority populations. The use of simple low-cost spike targeted COVID-19 antibody lateral flow devices may serve as a useful adjunct to assist community-based physicians on the COVID-19 health status of its patients. Further research is needed to confirm the utility of this approach.

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“…The COVID-19 is cause by SARS-CoV-26; an enveloped RNA virus that causes respiratory, enteric, hepatic and neurological diseases 7 8. Clinical and diagnostic tools for care developed rapidly but implementation within local communities was challenging 9–13. Hospital diversions, long waits and other delays led to negative health consequences 14.…”

Section: Introductionmentioning

confidence: 99%

Use of a rapid triage assessment tool to discriminate the need for hospitalisation in patients with severe COVID-19 infection presenting to an outpatient clinic: a single-centre, prospective cohort study

Owens,

Lamb,

Sanchez

et al. 2023

BMJ Open

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ObjectivesThe WHO designated individuals with low oxygen saturation, SpO2<94%, as severe SARS-CoV2 infection (COVID-19) and recommendations to seek care in a hospital setting were advised. A rapid, office-based method to select patients with severe COVID-19 who need intensive care was necessary during the peak of the pandemic.Design, setting and participantsThis is a prospective cohort study of patients with confirmed severe COVID-19 between September 2020 and April 2021.Outcome measures and analysisOxygen saturation was obtained at rest (SpO2r), following exertion from a 20 m walk test (SpO2e), and the difference was calculated (SpO2Δ). Radiographs and laboratory values were obtained and recorded. Logistic regression models were used to determine variables associated with hospitalisation. A lung injury score was used to quantify pulmonary involvement.ResultsOut of 103 patients enrolled with severe COVID-19 infection, 19 (18.4%) were admitted to the hospital (no deaths). Patients managed as outpatients had a standard treatment protocol. The SpO2Δ and SpO2e were associated with hospitalisation (p<0.005) while SpO2r was no different between non-hospitalised and hospitalised patients (90.7%±2.7% vs 90.8%±2.3%, p=0.87). By contrast, exertional SpO2e was significantly different between non-hospitalised and hospitalised (87.3%±2.6% vs 84.4%±3.4%, p=0.0005). The mean lung injury score was 11.0±3.5 (18-point scale) and did not discriminate against those who would need hospitalisation. Lower lung fields were significantly more involved than the upper (p<0.0001). All patients had elevated biomarkers of inflammation, C reactive protein (CRP) median 82.5 IQR (43–128.6) mg/L and evidence of elevated liver enzymes. A logistic regression model was constructed including SpO2Δ, CRP and alanine aminotransferase to predict hospitalisation. Only SpO2Δ was significant, p=0.012, 95% CI (1.128 to 2.704) and correctly classified 85.71% of patients who could remain at home or would need to receive treatment in the hospital.ConclusionAn office-based, 20 m walk test can help diverge patients with severe COVID-19 who need escalated care. Further, an aggressive standardised treatment protocol can be used to successfully manage patients outside of hospitals despite having severe COVID-19.

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Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

Cited by 4 publications

References 22 publications

The COVID-19 Pandemic in a Hispanic Population: A Primary Care Perspective

The COVID-19 Pandemic in a Hispanic Population: A Primary Care Perspective

Evaluating Johnson and Johnson COVID-19 Vaccination Outcomes in a Low-Income Hispanic Population

Use of a rapid triage assessment tool to discriminate the need for hospitalisation in patients with severe COVID-19 infection presenting to an outpatient clinic: a single-centre, prospective cohort study

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