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

Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two studies were performed by using the CLUNGENE® Rapid Test. (1) An expanded Point-of-Care (POC) study at two clinical sites was conducted to evaluate 99 clinical subjects: 62 positive subjects and 37 negative subjects were compared to RT-PCR, PPA, and NPA (95% CI). Sensitivity was calculated from blood-collection time following symptom onset. (2) A cross-reactivity study was performed to determine the potential for false-positive results from other common infections. Results: The specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4–100.0%). The sensitivity of subjects with confirmed positive COVID-19 by RT-PCR was 96.77% (95% CI, 88.98–99.11%). In the cross-reactivity study, there were no false-positive results due to past infections or vaccinations unrelated to the SARS-CoV-2 virus. Conclusion: There is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. The CLUNGENE® Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.

Download Full-text

Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy215 ◽

2018 ◽

Vol 5 (10) ◽

Cited By ~ 3

Author(s):

Carlos A Gomez ◽

Laura N Budvytyte ◽

Cindy Press ◽

Lily Zhou ◽

Rima McLeod ◽

...

Keyword(s):

Diagnostic Accuracy ◽

False Positive ◽

Point Of Care ◽

Congenital Toxoplasmosis ◽

Rapid Test ◽

The United States ◽

Cross Reactivity ◽

Chronic Infections ◽

Toxoplasma Infection ◽

Screening Programs

Abstract Background The cost of conventional serological testing for toxoplasmosis discourages universal adoption of prenatal monthly screening programs to prevent congenital toxoplasmosis. Point-of-care (POC) technology may constitute a cost-effective approach. Methods We evaluated the diagnostic accuracy of 3 Toxoplasma POC tests against gold-standard testing performed at Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL). The POC tests included the following: Toxo IgG/IgM Rapid Test (Biopanda) and the OnSite Toxo IgG/IgM Combo-Rapid-test that detect IgG and IgM separately, and the Toxoplasma ICT-IgG-IgM-bk (LDBIO) that detects either or both immunoglobulin IgG/IgM in combination. Samples were selected from PAMF-TSL biobank (n = 210) and Centers for Disease Control and Prevention Toxoplasma 1998 Human Serum Panel (n = 100). Based on PAMF-TSL testing, Toxoplasma-infection status was classified in 4 categories: acute infections (n = 85), chronic infections (n = 85), false-positive Toxoplasma IgM (n = 60), and seronegative (n = 80). The POC testing was performed in duplicate following manufacturer’s instructions by investigators blinded to PAMF-TSL results. Sensitivity and specificity were calculated. Results A total of 1860 POC tests were performed. For detection of Toxoplasma IgG, sensitivity was 100% (170 of 170; 95% confidence interval [CI], 97.8%–100%) for all 3 POC kits; specificity was also comparable at 96.3% (77 of 80; 95% CI, 89.5%–98.9%), 97.5% (78 of 80; 95% CI, 91.3%–99.6%), and 98.8% (79 of 80; 95% CI, 93.2%–99.9%). However, sensitivity for detection of Toxoplasma IgM varied significantly across POC tests: Biopanda, 62.2% (51 of 82; 95% CI, 51.4%–71.9%); OnSite, 28% (23 of 82; 95% CI, 19.5%–38.6%); and LDBIO combined IgG/IgM, 100% (82 of 82; 95% CI, 95.5%–100%). Diagnostic accuracy was significantly higher for the LDBIO POC kit. The POC kits did not exhibit cross-reactivity for false-positive Toxoplasma-IgM sera. Conclusions The 3 evaluated POC kits revealed optimal sensitivity for Toxoplasma-IgG antibodies. The LDBIO-POC test exhibited 100% sensitivity for the combined detection of IgG/IgM in acute and chronic Toxoplasma infection. Biopanda and Onsite POC tests exhibited poor sensitivity for Toxoplasma-IgM detection.

Download Full-text

Perbandingan Metode RT-PCR dan Tes Rapid Antibodi untuk Deteksi COVID-19

Jurnal Kesehatan Manarang ◽

10.33490/jkm.v6ikhusus.317 ◽

2020 ◽

Vol 6 (Khusus) ◽

pp. 47

Author(s):

Anita Suswanti Agustina ◽

Rizana Fajrunni'mah

Keyword(s):

Rapid Test ◽

Antibody Test ◽

Rt Pcr ◽

Literature Study ◽

Antibody Testing ◽

Advantages And Disadvantages ◽

Pcr Method ◽

Risk Of Exposure ◽

Antibody Tests ◽

Rapid Antibody

COVID-19 is caused by SARS-CoV-2, which can spread rapidly from human to human. There are several laboratory tests to detect COVID-19, including the Reverse Transcription-Polymerase Chain Reaction (RT-PCR) method and a rapid test antibody test to detect antibody reactions to SARS-CoV-2. Both methods have advantages and disadvantages of each, while the literature study comparing the two methods is currently limited. The type of research used is library research. Research materials have been collected from various journals, books, and guidelines, in line with the research topic, to obtain 24 library sources. The results of the literature study indicate that the target genes that can be used to detect COVID-19 RT-PCR methods include the N, E, RdRp, and ORF1a/b genes. The sensitivity of rapid antibody tests is known to range from 68−89%, while the specificity of rapid antibody tests ranges from 91−100%. RT-PCR has the advantage of being able to detect low-concentration antigens, but RT-PCR has weaknesses such as requiring expensive equipment and inspection fees, specially trained laboratory personnel, long working time, and high risk of exposure. Rapid antibody testing has advantages, including ease of sampling, lower testing costs, reduced risk of exposure to officers, does not require special equipment and space, but has the potential for cross-reactivity with other coronaviruses. Both the RT-PCR method and the rapid antibody test have their advantages and disadvantages, but rapid antibody testing with RT-PCR can improve the diagnosis of COVID-19. The results of this literature study are expected to be continued as a basis for further research on RT-PCR examination and antibody rapid test for COVID-19 detection in Indonesia, accompanied by information on onset time and time-testing with a large sample of research.

Download Full-text

Point-of-care serological assays for SARS-CoV-2 in a UK hospital population: potential for enhanced case finding

10.21203/rs.3.pex-930/v1 ◽

2020 ◽

Author(s):

Scott Pallett ◽

Aatish Patel ◽

Gary Davies ◽

Luke Moore

Keyword(s):

Test Performance ◽

Serological Test ◽

Point Of Care ◽

Rapid Test ◽

Antibody Test ◽

Preliminary Evaluation ◽

Hospital Inpatient ◽

Case Identification ◽

Global Pandemic ◽

Population Potential

Abstract Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic, causing over 3,600,000 reported cases and 250,000 deaths worldwide.1 Case identification has predominantly been made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. Where a plurality of point-of-care (POC) SARS-CoV-2 antibody test kits have become available, we will therefore aim to evaluate a range of kits against the current available gold-standard diagnostic test of PCR in an initial, exploratory study. We will then proceed to carry out testing with 200 hospital inpatients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette against PCR in order to undergo a preliminary evaluation of POC serological test performance characteristics within a hospital inpatient cohort.

Download Full-text

High-throughput immunoassays for SARS-CoV-2, considerable differences in performance when comparing three methods

10.1101/2020.05.22.20106294 ◽

2020 ◽

Cited By ~ 1

Author(s):

Oskar Ekelund ◽

Kim Ekblom ◽

Sofia Somajo ◽

Johanna Pattison-Granberg ◽

Karl Olsson ◽

...

Keyword(s):

High Throughput ◽

Rapid Test ◽

Performance Criteria ◽

Clinical Use ◽

Rt Pcr ◽

Regulatory Authorities ◽

Flow Test ◽

Lateral Flow Test ◽

High Level ◽

Positive Results

Background: The recently launched high-throughput assays for the detection of antibodies against SARS-CoV-2 may change the managing strategies for the COVID-19 pandemic. This study aimed at investigating the performance of three high-throughput assays and one rapid lateral flow test relative to the recommended criteria defined by regulatory authorities. Methods: A total of 133 samples, including 100 pre-pandemic samples, 20 samples from SARS-CoV-2 RT-PCR positive individuals, and 13 potentially cross-reactive samples were analysed with SARS-CoV-2 IgG (Abbott), Elecsys Anti-SARS-CoV-2 (Roche), LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology Co). Results: All assays performed with a high level of specificity; however, only Abbott reached 100% (95% CI 96.3-100). The pre-pandemic samples analysed with Roche, DiaSorin and Dynamiker Biotechnology resulted in two to three false-positive results per method (specificity 96.9-98.0%). Sensitivity differed more between the assays, Roche exhibiting the highest sensitivity (100%, CI 83.9-100). The corresponding figures for Abbott, DiaSorin and Dynamiker Biotechnology were 85.0%, 77.8% and 75.0%, respectively. Conclusions: The results of the evaluated SARS-CoV-2 assays vary considerably as well as their ability to fulfil the performance criteria proposed by regulatory authorities. Introduction into clinical use in low-prevalent settings, should therefore, be made with caution.

Download Full-text

Low Rate of False-Positive Results with Use of A Rapid HIV Test

Infection Control and Hospital Epidemiology ◽

10.1086/502061 ◽

2002 ◽

Vol 23 (6) ◽

pp. 335-337 ◽

Cited By ~ 10

Author(s):

Cassandra D. Salgado ◽

Heidi L. Flanagan ◽

Doris M. Haverstick ◽

Barry M. Farr

Keyword(s):

Enzyme Immunoassay ◽

False Positive ◽

Diagnostic System ◽

Rapid Test ◽

Occupational Exposures ◽

High Rate ◽

Negative Results ◽

Hiv Test ◽

Rapid Hiv Test ◽

Positive Results

Background:Occupational exposure to human immunodeficiency virus (HIV) is an important threat to healthcare workers. Centers for Disease Control and Prevention guidelines recommend prompt institution of prophylaxis. This requires (1) immediate prophylaxis after exposure, pending test results that may take more than 24 hours in many hospitals; or (2) performance of a rapid test. The Single Use Diagnostic System (SUDS)® HIV-1 Test is used to screen rapidly for antibodies to HIV type 1 in plasma or serum, with a reported sensitivity of more than 99.9%. We used this test from January 1999 until September 2000, when it was withdrawn from the market following reports claiming a high rate of false-positive results.Methods:We reviewed the results of postexposure HIV testing during 21 months.Results:A total of 884 SUDS tests were performed on source patients after occupational exposures (883 negative results, 1 reactive result). The results of repeat SUDS testing on the reactive specimen were also reactive, but the results of enzyme immunoassay and Western blot testing were negative. A new specimen from the same patient showed a negative result on SUDS testing. This suggested a specificity of 99.9%. In the 4 months after SUDS testing was suspended, there was 1 false-positive result on enzyme immunoassay for 1 of 132 source patients (presumed specificity, 99.2%).Conclusion:Use of the SUDS test facilitated rapid and accurate evaluation of source specimens, obviating unnecessary prophylaxis.

Download Full-text

Point-Of-Care Clinical Evaluation of the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test cassette with the Cobas® Roche RT-PCR platform in patients with or without Covid-19

LymphoSign Journal ◽

10.14785/lymphosign-2021-0017 ◽

2021 ◽

Author(s):

Fadi Haddad ◽

Christopher C Lamb ◽

Ravina Kullar ◽

George Sakoulas

Keyword(s):

Symptom Onset ◽

Serological Test ◽

Point Of Care ◽

Diagnostic Testing ◽

Rapid Test ◽

Lateral Flow ◽

Added Value ◽

Lateral Flow Immunoassay ◽

Rt Pcr ◽

Past Infection

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.

Download Full-text

Potential Antigenic Cross-reactivity Between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Dengue Viruses

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1207 ◽

2020 ◽

Cited By ~ 9

Author(s):

Yaniv Lustig ◽

Shlomit Keler ◽

Rachel Kolodny ◽

Nir Ben-Tal ◽

Danit Atias-Varon ◽

...

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Envelope Protein ◽

False Positive ◽

In Silico ◽

Rapid Test ◽

Cross Reactivity ◽

Lateral Flow ◽

Immunoglobulin M ◽

Enzyme Linked Immunosorbent Assay ◽

Elisa Testing

Abstract Background Coronavirus disease 2019 (COVID-19) and dengue fever are difficult to distinguish given shared clinical and laboratory features. Failing to consider COVID-19 due to false-positive dengue serology can have serious implications. We aimed to assess this possible cross-reactivity. Methods We analyzed clinical data and serum samples from 55 individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To assess dengue serology status, we used dengue-specific antibodies by means of lateral-flow rapid test, as well as enzyme-linked immunosorbent assay (ELISA). Additionally, we tested SARS-CoV-2 serology status in patients with dengue and performed in-silico protein structural analysis to identify epitope similarities. Results Using the dengue lateral-flow rapid test we detected 12 positive cases out of the 55 (21.8%) COVID-19 patients versus zero positive cases in a control group of 70 healthy individuals (P = 2.5E−5). This includes 9 cases of positive immunoglobulin M (IgM), 2 cases of positive immunoglobulin G (IgG), and 1 case of positive IgM as well as IgG antibodies. ELISA testing for dengue was positive in 2 additional subjects using envelope protein directed antibodies. Out of 95 samples obtained from patients diagnosed with dengue before September 2019, SARS-CoV-2 serology targeting the S protein was positive/equivocal in 21 (22%) (16 IgA, 5 IgG) versus 4 positives/equivocal in 102 controls (4%) (P = 1.6E−4). Subsequent in-silico analysis revealed possible similarities between SARS-CoV-2 epitopes in the HR2 domain of the spike protein and the dengue envelope protein. Conclusions Our findings support possible cross-reactivity between dengue virus and SARS-CoV-2, which can lead to false-positive dengue serology among COVID-19 patients and vice versa. This can have serious consequences for both patient care and public health.

Download Full-text

Is There a Role of Using a Rapid Finger Prick Antibody Test in Screening for Celiac Disease in Children?

Gastroenterology Research and Practice ◽

10.1155/2019/4504679 ◽

2019 ◽

Vol 2019 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Kristina Baraba Dekanić ◽

Ivona Butorac Ahel ◽

Lucija Ružman ◽

Jasmina Dolinšek ◽

Jernej Dolinšek ◽

...

Keyword(s):

Celiac Disease ◽

Point Of Care ◽

Tissue Transglutaminase ◽

Rapid Test ◽

Antibody Test ◽

First Grade ◽

Iga Deficiency ◽

Iga Antibodies ◽

Point Of Care Tests

Introduction. Celiac disease (CD) is an autoimmune disease triggered by gluten in genetically predisposed individuals. Despite the increasing prevalence of CD, many patients remain undiagnosed. Standard serology tests are expensive and invasive, so several point-of-care tests (POC) for CD have been developed. We aimed to determine the prevalence of CD in first-grade pupils in Primorje-Gorski Kotar County, Croatia, using a POC test. Methods. A Biocard celiac test that detects IgA antibodies to tissue transglutaminase in whole blood was used to screen for celiac disease in healthy first-grade children born in 2011 and 2012 who consumed gluten without restrictions. Results. 1478 children were tested, and none of them were tested positive with a rapid test. In 10 children (0,6%), IgA deficiency has been suspected; only 4 of them agreed to be tested further for total IgA, anti-tTG, and anti-DGP antibodies. IgA deficiency was confirmed in 3 patients, and in all 4 children, CD has been excluded. Conclusion. Our results have not confirmed the usefulness of the POC test in screening the general population of first-grade schoolchildren. Further research is needed to establish the true epidemiology of CD in Primorje-Gorski Kotar County and to confirm the value of the rapid test in comparison with standard antibody CD testing.

Download Full-text