scholarly journals The Risk of False-Positive Serological Results for Paratuberculosis in Mycobacterium bovis-Infected Cattle

Pathogens ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1054
Author(s):  
Anna Didkowska ◽  
Monika Krajewska-Wędzina ◽  
Daniel Klich ◽  
Kinga Prolejko ◽  
Blanka Orłowska ◽  
...  
Keyword(s):  
Mycobacterium Bovis ◽  
False Positive ◽  
Significant Risk ◽  
Elisa Test ◽  
Cross Reactivity ◽  
Economic Losses ◽  
Infected Cattle ◽  
Increased Risk ◽  
Gross Lesions ◽  
Positive Results

Both bovine tuberculosis (BTB) and paratuberculosis (paraTB) continue to cause significant economic losses in cattle breeding; in addition, their etiological agents have zoonotic potential. Although the diagnostics of both diseases are still being improved, problems still remain, such as the potential for cross-reactivity to the antigens used in tests. The aim of the present study was to confirm whether animals known to harbor Mycobacterium bovis antibodies are at increased risk of yielding positive results in paraTB serotesting and, additionally, to verify the accuracy of three commonly used methods for confirming M. bovis infection: ELISA, the tuberculin skin test (TST), and the presence of gross lesions. Material was collected from 98 dairy cattle suspected of BTB due to TST-positive results. During postmortem examination, gross lesions were assessed visually. Blood, lymph nodes, and TB-suspected organs were collected. Serum was obtained from the collected blood and tested serologically for TB and paraTB. The tissues underwent standard microbiological testing for M. tuberculosis complex. Among the 98 TST-positive individuals, tuberculous gross lesions were detected in 57 (58.1%), MTBC were isolated in 83 (84.7%), and the ELISA test was positive for 21 (21.4%). None of the lesions characteristic for paraTB were detected. The chance of obtaining a positive TB result by ELISA was seven times higher using the ELISA-paraTB method; hence, there is a significant risk of obtaining false-positive serological results for paraTB in M. bovis-infected cattle. However, the hypothesis that infection of M. bovis or prior TST performance may have boosted the host immune response and therefore increased the sensitivity of the paraTB-ELISA cannot be excluded.

scholarly journals False-Positive Results of Plasma PCR for Cytomegalovirus DNA due to Delayed Sample Preparation

2000 ◽  
Vol 38 (9) ◽  
pp. 3249-3253 ◽  
Author(s):  
Peter Schäfer ◽  
Werner Tenschert ◽  
Matthias Schröter ◽  
Kai Gutensohn ◽  
Rainer Laufs
Keyword(s):  
False Positive ◽  
Room Temperature ◽  
Significant Risk ◽  
Median Number ◽  
Plasma Samples ◽  
Cmv Infection ◽  
Latently Infected ◽  
Positive Results ◽  
Native Plasma ◽  
Cmv Dnaemia

Positive results by cytomegalovirus (CMV) PCR of plasma are considered predictive of active CMV infection in kidney allograft recipients. To assess whether contamination with leukocyte-derived CMV DNA can distort the results, aliquots of whole-blood samples from 60 CMV immunoglobulin G-positive patients with leukocyte CMV DNAemia were stored for up to 24 h at room temperature (RT) and at 4°C before plasma preparation. Native and ultrafiltered plasma samples were tested by CMV and β-globin PCRs. Among 30 latently infected patients (negative for CMV pp65 antigens), low baseline rates (10%) and levels (median number of copies, 10 [per 10 μl]) of CMV plasma DNAemia in native plasma samples increased significantly over time (after 4 h at RT, 37% [P < 0.001]; median number of copies, 45 [P < 0.001]). Similar effects were found during storage at 4°C. Ultrafiltration reduced the levels of CMV plasma DNAemia, but by 6 h of storage the levels were significantly elevated as well. CMV and β-globin DNA kinetics in plasma were parallel. In contrast, 30 actively infected patients (pp65 positive) had high baseline rates (87% in native samples) and levels (median number of copies, 75) of CMV plasma DNAemia. No significant effects of storage or ultrafiltration and no concordance with β-globin DNA kinetics were seen. In conclusion, delayed preparation of plasma samples bears a significant risk of false-positive CMV PCR results, probably due to leukocyte lysis. This has important implications in the clinical setting and for PCR standardization.

scholarly journals Coprological Detection of Bovine Fasciolosis in Federal Capital Territory, Abuja, Nigeria

2019 ◽  
Vol 1 ◽  
pp. 67-74
Author(s):  
Z Abubakar ◽  
R J Ombugadu ◽  
J D C Tongjura ◽  
G A Amuga ◽  
A B Yako
Keyword(s):  
Body Condition ◽  
Neglected Tropical Diseases ◽  
Body Condition Score ◽  
Elisa Test ◽  
Economic Losses ◽  
Faecal Samples ◽  
Condition Score ◽  
Body Condition Scoring ◽  
Gross Lesions ◽  
Liver Flukes

Bovine Fasciolosis is a vector – borne zoonosis and one of the most neglected tropical diseases that cause huge economic losses and poor animal conditions in Nigeria. The prevalence of Fasciolosis in Cattle slaughtered in the Federal Capital Territory, Abuja was investigated. Faecal samples were collected from the cattle antemortem and analysed using copro ELISA test-kits and gross lesions were inspected at postmortem. Out of one hundred and eighty six (186) faecal samples analysed, over-all prevalence was 98(52.7%). From each abattoir was 38 (38.8%), 36 (36.7%) and 24 (24.5%) at Karu, Dei-Dei and Gwagwalada abattoirs respectively. Based on body condition scoring, infection rates were 39 (58.2%), 45 (58.4%) and 20 (47.6%) from cattle with poor, moderate and good body conditions accordingly. Males had a higher prevalence rate of 48 (50%) than females with 40 (44.4%). Based on the breed of cattle, infection rate of the diseases was 41 (66.1%), 39 (62.9%) and 20 (32.3%) in White fulani, Sokotogudali and Red bororo accordingly. Out of 186 cattle inspected at postmortem, 47 livers were condemned totally due to the presence of liver flukes (Fasciola species) in the hepatic parenchyma, fluke tracts, livers were friable and chirrotic. This led to an estimated loss of about three million, one hundred and two thousand naira (3,102,000.00). There was no statistically significant association between the infection and breed, sex and body condition score (p>0.05). Treatment of all cattle with an effective flukicides, vector control, enlightening of cattle farmers for proper intervention against fasciolosis are recommended.

BCG masking phenomena might depend on the species of Mycobacterium

2021 ◽  
Author(s):  
Joana Korablioviene ◽  
Mykolas Mauricas ◽  
Irena Dumalakiene ◽  
Saulius Caplinskas ◽  
Rita Viliene ◽  
...  
Keyword(s):  
Immune Response ◽  
Antibody Response ◽  
Hypersensitivity Reaction ◽  
Mycobacterium Bovis ◽  
Mycobacterial Infection ◽  
Cross Reactivity ◽  
Primary Immunization ◽  
Wild Type ◽  
Increased Risk ◽  
Infection Susceptibility

AbstractThis study investigated BCG masking dependency on the species of Mycobacterium through the immune response to the mycobacterial region of deletion 1 (RD-1) associated growth affecting proteins (GEP).To evaluate the effects of GEP, 8-week old female BALB/c mice were immunized with either the wild type Mycobacterium bovis (MBGEP) or the ATCC Mycobacterium avium subsp. avium (MAGEP) strain and then subjected to further exposure with Mycobacterium terrae or M. avium sub. avium. Mice immunized with MAGEP and those mice further exposed to M. avium subsp. avium had increased granulocytes (GRA) and monocytes to lymphocytes rate (MLR) compared to control mice. Immunization of mice with GEP induced an antibody response one month after primary immunization, as observed by cross-reactivity. Our findings suggest that MAGEP is related to a latent hypersensitivity reaction and an increased risk of mycobacterial infection susceptibility. According to the results of the present study, previous sensitization with NTM antigens results in varying immune reactions after contact with different NTM argued that masking phenomena may be dependent on the species of Mycobacterium.

scholarly journals Histoplasmosis-Associated Cross-Reactivity in the BioRad Platelia Aspergillus Enzyme Immunoassay

2007 ◽  
Vol 14 (5) ◽  
pp. 638-640 ◽  
Author(s):  
L. Joseph Wheat ◽  
Emily Hackett ◽  
Michelle Durkin ◽  
Patricia Connolly ◽  
Ruta Petraitiene ◽  
...  
Keyword(s):  
Enzyme Immunoassay ◽  
Experimental Infection ◽  
False Positive ◽  
Second Generation ◽  
Cross Reactivity ◽  
Positive Results

ABSTRACT We observed false-positive results in the Platelia Aspergillus enzyme-linked immunoassay (EIA) for specimens from patients with histoplasmosis and mice with experimental infection. Platelia Aspergillus EIA-positive specimens were negative in the second-generation Histoplasma antigen EIA. Care must be taken to exclude histoplasmosis for patients with positive Platelia Aspergillus EIA results.

scholarly journals Age-Adjusted D-Dimer Cutoffs for DVT and Pulmonary Embolism: A Comparison of Five Assays

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1419-1419 ◽  
Author(s):  
Maria Farm ◽  
Anwar Siddiqui ◽  
Liselotte Onelöv ◽  
Roza Chaireti ◽  
Margareta Holmström ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Plasma Concentration ◽  
Venous Thrombosis ◽  
False Positive ◽  
Older Patients ◽  
Research Funding ◽  
Imaging Techniques ◽  
Increased Risk ◽  
Positive Results ◽  
D Dimer

Abstract Background: Venous thromboembolism (VTE) is a common but underdiagnosed condition constituted primarily by deep venous thrombosis (DVT, 2/3) and pulmonary embolism (PE, 1/3).Diagnosis of VTE is based on the biomarker D-dimer for excluding low probability VTE, and imaging techniques to verify mid/high probability VTE. D-dimer assays generally have excellent sensitivity, but specificity is kept low by the physiology of the measurand. The plasma concentration of D-dimer increases in thrombosis and activated coagulation, but also in several other conditions such as pregnancy, cancer, trauma, inflammation, infection and with age. Many of these conditions are especially prevalent in VTE-patients, because they are also linked to an increased risk of venous thrombosis. Haase et al. showed that the plasma concentration of D-dimer in a healthy population increases with age, 50% of those ≥70 years old had a positive D-dimer (>0.5 mg/L FEU)1. Age-adjusted decision thresholds have subsequentially been recommended and validated, to increase specificity and reduce the rate of false positive D-dimer results in older patients without decreasing sensitivity. Aims: The study compares age-adjusted D-dimer decision thresholds for different assays in Swedish out-patients with suspected DVT or PE. Methods: Patients (n=940) with clinically suspected PE or DVT in a lower limb were recruited from the medical emergency department (ED) of Karolinska University Hospital, and fresh citrated plasma samples were analyzed for D-dimer within 30 minutes. D-dimer concentrations were measured by four immunoturbidimetric assays using the instruments Sysmex CS2100i and Stago CompactMax. VTE was verified by imaging techniques (ultrasonography, computed tomography or ventilation/perfusion lung scintigraphy, as appropriate) and classified into segmental or subsegmental PE and proximal or distal DVT. Non-VTE was identified by imaging techniques or absence of VTE in a three month follow up of medical records. Age adjusted cutoff values were calculated if age was ≥50 years according to Douma et al.2, as age x 0.01 for assays measured in mg/L FEU (Siemens INNOVANCE® D-dimer and STA®-Liatest® D-Di) and as age x 0.005 for Roche Tina-quant D-dimer and as age x 0.004 for MediRox D-dimer. Results: VTE was found in 125 patients (13.3%), PE in 35 (3.7%; 3.0% segmental and 0.7% subsegmental) and DVT in 90 (9.6%; 6.3% proximal and 3.4% distal). The diagnostic performances of the assays are displayed below, see table 1. All assays had excellent areas under the ROC-curve (AUC) and all except MediRox D-dimer fulfilled the FDA requirements of sensitivity > 95% and a NPV > 97%, at the cutoff recommended by the manufacturer. When age adjusted cutoffs were applied, all assays maintained their sensitivities, whereas specificities increased by 6-7%. The rate of false positive results decreased by 6% overall, but 10-20% for patients older than 70, see table 2. Conclusion: D-dimer is still the only biomarker used for suspected VTE, even though low specificity with false positive results presents a significant problem due to an elderly patient population burdened with co-morbidity. The examined age-adjusteddecision thresholds increase specificity for VTE without decreasing sensitivity and can thus be used to improve diagnosis of VTE. With fewer false positives, diagnosis will be faster, cheaper and will result in decreased health risks from intravenous contrast, radiation and unnecessary hospital admissions. References 1. Haase C, et al. Age- and sex-dependent reference intervals for D-dimer: evidence for a marked increase by age. Thromb Res. 2013;132(6):676-80. 2. Douma RA, et al. Potential of an age adjusted D-dimer cut-off value to improve the exclusion of pulmonary embolism in older patients: a retrospective analysis of three large cohorts. BMJ. 2010;340:c1475. Disclosures Farm: Leo Pharma: Research Funding; Triolab: Honoraria; Siemens: Honoraria. Chaireti:Baxalta: Research Funding. Antovic:Siemens: Honoraria; Roche: Honoraria; Baxter Healthcare Corporation: Honoraria, Research Funding; Novo Nordisk: Honoraria; Sysmex: Honoraria; Stago: Honoraria.

Outcomes of lung cancer screening among cancer survivors: An NCCN institution experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1595-1595
Author(s):  
Bradley Maller ◽  
Vani Nath Simmons ◽  
Margaret M Byrne ◽  
Tawee Tanvetyanon
Keyword(s):  
Lung Cancer ◽  
Cancer Survivors ◽  
False Positive ◽  
Lung Cancer Screening ◽  
National Lung Screening Trial ◽  
Increased Risk ◽  
Significant Difference ◽  
Annual Screening ◽  
Positive Results ◽  
Predicted Risk

1595 Background: In 2013, the USPTF recommended low-dose CT (LDCT) screening for individuals at high risk of lung cancer based on data from the National Lung Screening Trial. However, the trial excluded participants with cancer diagnosis < 5 years except for non-melanoma skin cancer, making it unclear whether the data will be generalizable to cancer survivors. This population, while at increased risk of secondary lung cancer, may be prone to false positive results due to anatomic defects or recurrent cancers. Our NCCN institution serves a large number of cancer survivors. We evaluated the outcomes of LDCT screening and the adherence to annual screening among cancer survivors, compared with individuals without cancer history (IWC). Methods: Prospectively maintained database of LDCT screening participants was analyzed. Eligibility was per NCCN criteria and cancer survivors needing regular chest CT were not offered LDCT. Participants were asked to complete a self-administered questionnaire on risk factors. Positive result was defined as Lung-RADS ≥3, corresponding to nodule ≥6 mm. Adherence to LDCT screening was defined as having T1 screening, excluding those < 18 months from T0 at time of analysis. Predicted risk of lung cancer was calculated per PLCOm2012 model. Results: To date, 454 subjects have undergone LDCT screening. Positive results occurred in 60 subjects (13.2%) at T0; lung cancer was diagnosed in 10 subjects (2.2%); and other cancers were diagnosed in 5 subjects (1.1%). There were 152 cancer survivors, including survivors of breast (52), prostate (26), bladder or kidney (19), lung (14), and head and neck cancer (13). The median time from cancer treatment to LDCT screening was 6 years (range 0-55). Cancer survivors were older than IWC: median age 67.4 vs. 63.5 years ( p< 0.001) and more likely to be active smokers: 37.5% vs. 29.5%, ( p= 0.09). The median predicted risk of lung cancer at 6 year was 5.5% vs. 3.2%, ( p= 0.15). No significant difference in the screening outcomes was found between groups. Among cancer survivors (N = 152), positive screening occurred in 15 (9.9%); lung cancer was diagnosed in 1 (0.7%); and other cancers were diagnosed in 3 subjects (1.9%). Non-adherence to LDCT screening occurred in 31 out of 152 cancer survivors (20.4%), compared with 81 out of 262 (30.9%) IWC, ( p= 0.02). Conclusions: About one-third of LDCT screenings at this NCCN institution occurred among cancer survivors. We found no evidence of increased false positive results. However, a higher rate of adherence to annual screening was observed among cancer survivors than IWC.

scholarly journals Cross-reactivity of SARS-CoV-2 with HIV chemiluminescent assay leading to false-positive results

2020 ◽  
pp. jclinpath-2020-206942
Author(s):  
Shaun S Tan ◽  
Ka Lip Chew ◽  
Sharon Saw ◽  
Roland Jureen ◽  
Sunil Sethi
Keyword(s):  
False Positive ◽  
Cross Reactivity ◽  
Positive Results

scholarly journals Evaluation of Association Studies and an Updated Meta-Analysis of VDR Polymorphisms in Osteoporotic Fracture Risk

2022 ◽  
Vol 12 ◽  
Author(s):  
Yi-yang Mu ◽  
Biao Liu ◽  
Bin Chen ◽  
Wang-fa Zhu ◽  
Xiang-Hua Ye ◽  
...  
Keyword(s):  
Vitamin D ◽  
Fracture Risk ◽  
Osteoporotic Fracture ◽  
False Positive ◽  
Association Studies ◽  
Meta Analysis ◽  
European Countries ◽  
Increased Risk ◽  
Positive Results ◽  
Vdr Polymorphisms

Background: Several studies have examined the association between vitamin D receptor (VDR) polymorphisms and osteoporotic fracture risk; however, the results are not uniform. Furthermore, many new articles have been published, and therefore, an updated meta-analysis was performed to further explore these issues.Objectives: The aim of the study was to investigate the association between VDR, BsmI, ApaI, TaqI, FokI, and Cdx2 polymorphisms and osteoporotic fracture risk.Methods: The odds ratios (ORs) and 95% confidence intervals (CIs) were used to assess the association between VDR BsmI, ApaI, TaqI, FokI, and Cdx2 polymorphisms and the risk of osteoporotic fracture. We also used the false-positive reporting probability (FPRP) test and the Venice criteria to evaluate the credibility of the statistically significant associations.Results: Overall, this study found that the VDR ApaI and BsmI polymorphisms significantly increased the risk of osteoporotic fracture in European countries and America, respectively. However, when sensitivity analysis was performed after excluding low-quality and Hardy–Weinberg disequilibrium (HWD) studies, it was found that only individuals with the double-mutated genotype have an increased risk of osteoporotic fracture in European countries. In addition, when the credibility of the positive results was assessed, it was found that the positive results were not credible.Conclusion: This meta-analysis indicates that there may be no significant association among the polymorphisms of VDR BsmI, ApaI, TaqI, FokI, and Cdx2 and the risk of osteoporotic fracture. The increased risk of osteoporotic fracture is most likely due to false-positive results.

scholarly journals Comparative research of diagnostic efficiency of ELISA test systems of domestic and foreign production for Animal brucellosis diagnostics

2019 ◽  
pp. 63-68
Author(s):  
B. T. Stegniy ◽  
S. S. Drahut ◽  
V. A. Kutsenko ◽  
T. P. Ramazanova ◽  
N. V. Marchenko ◽  
...  
Keyword(s):  
Positive Result ◽  
Francisella Tularensis ◽  
False Positive ◽  
Elisa Test ◽  
Farm Animals ◽  
Specific Antibodies ◽  
Milk Samples ◽  
Maximum Value ◽  
Test Kit ◽  
Positive Results

The purpose of the work. Comparison the diagnostic ability of the ELISA test kits «DIA®-Brucella ab. combi-V» and «ID Screen® Brucellosis Serum Indirect Multi-species» for the detection of antibodies to brucellosis pathogens in various farm animals. Materials and methods. For the analysis there were used 29 positive samples to brucellosis with specific antibodies in different concentrations, 26 of which are serums (22 — from cattle, 2 — from pigs, 1 — from goat, 1 — from camel) and 3 — milk samples from cows. There were used 32 serums (23 — from cattle, 6 — from sheep, 2 — from pigs, 1 — from goat), and 2 milk samples from cows that don’t contain antibodies to brucellosis pathogens for determining the ability of test kits to detect correctly negative samples. There were also used serums from cattle containing antibodies that can lead to false positive results, 1 sample with antibodies to Francisella tularensis, 1 — to Yersinia 03 and 1 — to Yersinia 09. To compare the results in the two test kits, comparative ratios were used that allowed to determine how many times the result obtained in both test kits was higher or less than cut off, that differentiated positive samples from negative. Results of the work. When analyzing 22 cattle serums containing antibodies to B. abortus, the “DIA®-Brucella ab. combi-V” kit determined all samples positive with a results 5.3–10.6 times higher than cut off. The “ID Screen® Brucellosis Serum Indirect Multi-species” test kit identified only 18 positive serums with a maximum value of 1.3 above the cut off. The result of the analysis of 3 samples was doubtful and 1 serum was negative. When analyzing 4 sera from different animals containing antibodies to brucellosis pathogens, the “DIA®-Brucella ab. combi-V” test kit identified all positive samples with the results 8.1–9.4 times higher than cut off. The “ID Screen® Brucellosis Serum Indirect Multi-species” test kit detected specific antibodies in only 3 serums — from pigs and camel. When the goat serum was tested, a doubtful (uncertain) result of the analysis was obtained. When analyzing 3 milk samples from cows containing antibodies to B. abortus in different concentrations there was received a positive result to brucellosis in both test kits. However, ability of the “DIA®-Brucella ab. combi-V” test kit to detect specific antibodies was significantly higher than in comparison test kit. When investigating 32 serums from different animals and 2 milk samples that didn’t contain antibodies to the brucellosis pathogens, a negative result of the analysis was obtained in both test kits. When analyzing cattle serums containing antibodies that can lead to false positive results, both test kits identified 1 sample with antibodies to Francisella tularensis and 1 serum with antibodies to Yersinia 03 with negative result. When analyzing 1 serum with antibodies to Yersinia 09 the result of the analysis was false positive. Conclusions. Studies have shown that the “DIA®-Brucella ab. combi-V” test kit has a high diagnostic capacity. When analyzing 29 blood serums, including samples from different animals, and milk samples from cows containing antibodies to brucellosis pathogens, the test kit identified all samples as positive with results 5.3–10.8 times above the cut off. The “ID Screen® Brucellosis Serum Indirect Multi-species” test kit detected antibodies to brucellosis pathogens only in 24 samples with a maximum value 1.3 times higher than cut off. When investigating 4 serums, 3 samples of which are from cattle and 1 — from goat, the result of the analysis was doubtful (uncertain), 1 cattle serum was identified as negative. The ability of test kits to detect correctly negative samples was comparable. When analyzing 32 serums from different animals and 2 milk samples from cows that do not contain antibodies to brucellosis pathogens, in both test kits, a negative result of the analysis was obtained. For the 3 negative cattle serums, the analysis of which on brucellosis may be incorrect (the presence of antibodies to Yersinia О3, Yersinia О9, Francisella tularensis), in both test kits, for 1 sample with antibodies to Yersinia О9 a false positive result was obtained

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

Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1124
Author(s):  
Christopher C. Lamb ◽  
Fadi Haddad ◽  
Christopher Owens ◽  
Alfredo Lopez-Yunez ◽  
Marion Carroll ◽  
...  
Keyword(s):  
False Positive ◽  
Point Of Care ◽  
Rapid Test ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Blood Collection ◽  
Rt Pcr ◽  
Antibody Testing ◽  
Reactivity Study ◽  
Positive Results

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.

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