OBJECTIVEEvaluating the accuracy and safety as well as the equivalence compared with the control kit of RIDA QUICK Norovirus detection kit(R-Biopharm, Germany).

METHODSBased on the results of commercially available IDEA Norovirus detection kit (ELISA), the sensitivity and specificity and accuracy of RIDA QUICK Norovirus detection kit (immunochromatographic assay) were evaluated.

RESULTSThe sensitivity and specificity of RIDA QUICK Norovirus detection kit were 98.4% and 92.4%, and the accuracy was 97.6% compared with the control kit.

CONCLUSIONRIDA QUICK Norovirus detection kit has good sensitivity and specificity for the detection of norovirus antigens.

Enzyme-Linked Immunosorbent Assay ; methods ; Humans ; Immunochromatography ; methods ; Norovirus ; isolation & purification ; Reagent Kits, Diagnostic ; Sensitivity and Specificity

BACKGROUND: Rotavirus is a major pathogen causing enteritis worldwide in children under five years of age. In recent years, immunochromatographic assay (ICA) has been widely used as a diagnostic test for rotavirus detection. This study aimed to compare and evaluate the performance of ICA-based rotavirus rapid test kits from two manufacturers. METHODS: Residual stool samples from a total of 130 children with acute enterocolitis from November 2017 to January 2018 were used. We compared the results of the two immunochromatographic methods (SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test) with those of the currently used enzyme immunoassay method. RESULTS: Positive agreement, negative agreement, and total agreement rates between the SD BIOLINE rotavirus kit and the enzyme immunoassay were 98.0%, 100%, and 99.2%, respectively. Positive agreement, negative agreement, and total agreement rates between the GENEDIA Rotavirus Ag Rapid Test and the enzyme immunoassay were 96.0%, 100%, and 98.4%, respectively. CONCLUSIONS: Both rotavirus rapid test kits showed very good agreement with the conventional enzyme immunoassay. Therefore, it could be a useful test to detect rotavirus directly from stool samples in a short time.
Child ; Diagnostic Tests, Routine ; Enteritis ; Enterocolitis ; Humans ; Immunochromatography ; Immunoenzyme Techniques ; Methods ; Rotavirus

Mycobacterium (M.) bovis, a bacterium in the M. tuberculosis complex, is a causative agent of bovine tuberculosis, a contagious disease of animals. Mycobacterial culture is the gold standard for diagnosing bovine tuberculosis, but this technique is laborious and time-consuming. In the present study, performance of the SD Bioline TB Ag MPT4 Rapid test, an immunochromatographic assay, was evaluated using reference bacterial strains and M. bovis field isolates collected from animals. The SD MPT64 Rapid test produced positive results for 95.5% (63/66) of the M. bovis isolates from cattle and 97.9% (46/47) of the isolates from deer. Additionally, the test had a sensitivity of 96.5% (95% CI, 91.2-99.0), specificity of 100% (95% CI, 96.7-100.0), positive predictive value of 100% (95% CI, 96.7-100.0), and negative predictive value of 92.9% (95% CI, 82.7-98.0) for M. bovis isolates. In conclusion, the SD MPT64 Rapid test is simple to use and may be useful for quickly confirming the presence of M. bovis in animals.
Animals ; Cattle ; Cattle Diseases/*diagnosis/microbiology ; *Deer ; Immunochromatography/methods/*veterinary ; Mycobacterium bovis/classification/*isolation & purification ; Sensitivity and Specificity ; Tuberculosis/diagnosis/microbiology/*veterinary

To develop a specific, rapid, and convenient immunochromatography assay (ICA) to detect melamine residues in dairy products and feed sample. Colloidal gold particles labeled with purified monoclonal antibody against anti-melamine were used as the detector reagent. The MEL-OVA (the conjugate of melamine and ovalbumin) and goat anti-mouse melamine IgG were blotted on the test and control regions of nitrocellulose membrane. The strip was then assembled with sample pad, absorbing pad, and dorsal shield. The limit of detection (LOD) is 50 microg/L. The test trip was applied to detect melamine in milk, milk powder, and animal feeds, with detection limits of 100 microg/L for milk, 100 ng/g for milk powder, 200 ng/g for feeds. Compared to LC-MS/MS, the ICA could be used to screen a large number of dairy products and feed samples for melamine residue.
Animals ; Antibodies, Monoclonal ; chemistry ; Cattle ; Dairy Products ; analysis ; Food Contamination ; analysis ; Gold Colloid ; chemistry ; Immunochromatography ; methods ; Milk ; chemistry ; Reagent Strips ; chemical synthesis ; chemistry ; Sensitivity and Specificity ; Triazines ; analysis

PURPOSE: To evaluate the feasibility for gold immunochromatographic assay (GICA) in rapid detection of influenza virus A infection. MATERIALS AND METHODS: Seventy-three patients were enrolled. All patients contributed nasopharyngeal secretions and paired serum samples. Nasopharyngeal secretions was used for colloidal gold immunochromatographic rapid assay for influenza A virus immediately after the collection of specimen. Paired serum samples were used for the hemagglutination inhibition assay at the Centers for Disease Control and Prevention influenza network laboratory in Beijing. RESULTS: Compare GICA test to hemagglutination inhibition (HI) assay, the Kappa value was 0.402 and the p value in the paired chi2 test was higher than 0.05. Therefore, the difference was not statistically significant. The sensitivity of GICA was 50.0% and the specificity was 90.2%, and the negative predictive value was 90.2%. CONCLUSION: The sensitivity for Influenza A antigen detection by using GICA is relatively low, the specificity is relatively satisfactory.
Adult ; Aged ; Aged, 80 and over ; Antigens, Viral/*blood ; Female ; *Gold Colloid ; Humans ; Immunochromatography/*methods ; Influenza A virus/*immunology ; Influenza, Human/*diagnosis/immunology ; Male ; Middle Aged ; Reagent Kits, Diagnostic ; Sensitivity and Specificity

To develop a specific, rapid, and convenient immunochromatography assay (ICA) to detect the rabies antibody in clinical sample from immuned dogs by rabies vaccine. Colloidal gold particles labeled with purified rabies virus (CVS11) were used as the detector reagent. The staphylococcal protein A (SPA) and pured rabbit anti-rabies virus IgG were blotted on the test and control regions of nitrocellulose membrane. Then the strip was assembled with sample pad, absorbing pad, and dorsal shield. The assay samples (261 dog's serum) were collected from Wildlife Rabies Disease Diagnostic Laboratories of Ministry of Agriculture in China, Institute of Military Veterinary, Academy of Military Medical Sciences and other six provinces, including rabies virus positive and negative serum. The performance of the strip was compared to fluorescent antibody virus neutralization test. The neutralizing antibody titer could be detected above 0.5 IU. The strip did not change of performance when stored at room temperature for 12 months. It may offer reference of neutralizing antibody titer level after dogs immuned rabies vaccine and determin whether the dogs need to be immuned again.
Animals ; Antibodies, Neutralizing ; analysis ; blood ; Antibodies, Viral ; analysis ; blood ; Dogs ; Gold Colloid ; Immunochromatography ; methods ; Rabies ; prevention & control ; veterinary ; Rabies Vaccines ; immunology ; Rabies virus ; immunology ; Reagent Strips ; Sensitivity and Specificity ; Vaccination

We evaluated the IP-Triple I immunochromatographic rapid test for the detection of rotavirus, norovirus and adenovirus using stool samples from children with diarrhoea. The detection of norovirus and adenovirus was poor compared to polymerase chain reaction assays. However, high sensitivity (92%) and specificity (99%) were obtained for the detection of rotavirus.
Adenoviridae/*isolation & purification ; *Child, Hospitalized ; Child, Preschool ; Diarrhea/*virology ; Disease Outbreaks ; Feces/virology ; Female ; Humans ; Immunochromatography/*methods ; Infant ; Infant, Newborn ; Male ; Norovirus/*isolation & purification ; Polymerase Chain Reaction ; Rotavirus/*isolation & purification ; Sensitivity and Specificity

Porcine reproductive and respiratory syndrome (PRRS) is recognized as one of the most important infectious diseases causing serious economic loss in the swine industry worldwide. Due to its increasing genetic diversity, a rapid and accurate diagnosis is critical for PRRS control. The immunochromatographic strip test (ICST) is a rapid and convenient type of immunoassay. In this study, an on-site immunochromatographic assay-based diagnostic method was developed for detection of PRRS virus (PRRSV)-specific antibodies. The method utilized colloidal gold nanoparticle-labeled dual-type nucleocapsid proteins encoded by open reading frame 7. We evaluated 991 field samples from pig farms and 66 serum samples from experimentally PRRSV-inoculated pigs. Based on true PRRSV-specific antibody-positive or
Agriculture ; Antibodies ; Colloids ; Communicable Diseases ; Diagnosis ; Enzyme-Linked Immunosorbent Assay ; Fluorescent Antibody Technique ; Genetic Variation ; Gold Colloid ; Immunoassay ; Immunochromatography ; Immunoglobulin M ; Methods ; Nucleocapsid Proteins ; Open Reading Frames ; Porcine Reproductive and Respiratory Syndrome ; Porcine respiratory and reproductive syndrome virus ; Sensitivity and Specificity ; Swine

BACKGROUND/AIMS: M2 pyruvate kinase (M2-PK) is an enzyme that is produced in undifferentiated and proliferating tissues. This study aims to evaluate the usefulness of the immunochromatographic M2 pyruvate kinase (iM2-PK) for the screening of colorectal cancer (CRC) and premalignant lesions. METHODS: Healthy volunteers and patients with colorectal neoplasia were enrolled in six academic hospitals in the capital province of Korea. The iM2-PK value was compared with the immunochromatographic fecal occult blood test (iFOBT) and fecal tumor M2-PK enzyme-linked immunosorbent assay (ELISA). RESULTS: A total of 323 subjects were enrolled. The sensitivity of iM2-PK for CRC was 92.8%, which was superior to iFOBT (47.5%, p<0.0001). For adenomatous lesions, the sensitivity of iM2-PK was 69.4%, which was also superior to iFOBT (12.1%, p<0.001). Compared with M2-PK ELISA, iM2-PK exhibited significantly enhanced sensitivity for CRC (97.5% vs 80.0%, p=0.0289). The sensitivity of iM2-PK was higher in advanced stages of CRC compared with cancers confined to the mucosa and submucosa (p<0.05). However, lymph node metastasis had no influence on the sensitivity of iM2-PK. CONCLUSIONS: The iM2-PK exhibited increased sensitivity for identifying CRC and adenomatous lesions compared with iFOBT. Given its rapid results and convenience, CRC screening using iM2-PK is promising.
Adenoma/*diagnosis ; Adult ; Aged ; Aged, 80 and over ; Biomarkers, Tumor/*analysis ; Clinical Enzyme Tests/*instrumentation ; Colorectal Neoplasms/*diagnosis ; Enzyme-Linked Immunosorbent Assay ; Feces/*enzymology ; Female ; Healthy Volunteers ; Humans ; Immunochromatography/methods ; Male ; Middle Aged ; Occult Blood ; Precancerous Conditions/diagnosis/enzymology ; Predictive Value of Tests ; Pyruvate Kinase/*analysis ; Reagent Kits, Diagnostic ; Republic of Korea ; Sensitivity and Specificity