BinaxNOW COVID-19 Ag Card
For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's EUA.
Kit Details
Test Card: 40 cards with test strips
Extraction Reagent: bottle containing 7.5 mL of extraction reagent
Nasal swabs: 40 sterile, single use specimen sampling swabs
Positive Control Swab: 1 each â??individually wrapped for single use
Negative Control Swab: 1 each â??individually wrapped for single use
Documentation: Product Insert, Procedure Card
Performance Data
[Intended Usage]
This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites.
[Storage Conditions & Validity]
1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box.
2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times.
3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period.
[Applicable Instruments]
1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument.
2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support.
NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels.
[Sample Requirements]
1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices.
[Test Results Interpretation]
1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements.
2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition.
3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample.
[Product Performance Index]
1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%.
2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%.
3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL.
INTENDED USE
For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection.
FEATURES
Coated with carefully selected specific Nucleocapsid and Spike protein antigen.
Detection for IgM and IgG antibodies simultaneously.
Simple operation, easy result interpreted.
Rapid test within 15 minutes.
RESULTS INTERPRETATION
Positive:
1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies.
2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody.
3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody.
Negative:
1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative.
Invalid:
1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested.
2. The test result is invalid after 15 min.
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The COVID-19 RT-PCRT est is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test can be run in a singleplex format (three individual assays) or multiplexed into a single reaction and amplification set up.
CareStarfTM COVID-19 ANTIGEN RAPID TESTS
Why CareStartTM
COVID-19 Live infection 10 minutes Diagnostic Tests dose not require a machine reader! Abbott, Quidel, and BD require readers, that are in short supply.
â?¢ EASY TO USE
CareStart
â?¢ AVAILABILE Rapid Tests on the shelf available products (in inventory) with
We offer CareStartTM
reliable production and delivery schedules. Abbott, Quidel and BD testing cassettes are
in short supply with unreliable availability.
â?¢ FDA EUA
is currently the only Point-Of-Care rapid antigen test registered authorized under the FDA EUA.
CareStart
TM
CareStarfTM COVID-19 ANTIGEN RAPID TESTS Features
Identify individual's current infection status to COVID-19 Fast and easy to use in Point-of-Care setting
Qualitatively detect the SARS-CoV-2 nucleocapsid protein Use nasopharyngeal (NP) swab specimens
Reliable results only in 1O minutes
No special equipment or training required All-in-one package including collection swabs
High sensitivity (88.4�°/o) and specificity (100�°/o) Kit Components
20 test devices
20 extraction vials and caps
20 NP swabs
1 positive and 1 negative controls Package insert
Quick reference Instructions (QRI)
gg/igm double antibody is 15 minutes out of the accuracy of more than 90% or even up to 98%COVID 19 diagnostic kit is used for the qualitative detection of new coronavirus (2019-nCoV) antibodies in human whole blood, serum and plasma.
Coronavirus (CoV) belongs to the order Nestivirus, Coronaviridae, and divided into three genera: �±, �², and �³. The alpha and beta gene are only pathogenic to mammals. The gamma gene mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route.
There have been seven types of human coronavirus (HCoCoV and 2019-nCoV), which are important pathogens of human respiratory tract infection.Among them, the new coronavirus (2019-nCoV) was found for 2019 cases of viral pneumonia in Wuhan. The clinical manifestations are systemic symptoms such as fever, fatigue, dry cough, dyspnea, which can quickly develop into severe pneumonia, respiratory failure, acute Respiratory distress syndrome, toxic shock, multiple organ failure, severe acid-base metabolism disorders and even life-threatening.
2019-nCoV Antibody Diagnostic Kit uses the principle of immunochromatographic method to qualitative detect the coronavirus (2019-nCoV) antibody in human whole blood, serum and plasma. It is used for clinical diagnosis of primary infection or secondary infection of new type of coronavirus infection pneumonia.
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