This kit is intended for qualiativein vitro detection of Orf1ab and N genes of Novel Coronavirus 2019-nCoV which are found in throat swab,sputum and alveolar lavage fuid samples of suspected cases of pneumonia,suspected cases of clustering and other patients who need to carry out diagnosis or differential diagnosis of Novel Coronavirus 2019-nCoV infection.
The disposable virus sampling tube/Virus Transport Medium(VTM) is suitable for nucleic acid extraction of SARS-CoV-2 virus, various influenza viruses, avian influenza viruses, rubella, swine fever and other virus samples.
The disposable virus sampling tube/Virus Transport Medium(VTM) is suitable for nucleic acid extraction of SARS-CoV-2 virus, various influenza viruses, avian influenza viruses, rubella, swine fever and other virus samples. It is also suitable for the collection and transportation of specimens of Chlamydia, Mycoplasma, and Mycoplasma Arthroplasma. Samples are usually collected from the mouth, throat, nasal cavity, and anus.
Sampling tube: The tube body and tube cover are made of polypropylene, which will not deform at high temperature and high pressure (121C, 15min), and will not become brittle at low temperature (196C). Resistant to static extrusion and dynamic impact. The bottom tapered design is resistant to centrifugation and vibration. Built-in sample preservation solution is used for sample preservation to prevent leakage.
Sample preservation solution: Functioned with virus lysis solution and virus nucleic acid preservation solution. The virus lysate realizes the inactivation of the virus in the sample and reduces the risk of secondary infection. The unique protection system can prevent nucleic acid from being degraded and improve the accuracy of downstream detection. The sample has a wide adaptability and can be used for the collection, preservation and transportation of various swabs.
Sampling swabs: sampling swabs are flocking sampling heads, which are non-toxic to cells and viruses, and do not contain RNase, which can greatly increase the collection and release of virus samples , ensure the accuracy of PCR detection results. The plastic rod is made of ABS, with a unique molded breaking point design, and there is no tiny debris during the breaking process.
Features:
1.More collection and release:nylon flocked swabs provide optimum specimen collection because of their ability to collect more specimen at the collection site and to more rapidly release the entire samples specime
2. High safety factor: it can lyse pathogens, inactivate viruses, and reduce the risk of secondary infection.
3. Stable nucleic acid: a unique protection system that can prevent nucleic acid from being degraded and improve the accuracy of downstream detection.
4. Wide sample adaptability: it can be used for the collection, preservation and transportation of various swabs,Including oral swabs, throat swabs, nasal swabs, vaginal swabs and so on.
[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.
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.
When the epidemic is waiting for an opportunity again, to quickly control the spread of the virus, nucleic acid testing has become the only way to go, and it has also attracted attention from all walks of life. However, there are many factors that affect the results of nucleic acid testing, including sample collection location, collection method, storage and transportation process, nucleic acid extraction operation, and so on. Among them, the stability of the sample is a key link. How to quickly inactivate the virus and protect the viral nucleic acid from being degraded, maintaining the stability of the virus sample storage solution has become a top priority.
Step 1: Break the shell and eliminate the "combat power"
Like other RNA viruses, the results of the new coronavirus are simply composed of a protein shell wrapped in single-stranded nucleic acid-RNA. We can simply think of the RNA of the virus as the "brain" that gives orders, and the protein is the "limbs" that execute orders. The new coronavirus infects the human body and reproduces and causes symptoms. This process is mainly completed by the biologically active protein structure outside the virus.
The inactivated virus preservation solution is mainly the virus modified by the nucleic acid extraction lysis solution; it is a powerful protein denaturant that can quickly dissolve the protein and cause the virus structure to be broken. When the clinical sample with the new coronavirus is mixed with the preservation solution, the virus in the sample is affected by the lysis solution, and the protein shell is quickly destroyed, and this damage is irreversible. At this time, the virus has lost its evil "minions" and no longer has the ability to infect people, thus ensuring the safety of contacts during sample transportation and processing.
Step 2: Inhibit enzyme activity and escort the "ID card"
After the shell is lysed, the RNA of the new coronavirus is free in the preservation solution. As a single-stranded macromolecule, the stability of RNA is not as immobile as double-stranded DNA. The RNase that exists everywhere in the natural environment is the culprit that causes RNA to hydrolyze and break. Therefore, it is generally considered that the viral RNA that has lost its outer shell protection is
In addition to the inactivated virus storage solution, the virus preservation solution produced by Desheng also has a non-inactivated virus storage solution. It retains the protein coat of the virus and the viral nucleic acid DNA or RNA at the same time, so that the virus has the integrity of the protein epitope and nucleic acid in vitro. Of course, there is a certain risk of infectivity when operating errors. Long-term storage after sampling needs to keep strictly low temperature. Regardless of the virus preservation solution, we need to strictly operate, store or transport in accordance with the requirements when using it.
With the recurrence of asymptomatic, nucleic acid testing cannot be stopped for a moment. This is not only a protection for everyone, but also a protection for yourself. Speaking of nucleic acid testing, we have to bring up our virus sampling tube again. Its choice also plays a key role.
Why use a virus sampling tube?
Virus detection is different from conventional biochemical detection. The virus itself is a simple microorganism that must be parasitic in living cells. After sampling, the virus leaves the host cell, and its protein shell and nucleic acid will be quickly degraded in the sampling tube, so the nucleic acid During the test, it is impossible to determine whether the initially collected sample contains the virus, and it is easy to cause false negatives.
What are the requirements for an excellent virus sampling tube?
1. In terms of sample effectiveness: The non-inactivated virus preservation solution must maintain the activity of the pathogen's infectious agent. Preferably, it can preserve the activity of the virus at room temperature. The inactivated virus preservation solution needs to inactivate the virus but maintain the nucleic acid of the virus to meet the time from sample sampling to laboratory testing. It is necessary to limit and prevent the reproduction of symbiotic microorganisms to ensure the reliability of diagnostic tests.
2. In terms of safety: Because the virus sampling tubes are basically all infectious substances, and some are highly pathogenic infectious substances, the requirements for packaging containers are very strict, and they need to meet safety and ensure that liquids do not leak during transportation. .
So what is the virus preservation solution? Under what circumstances do I need to use a virus preservation solution?
The virus preservation solution is a protective liquid medium added to the virus sampling tube to protect the sample after the nasopharyngeal swab is sampled. Normally, nucleic acid PCR cannot be directly performed at the sample collection site during nucleic acid detection. If the sample collected by the swab needs to be transferred and transported, it is necessary to add a virus preservation solution.
Why is the virus preservation solution divided into inactivated and non-inactivated?
After the virus samples are collected, there is usually no way to test in time at the sample sampling site, so the collected virus swab samples need to be transported, and the virus itself will be quickly lysed outside the body and affect subsequent testing, so when storing and transporting , You need to add a virus preservation solution. For different detection purposes, you need to use different virus preservation solutions and different virus detection experimental conditions, so it is divided into two types of preservation solutions, inactivated and non-inactivated.
There are no other microorganisms, causing the virus to decompose after sampling or other influences causing false detections.
Standard Q Covid 19 Ag is a rapid chromatographic immunoassay for the qualitative detection of antigens specific to SARS-CoV-2 in swab samples collected from a human nasopharynx.
Fast results within 15~30 mins
Easy to useSpecimen : Nasopharyngeal swab
All necessary reagents provided & no equipment needed
Used for collection, transport and long term storage of clinical specimens for molecular analysis.
Collected samples can be stored at ambient temperature (25-30 Degree C) .
Specially formulated for inactivation of viral material, ensures safety of handling personnel involved.
Screw caps with o-ring for zero leakage.
Externally sealed with parafilm.
Extra film provided with each test.
Skirted, self standing 15 ml collection tubes with nasal & throat swabs.
One-step real-time-PCR test for qualitative detection of genetic material of SARS-CoV-2 virus in upper and lower respiratory specimens collected from individuals
suspected of COVID-19 infection.
Targets the RdRp gene and E gene.
Products with high specificity and sensitivity for accurate and reliable results.
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