PERFORMANCE SPECIFICATIONS
1. Detection limitation: 200 copies /mL.
2. Precision: using precision reference CV1 and CV2 for within-batch and
between-batch detection, the coefficient of variation (CV) of their Ct values
is â?¤ 5.0%.
3. Conformity rate of Negative Control: 100%
4. Conformity rate of Positive Control: 100%
5. Specificity: This product will not cross react with positive samples of
human coronavirus HKU1 OC43, NL63 and 229E, SARS coronavirus, MERS
corona-virus, H1N1 (new influenza A (H1N1) virus (2009), the seasonal
H1N1) and H3N2, H5N1, H7N9, influenza B Yamagata, Victoria, respiratory
syncytial virus type A, B, parainfluenza type 1, 2, 3, rhinovirus species A, B
and C, adenovirus, 1, 2, 3, 4, 5, 7 and 55, enterovirus species A, B, C,
D,Human pulmonary virus, partial pulmonary virus, EB virus, measles virus,
human cytomegalo virus, rotavirus, norovirus, mumps virus, varicella-zoster
virus and mycoplasma pneumoniae, chlamydia pneumoniae, legionella,
bordetella pertussis, haemophilus influenzae, staphylococcus aureus,
streptococcus pneumoniae, pyogenic streptococcus, klebsiella pneumoniae,
mycobacterium tuberculosis, pyogenic streptococcus, candida albicans,
candida glabrata, newborn Cryptococcus and human genome DNA.
This kit utilizes fluorescence quantitative probe-based PCR and guarantees a high specificity to ensure accurate one-step identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 500 copies/ml. The results are available within 1.5 hour.
Kit Contents (48 Tests /Kit)
Dual Enzyme solution A 50 µl
Dual Ncvo-O / N reaction solution A 1 ml
Dual Ncvo-O / N positive control A 200 µl
Dual Negative control A 200µl
Applicable equipment
ABI series, Bio-Rad, Roche series and other fluorescent real-time PCR instruments.
Specimens requirements
Specimen type: nasopharyngeal swab from suspected infection; virus cell culture fluid, etc.
Basic Protocol
1. Sample preparation.
Take the test sample and extract the RNA nucleic acid according to the instructions of the nucleic acid extraction kit. The nucleic acid extraction product should be stored at -20 C.
2. Reaction mixture preparation
According to the total number of test samples, the number of PCR reaction tubes needed is. N = number of samples + 1 negative control + 1 positive control.
The following protocol is recommended for a 20 µl reaction volume. If the volume of reaction changes, please adjust proportionally.
Components Volume
Dual Enzyme solution A 1 µl
Dual Ncvo-O / N reaction solution A 19µl
Final Volume: 20 µl
3. Sample adding.
Add 5 µl each of the extracted RNA, positive and of negative control to corresponding reaction tubes. After assembling all the components, cover the tube caps and gently mix the contents of the tube, mix well, and centrifuge briefly.
4. Perform quantitative PCR
Place the reaction tube inside a real-time PCR instrument.
Set the channel and sample information, reaction system volume 25 µl.
Select the following channels: FAM channel for nCOV-ORF1ab, VIC channel for nCOV-N.
Perform quantitative PCR using recommended cycling parameters settings:
Step Temperature Time Number of cycles Fluorescence Detector
1 50C 15 min 1 Off
2 95C 3 min 1 Off
3 95C 10sec 45 Off
60C 30 sec On
Result analysis:
1) Set the baseline: Generally, it is set to 6-15cycle for ABI 7500, 7700 and other instruments, 3-15cycle for PE5700, and 6-12cycle for MJ Research Option2. Under special circumstances, the baseline can be adjusted accordantly.
2) Set the threshold: The threshold line just exceeds the highest point of the negative control amplification curve (random noise line).
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Vannin Healthcare offers several effective COVID-19 tests:
SGTi-flex COVID-19 IgM/IgG (25 tests per kit)
STANDARD Q COVID-19 IgM/IgG Duo Test (40 tests per kit)
Anti-SARS-CoV-2 Rapid Test (50 tests per kit)
General Features
Can detect and differentiate between IgM and IgG antibodies
Convenient: no additional equipment necessary
Extremely fast: results in 10-15 minutes
Point-of-care testing
Allow rapid decision-making in high-stakes situations
Why our tests
Certified: CE-IVD marked, FDA-cleared, ISO 13485, Korea GMP-certified
Reliable: high clinical specificity and selectivity
Easy to interpret
Can detect antibodies even in asymptomatic patients
Vannin Healthcare Global offers various diagnostic and serology tests for identifying the presence of Severe Acute Respiratory Syndrome Coronavirus2 (SARS-CoV-2). SARS-CoV-2 is the virus that causes COVID-19 which means that its presence could indicate that a person has been infected.
There are two types of tests currently used to determine the presence of the virus:
To find out whether antibodies are present in an obtained sample (whole blood, plasma, or serum), serology tests are used. The presence of antibodies could indicate a past infection. And depending on the type of the immunoglobulins present, it could also determine the approximate time when the infection occurred.
After fighting a coronavirus, our bodies are likely to produce two classes of antibodies: IgM and IgG. In the case of SARS-CoV-2, both IgM and IgG are most likely to occur simultaneously within two to three weeks after a person's been infected. For a firmer diagnosis, Vannin Healthcare Global offers serology tests that check for both IgM and IgG antibodies.
Can detect and differentiate between IgM and IgG antibodies
Differentiating between the antibodies is crucial when it comes to providing proper medical advice to your patients. The appearance of IgM antibodies is the initial response of the organism fighting to suppress the virus. These antibodies could indicate that the patient is still infectious, and advising patients to self-isolate is the appropriate course of action. IgG antibodies can be detected in the blood sample usually within7-10 days after the onset of infection. If a patient has IgG antibodies, and no IgM antibodies, they have developed a temporary immunity to COVID-19.
No additional equipment necessary
The test design makes it a perfect choice for remote areas without access to fully-equipped laboratories. Simply obtain a blood sample from a patient, and add 10�µl into the appropriate place on the testing cassette along with three drops (90µl) of the buffer. The results will appear in 10-15 minutes.
FAST: Results in under 2 minutes
ACCURATE: 99.9% specificity and 98.7% sensitivity
EASY TO USE: Convenient for testing at home
PAINLESS: Simple and painless saliva collection
RELIABLE: 24-Hour RT-PCR Confirmation (100% specific and 100% sensitive)
99.9% specificity.
Test specificity this high ensures that almost all the people who are not infected get a negative test result with the Sensiva React Rapid Covid-19 Testing Kit. Using a fast and accurate test such as this one is vital when we are trying to stop virus transmission and protect general health.
98.7% sensitivity
Test sensitivity refers to the percentage of infected people who get a positive test result. In our case that means that 98.7% of people with an infection get a positive test result.
How to use it?
Step 1 â?? Do the test
Sensiva React Rapid Test is a simple test that can be� easily done at home. It is convenient and� painless� since it requires you to collect a saliva sample instead of a nasal swab. How to do it? First, use the mobile application to scan the QR code to register. After that, collect a saliva sample and add it into the saliva hole in the reader device before adding the liquid solution. You will be able to interpret your� results in under 2 minutes. Watch a video with detailed instructions on how to do the test in the video below. Please follow the instructions carefully to obtain a valid test result.
Step 2 â?? Get RT-PCR confirmation in 24 hours
You can use the prepaid shipping label and send the saliva sample used for the rapid test to us. You will get an official PCR result (100% sensitivity and 100% specificity) in 24 hours. Our lab is certified under the Clinical Laboratory Improvement Amendments (CLIA), so you can rely on us to provide you with accurate and reliable test results.
Who is Sensiva React Rapid Covid-19 Test for?
Sensiva React Rapid Covid-19 Test is designed for patients with COVID-19 symptoms or those who are asymptomatic but suspected of having exposure. Its easy-to-follow instructions make it convenient for testing at home.
The kit contains:
(1) Specimen Tube
(1) Saliva Funnel
(1) Dropper
(1) Bio-hazard bag with absorbent pad
(1) Lateral flow device
(1) 5ml EZ-Tear Saline Solution
(1) 0.3ml EZ-Tear Buffer Solution
(1) Written Instruction Card
Specification: 50T/kit or 100T/kit vial; 48T/kit or 96T/kit 0.1mL 8 strips/0.2mL 8 strips.
Canine distemper virus(CDV) is caused by a single-stranded RNA virus of the family . The disease is highly contagious via inhalation. The distemper virus real time PCR detection kit is intended for the qualitative detection of Canine distemper virus in samples by using real time PCR systems.
Sample Types :
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
Controls :
Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results
Product Information
Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.
Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.
About Emergency Use Authorization
(EUA)
This test (1) has not been FDA cleared or approved, (2) has been authorized by
FDA under an EUA for use by authorized laboratories, (3) has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.
The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal
aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C.
263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status. The agent detected may not be
the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization.
PRINCIPLE OF DETECTION
This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will
be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N
gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel.
dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products.
Internal reference is used in the kit for quality control starting from sample collection
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper
and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high
complexity tests.
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
Commodity: Covid-19 RT-PCR Detection Kit
Spec.96 tests/kit
Price:FOB SHANGHAI USD3.30/test, USD316.8/kit
$3.60/TEST CIF NY AIRPORT OR OTHER MAJOR AIRPORTS USA OR EUROPE OR S. AMERICA OR MIDDLE EAST
Payment: T/T ADVANCE 50% BALANCE BEFORE DEPARTURE OR Sight Irrevocable TRANSFERABLE LC Delivery: By AIR, 50days after receipt and confirmation of LC
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.
RT-PCR direct Detection Kit is intended to be used to achieve direct detection of Severe acute respiratory syndrome coronavirus 2 viral RNA from nasal swabs, nasopharyngeal swabs and oropharyngeal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. This product provides dual-detections of two independent genes of a single tube. gene and N gene is amplified and detected in FAM and HEX channel, respectively. An internal control is set with a Cy5 labeled probe using the RNase P gene of human as the target, to monitor the amplification effect of the detection system.
Our nucleic acid detection reagent can be transported at room temperature by freeze-drying technology, and can be stored at low temperature for a long time for one and a half years, and maintain good effectiveness.
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