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
AccuPowe COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections, detects SARS-CoV-2 (E gene and RdRp gene) RNA from a suspected infection patient's sample (such as sputum, nasopharyngeal swab, oropharyngeal swab) through Real-Time Polymerase chain reaction(PCR) using ExiStation Universal MDx system.
Validated to:
Bio-Rad CFX96
ABI 7500 Fast
Target Genes: Rdrp, E
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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.
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
Our test kit has been approved and endorsed by Singapore's MOH (Ministry of Health) and HSA (Health Science Authority) since last year and we have been constantly supplying to the APAC countries during this period. (Japan, India, Singapore, Malaysia, Indonesia and etc.)
* CE mark was attained in December 2020. *
Our Tepat 1.0 SARS-CoV-2 RT-PCR provides for high-throughput, sensitive and specific detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs*.
It can detect 6 copies of viral RNA per reaction with > 95% confidence. Clinical validation shows 100% sensitivity, with no cross-reaction with non-SARS-CoV-2 species.
Key Highlights
1.5 hours from RNA to results
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
100% coverage with 100% identity of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA
Whole process control: human RNase P
Product Details:
Number of Reactions(Preps) per Kit : 100
Brand : Seegene
ICMR(Govt) Approved : Yes
Test Method : (SARS-CoV-2) RT-PCR
Test Time : 2 Hours
Cat. No : RP10243X
-Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient work ow on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer
Cat No : RP10243X. Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient work now on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer.
COVID-19 RT-PCR TEST - NO RNA PURIFICATION NEEDED!
Results in less than 60 minutes, very easy-to-use.
Made in USA, with clinical validations all over the world.
FDA-EUA approved and CE cleared.
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.
- In vitro diagnostics(IVD) Kits
- Designed for the qualitative detection of COVID-19 viral RNA
- Oropharyngeal swab, nasopharyngeal swab, sputum and bronchoalveolar lavage (BAL)
- Store at -25~ -15
Product description:
Detects the novel coronavirus.
COVID-19 using one-step real-time RT-PCR in a single tube.
The target genes for the detection of the virus are Orf1ab and N gene.
The sequence of primers and probes for the amplification were adapted from sources published by China CDC and WHO.
The kit includes primers and probe for the amplification of the human RNase P gene that serves as an internal positive control for the real-time RT-PCR.
Compatible real-time PCR machines: CFX96(Bio-Rad), ABI 7500/7500Fast(Thermo Fisher Scientific), SLAN-96S(Hongshi), Rotor-Gene Q(QIAGEN)
RT PCR TEST KITS FOR COVID ARE AVAILABLE DIRECTLY FROM MANUFACTURERS IN SOUTH KOREA.
No intermediaries.
Please contact For quotes only if you are a buyer.
