The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
This test has been authorized by the FDA under a EUA for professional use CLIA and CLIA WAIVED for Point Of Care.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This product is intended for professional use and not for home use.
FACT SHEET FOR HEALTHCARE PROVIDERS
This test has been authorized by the FDA under a EUA for use by authorized CLIA laboratories. This device is CLIA waived for point of care use for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
There should be a blue line in the control region (next to ) before testing, discard the device if there is no blue line.
For in vitro qualitative detect of Covid-19 antigen in nasal(NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of the symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
1.Easy to collect samples simple operation without professional equipment.
2.The test results are available in 15 minutes, and the test results are clearly visible. 3.Convenient transportation and low price, higher accuracy.
4.Suitable for large-scale rapid screening.
Shelf life: 24 Months
Test Result time: 10 Mins
Packing: 25 Pieces per Box
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
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.
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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
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).
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.
European CE Certified
15 Minutes Detection Time
Format 25T/Kit
Colloidal Gold Method
Detection Substance: Antibody
Type of Sample : Serum/Plasma/Whole Blood
No instruments needed
Rapid Accurate Innovative Comfortable Lollipop style Integral
This SARS-CoV-2 Antigen Kit (Saliva Pen) is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in saliva specimens from individuals who are suspected of COVID-19.
The most suitable for over-the-counter (OTC) home use by laymen in a non-laboratory setting.
The most widely used testing scenarios, like for school kids test.
The most integral design, simple and easy use lollipop style.
The fastest result deliver: result is available within only 15 minutes.
Pathodetect 2019- nCov Detectioin kit offer an in virto diagnostic real time PCR assay for qualitative detection of 2019 - Novel Coronavirus RNA in respiratory specimens and sera. The kit offer the universal detection of SARS- Like coronavirus and specific detection of 2019-nCOv.
Mylab Discovery solutions 2019-nCoV Detection Kit provides ready to use solution for detection of coronavirus using real time PCR technology. Detection is based on the amplification of a specific conserved RNA sequences of coronavirus and detection by Taqman probe-based chemistry. An Internal control is detected along with the coronavirus target controlling the extraction efficacy and possible PCR inhibition. The test is designed to use across wide range of PCR platforms. The recommended CDC protocol for coronavirus detection ensures that the kit leads to highly-specific and ultrasensitive results in short time.
KIT CONTENTS
Reagents for Nucleic acid extraction from respiratory/sera specimens
Reagents for Real time PCR
Inclusion of synthetic positive and negative controls
The COVID-19Antigen Rapid Test Cassette (Saliva) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from individuals who are suspecte of COVID-19 by their healthcare provider. There are single pack and 25pcs products (SOFTEC COVID-19 Antigen Rapid Test (Saliva)25pcs Pack).
The price of the product is determined by the number of orders.
SOFTEC COVID-19 Antigen Rapid Test (Nasal)
The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV 2 nucleocapsid antigens in nasal swabs from individuals with suspected COVID-19 by health care providers. Results are for SARS-CoV-2 nucleocapsid antigen identification. The COVID 19 Antigen Rapid Test Cassette (Nasal Swab) is intended for use by medical professionals or trained operators experienced in performing lateral flow tests.
The price of the product is determined by the number of orders.
The PocRoc SARS-CoV-2 Antigen Rapid Test Kit (TRFIA) is an immunofluorescent sandwich assay. It can detect the virus with very high sensitivity and specificity.
When the sample is applied to the sample wells, SARS-CoV N protein and labeled antibody complexes are formed and travel up the strip. The labeled microsphere fluorescent probe reagent is used to form a visible red line with a matched UV flashlight.
The presence of SARS-CoV-2 will be indicated by a visible red test line (T) in the result window. The membrane is pre-coated with Chicken IgY on the control (C) line. Control (C) line appears in each result window when the sample has flowed through the strip.
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