* High Accuracy, Specificity and Sensitivity
* No need instrument, Get Results in 15 Minutes
* Room Temperature Storage
* Sample: Saliva Sample
* Detect the presence of viral proteins
* Identify acute or early infection
1 Test/Kit
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For the qualitative assessment of COVID-19(SARS-CoV-2) neutralizing antibody after the vaccination in human serum/plasma/whole blood.
Sensitivity: 95.39%
Specificity: >99.9%
Accuracy: 98.47%
CE Certificate available.
40981 Covid 19 Diagnostic Kit Suppliers
Short on time? Let Covid 19 Diagnostic Kit sellers contact you.
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.
Indication:
Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
About Test Device
EUA Authorized
CE Mark
Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection.
Read Results in 15 Minutes
9 Month Expiration from Date of Manufacture
Contents
The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Lateral flow assay
Detect SARS-CoV-2 nucleocapsid protein antigen
Rapid results within 10-15 minutes
Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
For use with direct anterior nasal and nasopharyngeal swab specimens
Clinical Performance
93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
87.18% PPAa and 100% NPAb when used with anterior nasal swab
I am representing SD Biosensor from South Korea that manufactures US FDA EUA approved Standard M nCo V Real-Time Detection Kit (COVID Testing kit). We have received US FDA EUA approval to export Covid 19 detection kit in April and can directly export from Korea.
SD Biosensor is one of the few companies that has received US FDA approvals and have already sold 1.5 million testing units to US government (Based on US government reaching out to South Korea Government for help with procuring Covid Testing kits).
I'm currently in Seoul, South Korea but I'm a US citizen helping SD Biosensor as an agent to help buyers procure these testing kits. This company has capability to manufacture over 600,000 testing units a day and have enough supplies readily available for an immediate export.
Please email me at Jinsoo.park@yahoo.com to receive US FDA EUA Approval and product information. rapid test kits which are not FDA approved are in the low to mid $20 range and the price for FDA EUA approved standard test kits are around high $20s to low $30s and depending on the contract length and quantity we have some room for negotiation. Also these kits have to be refrigerated shipped so there will be some additional cost for this.
The NeoPlexTM COVID-19 Detection Kit Assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from respiratory specimens* obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The NeoPlexTM COVID-19 Detection Kit is for use only under Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.�§263a, to perform high complexity tests.
SARS-CoV-2 Antigen Detection Kit
For Nasal Swab, home testing
Colloidal Gold Method
Package Available: 1 Test/box, 5 Tests/box, 10 Tests/box, 20 Tests/box
Carton Size: 63 x 39 x39cm
Price is different based on QTY from 10K to 500K or above
Payment Term: T/T
Delivery time: 3-5 days
Price Valid: 30 days
Quality Warranty: 2 years.
SOFTEC COVID-19 IGG/IGM Antibody Test Kit (Single Pack)
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatograpic immunoassay for the qualitative defection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of intection with Novel coronavirus.
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).
The Rapid COVID-19 Antigen Oral Fluid Self-Test is a lateral flow test for the qualitative detection of nucleocapsid protein antigenfrom SARS-CoV-2 in oral fluid from individuals who are both symptomatic and asymptomatic.This testis intended to aid in the rapid diagnosis of Coronavirus infections. If symptoms persist despite negative test results it isrecommended to visit a healthcare professional to seek follow up care.Rapid COVID-19Antigen Oral Fluid Self-Test is intended foruse by layperson home users.
Corona Antigen Tests, single packed
On Stock in
700 000 units immediately
up to 1,2 million on the way and roll-over orders in line with producer
without engagement, subject to prior sale
