Due to contractual obligations to the federal government, Current suppliers have increased costs and limited production of all point of care tests without notice. We have great news! To shield our customers from excessive price increases as well as provide immediate availability, we have secured multiple FDA EUA rapid antigen test kit options. These tests have similar and/or better accuracy along with individual buffer bottles. We are currently able to provide three options: Clarity-Sienna, Indicaid and Celltrion DiaTrust kits. We work directly with the distributor and can supply by the pallet or case with pricing as low as $6.00 per kit.
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
The 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.
About Test Device
Gives Positive or Negative Result for COVID-19 IgM/IgG antibodies
Read Results in 15 Minutes
Contents of each box
STANDARD M nCoV Real-Time Detection kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples.
- One tube reaction for identification and detection of 2019-nCoV
- One-step Real-Time RT-PCR
- Provide all reagents required for PCR
- Designed according to WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans"
- nCoV primers/probes ORF1ab (RdRp) gene, E gene
Provide Internal controls
Kindly check ghope-ppe.com. All information is for a consumer. If you want to buy a bulk, please contact us.
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Designed for qualitative detection of SARS-CoV-2 antibodies in human serum, plasma, and whole blood samples, novel coronavirus antibody detection reagent (Colloidal Gold Method) is regarded as auxiliary detection metrics towards on-site screening for suspected cases that have the negative results after nucleic acid testing. This rapid test can aid in the diagnosis of coronavirus infection and significantly shorten the detection time, yielding the results in 15 minutes.
1. Generic Name: Novel Coronavirus COVID-19 IgG Antigen Test Kit
2. Brand Name: NIL
3. Notified Category: Other than above substances intended for qualitative determination of COVID-19 infection
4. Class of Medical Device: Class D
5. Shelf life :15 months
6. Sterile/Non-Sterile: Non-Sterilized
7. Contains Drugs: No
8. Medical Device Grouping Category: IVD-Kit
9. Grouping Description: Intended for qualitative determination of COVID-19 infection
10. Intended Use: The Novel Coronavirus COVID-19 IgG Kit is intended for the qualitative detection of human anti-COVID- 19 IgG antibody in human serum/plasma. Any reactive specimen with the Novel Coronavirus COVID-19 IgG Kit must be confirmed with alternative testing method(s).
11. Product Description: Assay controls and 1:10 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length recombinant protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen-human anti-COVID-19 IgG antibody - HRP labeled anti human IgG tracer antibody" is formed if there is specific Coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP-Labeled tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen.
SALIENT FEATURES:
â?¢ Recombinant COVID-19 Spike subunit Protein coated on Microwell Plate
â?¢ HRP Conjugated Polyvalent Anti-Human IgG
â?¢ Assay Time: 80 mins (30mins+30 Mins+20mins)
â?¢ Strip Format Microwell Plate
â?¢ Ready to use Substrate and Controls
â?¢ Only 20 pL of human serum is required for measurement in duplicate.
â?¢ Works on any open ELISA system
â?¢ Assay procedure is easy to automate
OUR TEST:
â?¢ Principle: Indirect ELISA
â?¢ The normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 150) and RT-PCR confirmed positive patients in after the second week of the onset of the disease (n = 32). The Positive sample evaluation was done at external Approved Lab. The results are as follows:
â?¢ Diagnostic sensitivity is 100% (>98%)
â?¢ Diagnostic specificity is 98.67% (>97%)
â?¢ PPV: 94.12�°/0
â?¢ NPV: 100%
Please contact us for more information and product details.
Easy-to-use "All-in-one" test for the detection of anti SARS-CoV-2 antibodies (lgM & lgG)
The Novel Coronavirus 2019-nCoV) lgM/lgG Antibody Combo Test Kit (Colloidal Gold) is intended for the qualitative detection of the antibodies of lgM/lgG against novel coronavirus in serum, plasma, or whole blood from patients with clinical suspicion of 2019-nCoV infection
RAPID ANTIBODY/Finger Prick 10 to 15 Minute Results
An antibody test is also known as a serology test looks for the presence of antibodies, which are specific proteins made in response to infections. It is effective at detecting the recent past SARS-CoV2 infection. This test can detect the body's IgM Antibody response in as little as 7 days (IgG in 14 days) from infection with CDC validated 100% specificity and 100% sensitivity.
The highest accuracy serological test on the market
FDA EUA Approved
Manufactured by one of the leaders in lateral flow technology
COVID finger prick, rapid antigen test, or rapid test, is a rapid diagnostic test suitable for point-of-care testing that directly detects the presence or absence of an antigen. It is commonly used for the detection of SARS-CoV-2, the virus that causes COVID-19. Rapid tests are a type of lateral flow tests that detect protein, distinguishing it from other medical tests that detect antibodies or nucleic acid, of either laboratory or point-of-care types. Rapid tests generally give a result in 1 to 15 minutes, require minimal training or infrastructure, and have significant cost advantages. NO Lab Required for results.
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