Rapid COVID-19 Antigen Self Test Kits
GREAT FOR BUSINESSES
Find out if you currently have Covid-19 without an appointment from the convenience of your home or business!
Contains 20 self-administered tests
I certify that this product is for the use and sole administration of licensed medical professionals from a CLIA certified medical facility. This product is not intended for individual and/or public use and must only be administered by medical professionals
$1,000 / box
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READY TO USE OUT OF THE BOX
20 tests per box
|Instructions for use||1 Pamphlet|
|Test Device||20 Tests|
|Assay Buffer||20 Buffers|
|Extraction vials and caps||20 Vials & Caps|
|Specimen collection swabs||20 Swabs|
|Positive control swab||1 Swab|
|Negative control swab||1 Swab|
Easy INSTRUCTIONS, results in 10 minutes
Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times
Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
INTERPRETATION OF RESULTS
understanding your test
COVID not detected.
Early stages of infection. Infectious, please quarantine and see general physician.
Latter stage of infection, still contagious. Remain quarantined and see general physician.
Stay active. Keep testing.
Our test kit is a lateral-flow assay that uses colloidal gold SARS-CoV-2 recombinant antigen-antibody complexes to identify IgG/IgM Antibodies in the blood. It produces results in 15 minutes with 99% specificity and 95% sensitivity.
Suitable for suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact with infected patients and people under quarantine control.
To initially evaluate the clinical performance of the Sethi Laboratories COVID-19 Antigen test, a total of 126 blinded frozen swab samples, including 106 retrospective clinical specimens and 20 contrived specimens, were tested in one (1) CLIA waived investigational site by five (5) minimally trained operators in the U.S during the 2020 COVID-19 season.
A total of 126 frozen samples consisting of 43 positive nasopharyngeal (NP) swabs, 63 negative NP swab specimens, and 20 contrived near the cut-off samples (10 positives and 10 negatives). NP swab specimens collected from the patients with COVID-19 like symptoms in the U.S during the 2020 COVID-19 season and stored in BD universal transport media tube were provided by multiple vendors in the U.S. All the NP swab specimens were confirmed as positive or negative and validated with Ct value by the FDA EUA RT-PCR as a comparator method prior to the study. The specimens were aliquoted, randomized, and blinded into sample panels that was tested by each operator, using the instructions provided by the Quick Reference Instructions (QRI).
In addition to the clinical population, a total of 20 contrived near the cut-off samples, 10 low positives near the Limit of Detection (LoD) (2x LoD), and 10 negatives (zero analytes) samples, were prepared using the inactivated SARS-CoV-2 strain spiked into the simulated nasal swab matrix, BD universal transport media. The heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 was used to prepare the positive samples. The contrived near the cut-off samples were added to the clinical population and tested at the same study site by the same operators. All the study samples were randomized and assigned with unique study subject ID by the sponsor prior to testing at the study site. The expected results of the samples were completely blinded to the operators. All the samples were tested by five (5) operators according to the Quick Reference Instructions only.
A total of 126 frozen swab samples were considered evaluable in this study. The performance of the Sethi Laboratories COVID-19 Antigen as compared to the RT-PCR comparator method are presented in the table below:
Sethi Laboratories COVID-19 Antigen (retrospective samples) Performance against the Comparator Method
Sethi Laboratories COVID-19 Antigen (near the cut-off samples) Performance
The clinical performance characteristics of Sethi Laboratories COVID-19 Antigen test is currently being evaluated in a multi-site prospective study in the U.S in which NP swabs from patients are sequentially enrolled and tested. A total of five (5) investigational sites throughout the U.S are participating in the study. Testing is performed by operators with no laboratory experience and who are representative of the intended users. Operators are only using the QRI for the test without any training provided. The patients presenting the COVID-19 like symptoms within five (5) days of symptom onset at the study sites are enrolled. An FDA EUA RT-PCR assay for the detection of SARS-CoV-2 from a NP or nasal swab is utilized as the comparator method for the study. The initial six (6) positive patient results are presented as below.
Sethi Laboratories COVID-19 Antigen Initial Performance against the Comparator Method
The LoD for direct swab was established using heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 (NR-52286). The strain was spiked into the pooled human nasal swab matrix obtained from multiple healthy volunteers eluted in VTM and confirmed as SARS-CoV-2 negative by RT-PCR to prepare positive samples. The estimated LoD found from the initial two-fold serial dilution test was confirmed by testing 20 replicates. The confirmed LoD for direct swab was 8 x 102 TCID50/ml.
The LoD for swab in VTM (BD universal transport media) was established using heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 (NR-52286). The two-fold serial diluted strain stocks were spiked into each of 3 ml human nasal swab matrix obtained from multiple healthy volunteers eluted in 3 ml VTM tube. The estimated LoD found from the initial two-fold serial dilution test was confirmed by testing 20 replicates. The confirmed LoD for swab in VTM was 6.4 x 103 TCID50/ml.
The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with SARS-CoV-2 negative samples using the Sethi Laboratories COVID-19 Antigen test. Potential microbial interference was evaluated with samples containing heat-inactivated SARS-CoV-2 isolate USA-WA1/2020 at approximately 3x LoD. A total of 8 bacteria were tested at a target concentration of approximately 107 cfu/ml with the exception of Mycoplasma pneumoniae, which was tested at a final concentration of 1.5 x 103 cfu/ml. The 18 viruses were tested at concentrations between 105.2 and 107.9 TCID50/ml. All negative samples gave negative results at the concentrations of the potentially cross-reactive common organisms tested showing no cross-reactivity with Sethi Laboratories COVID-19 Antigen assay. All samples with SARS-CoV-2 strain tested positive showing no microbial interference at the concentrations of the potentially interfering common organisms tested.
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not available for wet testing, in silico analysis using the Basic Local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology.
• The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus HKU1 nucleocapsid protein is relatively low, at 36.7% across 86.4% of sequences, but cross-reactivity cannot be ruled out.
• The homology between SARS-CoV-2 nucleocapsid protein and Mycobacterium tuberculosis total protein (3,991 proteins) is relatively low, homology-based cross-reactivity can be ruled out.
• The homology between SARS-CoV-2 nucleocapsid protein and Pneumocystis jirovecii total protein (3,745 proteins) is relatively low, homology-based cross-reactivity can be ruled out.•The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus 229E nucleocapsid protein is relatively low, at 28.8% across 72.1% of sequences, but cross-reactivity cannot be ruled out. However, a result of the cross-reactivity wet study showed that CareStart™ COVID-19 Antigen had no cross-reactivity against human coronavirus 229E.
• No homologous protein was detected as a result of in silico assay with all the proteins (686proteins) of Mycoplasma pneumoniae and the nucleocapsid protein (NP) of SARS-CoV-2. So, cross-reactivity of CareStart™ COVID-19 Antigen against Mycoplasma pneumoniae can be ruled out.
To assess substances with the potential to interfere with the performance of the Sethi Laboratories COVID-19 Antigen, positive and negative samples were tested with the addition of potentially interfering substances. The SARS-CoV-2 target concentration in the positive samples was approximately 2x LoD. All samples tested produced expected results, demonstrating that the Sethi Laboratories COVID-19 Antigen test performance was not affected by any of the 30 potentially interfering substances listed in the table below at the concentrations tested.
The interfering effects of biotin concentrations ranging between 625 ng/mL and 10 μg/mL were tested in a separate study. Biotin concentrations up to 1.25 μg/ml did not lead to false results. Biotin concentrations ≥2.5 μg/ml can cause false-negative COVID-19 results with the Sethi Laboratories COVID-19 Antigen.
No. This test is not yet approved or cleared by the United States FDA.
When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).
The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s ) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).
If you have a positive test result, it is very likely that you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease.
There is a very small chance that this test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample.
However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If your test result is negative, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay.
It is important that you work with your healthcare provider to help you understand the next steps you should take.
There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection.
If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you do not have an additional test to determine if you are infected and may spread the infection to others, the CDC currently recommends that you should stay home until three things have happened:
• You have had no fever for at least 24 hours (that is one full days of no fever without the use of medicine that reduces fevers)
• Other symptoms have improved (for example, when your cough or shortness of breath has improved)
• At least 10 days have passed since your symptoms first appeared.
Potential risks include:
• Possible discomfort or other complications that can happen during sample collection.
• Possible incorrect test result (see below for more information).
Potential benefits include:
• The results, along with other information, can help your healthcare provider make informed recommendations about your care.
• The results of this test may help limit the spread of COVID-19 to your family and others in your community
DR. REYES' TESTIMONY
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