Rapid COVID-19 Antibody Self Test Kits
GREAT FOR BUSINESSES
Find out if you have Covid-19 without an appointment from the convenience of your home or business!
Contains 25 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
$1,250 / box
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READY TO USE OUT OF THE BOX
|Instructions for use||1 Pamphlet|
|Test Card||25 Cassettes|
|Alcohol Wipes||25 Packets|
WATCH EASY HOW-TO VIDEO
Easy INSTRUCTIONS, results in 15 minutes
Add freshly collected specimen into the sample well on the test card. This can be done with the finger directly.
Add 2-3 drops of sample buffer into the well
Wait for 10-15min, interpret the result according to the kit instruction
INTERPRETATION OF RESULTS
understanding your test
COVID not detected.
Early stages of infection. Infectious, please quarantine and see general physician.
IgG & IgM Positive
Latter stage of infection, still contagious. Remain quarantined and see general physician.
Confirmed previously infected, quarantine not necessary. Can determine asymptomatic or not.
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.
A retrospective study was carried out with 186 samples from a local hospital during the COVID-19 pandemic, including 78 samples of other (non SARS-CoV-2-mediated) respiratory tract infections (negative for SARS-CoV-2 infection by PCR) and 108 samples of healthy people (lacking respiratory symptoms by physical examination, and negative for SARS-CoV-2 infection by PCR). All samples were tested with SARS-CoV-2 lgM/lgG antibody test kit and negative percent agreement to PCR was evaluated. The Negative Percent Agreement (NPA) of lgM and lgG are as follows:
To evaluate the performance of the SARS-CoV-2lgM/lgG antibody test kit over time with PCR positive patients, 197 serum samples were collected serially from 40 hospitalized SARS-CoV-2 PCR positive patients at different days following the onset of symptoms between 1-7, 8-14 and at least 15 days. The Positive Percent Agreement (PPA) According to Days From Onset of Symptoms:
A retrospective study was carried out with 791 samples from a local hospital. These samples could be classified into two groups, one group is 647 PCR confirmed negative samples, including 203 samples selected from patients with other respiratory tract infections, 416 samples selected from pregnant patients, and 28 samples selected from healthy people undergoing physical examination. All these 647 serum samples were collected in the Clinical Laboratory of the hospital from February to March 2020, and these patients were confirmed SARS-CoV-2 negative by PCR. The other group is samples taken prior to the COVID-19 outbreak.
All these 144 inpatients were selected from non-respiratory departments, and their serum samples were collected in the Clinical Laboratory of the hospital from May 2019 to October 2019. Negative percent agreements were evaluated in comparison to negative PCR results or pre-outbreak presumed negative status.
Negative Percent Agreement (NPA) statistics
lgM NPA = l00% x 640/647 = 98.92%; 95%CI: 97.78% to 99.56%
lgG NPA = l00% x 647/647 = 100%; 95%CI: 99.43% to 100%
Negative Percent Agreement (NPA) statistics
lgM NPA = 100% x 144/144 = 100%; 95%CI: 97.47% to 100%
lgG NPA = 100% x 144/144 = 100%; 95%CI: 97.47% to 100%
The SARS-CoV-2 lgM/lgG Antibody Test Kit was tested on 2020-05-28 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI). The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both lgM and lgG antibodies were confirmed to be present in all 30 samples. The presence of anti-bodies in the samples was confirmed by several orthogonal methods prior to testing with the SARS-CoV-2lgM/lgG Antibody Test Kit. The presence of lgM and lgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.
All antibody-negative samples were collected prior to 2020and include i) Seventy (70) samples selected withoutregard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+” .Testing was performed by one operator using 1 lot of SARS-CoV-2 lgM/lgG Antibody Test Kit antibody tests. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
For the evaluation of cross-reactivity with HIV+, it was determined whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below:
Important limitations of study 3
- Samples were not randomly selected, and sensitivity and specificity estimates may not be indicative of the real-world performance of the device
- These results are based on serum and plasma samples only and may not be indicative of performance with other sample types, such as whole blood, including finger stick blood.
- Information about anticoagulants used is not known.
- The number of samples in the panel is a minimally viable sample size that still provides reasonable estimates and confidence intervals for test performance, and the samples used may not be representative of the antibody profile observed in patient populations.
The SARS-CoV-2 lgM/lgG Antibody Test is based on the immunochromatographic method. The SARS-CoV-2 lgM/lgG is detected by SARS-CoV-2 recombinant N-protein antigen and mouse anti human lgM/lgG antibody. SARS-CoV-2 lgM/lgG inthe sample reacts with SARS-CoV-2 recombinant N-protein antigenbound to gold particles. This complex migrates along the membrane and reaches the lgM/lgG test line (T) which contains mouse anti human lgM/lgG antibody against SARS-CoV-2 lgM/lgG complex. The sample diluent is supplied for the lateral chromatography process, to provide a suitable environment for the reaction of antigen and antibody.
When the result is positive, the gold-labelled SARS-CoV-2 recombinant antigen-antibody complex binds to the lgM/lgG test line (T) and a purplishredcolor develops. When the result is negative, the sample does not contain any SARS-CoV-2 recombinant N-protein antigen-antibody complex that can bind to the lgM/lgG test line (T) so no color becomes visible. Development of a purplishred control line(C) helps ensure the addition of sufficient specimen volume and adequate migration have occurred and that the test was properly performed.
Cross-reactivity of the SARS-CoV-2 lgM/lgG Antibody Test was evaluated by using clinical serum samples containing antibodies to the underlying conditions listed below. Five samples with antibodies to underlying conditions 1 to 7, and 20 samples with antibodies to conditions 8 to 12, were tested in singlicate with three separate lots of this SARS-CoV-2 lgM/lgG antibody test. None of the antibodies to the listed underlying conditions cross-reacted with this SARS-CoV-2 lgM/lgG antibody test kit to generate false positive results.
- Anti-influenza A (lgG and lgM)
- Anti-influenza B (lgG and lgM)
- Anti-HCV (lgG and lgM)
- Anti-HBV (lgG and lgM)
- Anti-respiratory syncytial virus (lgG and lgM)
- Anti-Haemophilus influenzae (lgG and lgM)
- Anti-229E (alpha coronavirus) lgG
- Anti-NL63 (alpha coronavirus) lgG
- Anti-OC43 (beta coronavirus) lgG
- Anti-HKUl (beta coronavirus) lgG
- Anti-rhinovirus lgG
One set of sample diluent, serum, plasma (heparin,K2-EDTA, and sodium citrate), and venous whole blood (heparin, K2-EDTA, and sodium citrate) samples positive for SARS-CoV-2 lgM/lgG antibodies, and another set of serum,plasma (heparin, K2-EDTA, and sodium citrate), and venouswhole blood (heparin, K2-EDTA, and sodium citrate) samples negative for SARS-CoV-2 lgM/lgG antibodies were prepared. Both sets were spiked with one of the following substances at the concentrations specified below, and tested in multiple replicates. No false positive or false negative results were found with the following substances:
- Purified mucin (60 g/L)
- Bilirubin (342 μmol/L)
- Triglyceride (37 mmol/L)
- Hemoglobin (2 g/L)
- Rheumatoid factor (30 IU/mL)
- HAMA (25 mg/mL)
- ⍺ – interferon (40 ng/ml)
- Zanamivir (10 μg/L)
- Ribavirin (20 mg/mL)
- Oseltamivir (250 μg/L)
- Peramivir (30 mg/L)
- Lopinavir (12 mg/L)
- Ritonavir (12.5 mg/L)
- Abidor (10 μg/mL)
- Levofloxacin (25 mg/L)
- Azithromycin (25 mg/mL)
- Ceftriaxone (10 μg/mL)
- Meropenem (3.3 mg/mL)
- Tobramycin (125 mg/L)
- Histamine hydrochloride (50 mg/L)
When the body is infected with COVID-19, the specific protein of the virus stimulates the immune system and leads to an antibody response. The first antibody to appear is IgM, and then the IgG antibody.
From the general process of acute infection, when the IgG antibody appears, the concentration will continue to increase as the IgM antibody will decrease or even disappear. The IgG antibody will exist for a long time. The simultaneous dynamic monitoring of IgM and IgG antibody can be used in the auxillary diagnosis of a COVID-19 infection.
Our test is confirmed by Yale University & Yale New Haven Hospital for patients tested at least 2 weeks from symptom onset.
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
Our test kit specificity and sensitivity numbers are confirmed by Yale University & Yale New Haven Hospital for patients tested at least 2 weeks from symptom onset. Please review the study and the methodology by clicking the link below:
Applicable to human serum, plasma (heparin, di potassium (K2)-EDTA, and sodium citrate), and venous wholeblood (heparin, K2-EDTA, and sodium citrate) samples.
For whole blood: For whole blood, collect blood specimen into acollection tube (containing heparin, EDTA or Citrate) by veni-puncture. The anticoagulative whole blood sample shouldnot be stored for more than 6 hours at normal temperature(18-30°C). The sample should not be stored for more than 1day at 2-8°C, do not freeze whole blood specimens.
For serum and plasma (heparin, K2-EDTA, and sodium citrate) samples: The samples should be tested immediately after collection. Serum and plasma (heparin, K2-EDTA, and sodium citrate) samples can be stored for 5 days at 2-8°C. If long-term storage is required, it should be stored at -20°C (It has been confirmed that the sample can be stored for 3 months at -20°C}. Serum or plasma specimens can be subjected to a maximum of 3 freezing/thawing cycles.
Let the samples reach room temperature and mix well before testing. When there are visible particles in the sample, it should be centrifuged before the test to remove the precipitate.
If there is a lot of lipid (Triglyceride concentration over 37 mmol/L), hemolysis or turbidity in the sample, please do not use the sample to avoid affecting the result interpretation.
- Sample vortex mixer
- 10-100μ1 pipette and tips
- Test tubes
- Sample collection tubes
- External positive controls for IgG and IgM antibodies & Negative control
DR. REYES' TESTIMONY
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