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CareStart™ COVID-19 Antigen Rapid Point-of-Care Test
Results in 10 Minutes

For businesses, organizations, nursing homes, small clinics, schools, and more.

How Can Antigen Testing for COVID-19 Protect your U.S. Business?

Fast, on-site testing is essential to protecting your workforce by offering the rapid and accurate answers you need. DDC is pleased to offer one of the select few rapid point-of-care antigen tests under EUA (Emergency Use Authorization) for use in the United States. The antigen for SARS-CoV-2 is detectable within 5 days of onset of symptoms, and so rapid diagnosis can help healthcare professionals to treat patients and control the disease more efficiently and effectively.

On-site results are ready in 10 minutes. 

Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen

  • FDA Emergency Use Authorization (EUA)
  • Determines antigens specific to SARS-CoV-2
  • Identifies lack of antigens with 100% specificity and is 88.4% sensitive for positive infections

Positive test results: Indicate the presence of viral antigens; these results should be correlated with patient history and confirmed with a lab-based PCR test.
Negative results:  May not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient-management decisions.

  • Fast results in just 10 minutes
  • Nasopharyngeal swab sample
  • Lateral-flow assay
  • Stand-alone kit
  • Sold in packs of 20
  • Test to be performed in a CLIA moderate- or high-complexity setting *

This test has been authorized only for the presence of SARS-CoV-2 antigens, and not for any other viruses or pathogens.

– This test has not been FDA cleared or approved
– This test has been authorized by FDA under an EUA for use by authorized laboratories
– This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and
– This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations.

To request more information about the CareStart™ COVID-19 Antigen Rapid Point-of-Care Test, complete the form and submit it to DDC. One of our COVID experts will contact you as soon as possible to discuss your options.

Symptoms of COVID-19

Symptoms of COVID-19 can vary from mild to severe; those infected may present all or a combination of the most common symptoms below, although it is also possible to have COVID-19 with no symptoms at all. The typical symptoms of COVID-19 are present in other illnesses as well, which is why testing is essential. 

  • Cough
  • Fever or chills
  • Shortness of breath or difficulty breathing
  • Muscle or body aches
  • Sore throat
  • New loss of taste or smell
  • Diarrhea
  • Headache
  • Fatigue
  • Nausea or vomiting
  • Congestion or runny nose

Is a Fever Always a Symptom of COVID-19?

Many places of business, events, and venues have adopted the practice of checking people for fever before they are allowed to enter. Although this is a wise strategy, it is not foolproof. According to medical authorities, it is possible to not exhibit a fever at all with coronavirus infection. Only testing can help to definitively identify or rule out an infection.

DDC Offers Two Lab-Based Tests that Determine Current COVID Infection

  1. Learn about the DDC PCR COVID-19 saliva test to determine active infection
  2. Learn about the DDC PCR COVID-19 swab test to determine active infection

COVID-19 On-Site Lateral-flow Assay Antigen Test

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 swab specimens directly collected, or collected in BD universal transport media,
from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. 10-minute on-site results do not require sending specimens to a lab.

Product Facts:

  • Store the test kit as packaged between 1 ~ 30°C.
  • The reagents and materials in the CareStart™ COVID-19 Antigen are stable until the  expiration date printed on the outer packaging.
  • Do not use beyond the expiration date.
  • The test device must remain in the sealed pouch until use.
  • Do not freeze any contents of the kit.

More detailed results of ongoing clinical evaluations and test stability report for this coronavirus test kit are available upon request.

Performance Characteristics

Clinical Performance

To initially evaluate the clinical performance of the CareStart™ 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 CareStart™ COVID-19 Antigen as compared to the RT-PCR comparator method are presented in the table below:

Clinical Study

The clinical performance characteristics of CareStart™ 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.

Analytical Sensitivity: Limit of Detection (LoD)

The LoD for direct swab was established using heat-inactivated SARS-CoV-2 isolate USAWA1/2020 (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 twofold 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.

COVID-19 IgG/IgM Rapid Test Cassette

Instructions for use

Interpretation of Results

NOTE: The test results should be read and interpreted at 10 minutes after the sample
application and the reading and interpretation of the results should not exceed 15 minutes.
The test results should not be interpreted using any instruments.

Positive: two distinct colored lines appear.
One red-colored line next to “C” and one blue-colored
line next to “T” indicates COVID-19 positive result.

NOTE: The color intensity in the test region will vary depending on the amount
of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint
colored line(s) in the test region(s) should be considered as positive.

Negative: One red-colored line only next to “C” indicates a negative
result.

Invalid:
If the red-colored line in the control region “C” is not
visible, the result is invalid. Re-run the test one time using
the remaining specimen in the extraction vial if an invalid
result is obtained during initial testing.

Limitations
1. False negative results may occur in patients who have indicated or whose clinical status or
history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
2. Negative results, should be treated as presumptive and confirmation with a molecular assay,
if necessary for patient management, may be performed.

Limitations:

  1. False negative results may occur in patients who have indicated or whose clinical status or
    history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
    levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
  2. Negative results, should be treated as presumptive and confirmation with a molecular assay,
    if necessary for patient management, may be performed.
  3. Failure to follow the instructions for use may adversely affect test performance and/or
    invalidate the test result.
  4. If the differentiation of specific SARS viruses and strains is needed, additional testing, in
    consultation with state or local public health departments, is required.
  5. Clinical performance using VTM was established on frozen specimens and performance may
    be different with fresh clinical specimens.
  6. Extracted specimens may be frozen at -80°C and used up to 5 days after freezing and it are
    stable for 4 hours in extraction buffer at room temperature.
  7. Results from antigen testing should not be used as the sole basis to diagnose or exclude
    SARS-CoV-2 infection or to determine infection status.
  8. This test will indicate the presence of SARS-CoV-2 nucleocapsid protein antigen in the
    specimen from both viable and non-viable SARS-CoV-2 virus. Test performance depends on
    the amount of virus (antigen) in the sample and may or may not correlate with viral culture
    results performed on the same sample.
  9. The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen
    collection, handling, storage, and preparation. Failure to observe proper procedures in any
    one of these steps can lead to incorrect results.
  10. Results from the device should be correlated with the clinical history, epidemiological data
    and other data available to the clinician evaluating the patient.
  11. This device has been evaluated for use with human specimen material only.
  12. False-negative results may occur if the concentration of the target antigen in the clinical
    specimen is below the detection limits of the device.
  13. This device is a qualitative test and does not provide information on the viral concentration
    present in the specimen.
  14. This test cannot rule out diseases caused by other bacterial or viral pathogens.
  15. The prevalence of infection will affect the test’s predictive values.
  16. Positive and negative predictive values are highly dependent on prevalence. False-negative
    test results are more likely during peak activity when the prevalence of the disease is high.
  17. False-positive test results are more likely during the periods of low SARS-CoV-2 activity
    when prevalence is moderate to low.

 

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Fairfield, OH 45014

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