Status COVID-19/Flu A&B POC Test Kit (Pack of 25 tests)

Description

• A rapid immunoassay for the simultaneous direct detection and differential diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens
• Anterior nasal swab specimen
• Flu A – Sensitivity 91.4%, Specificity 95.7%
• Flu B – Sensitivity 87.6%, Specificity 95.9%
• FDA Emergency Use Authorization (EUA)
• Visually read in 15 minutes
• Flocked nasopharyngeal swab for superior specimen collection and patient comfort
• Fact sheet for Healthcare providers HERE
• Fact sheet for Patients HERE
• CLIA Number Required

Contents Include:

• Status COVID-19/Flu A&B test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV-2. The device is individually pouched.
• Extraction Reagent in capsules (25): For use with swab specimens; 300 µL of Phosphate buffer with detergents and preservative
• Sterile Swabs (25): For swab specimen collection
• Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid protein)
• Negative Control Swab (1): Inactivated Group B Streptococcus antigen (non-infective)
• Package Insert /Instructions for use (1)
• Quick Reference Instructions (1)
• Materials Required, But Not Provided
  • Timer

Using Status COVID-19/Flu A&B POC Tests

1. Tear the tab off the extraction reagent capsule and dispense entire contents into the extraction well.
   • Nasopharyngeal Swab Specimen Collection:
     • Gently and slowly insert a minitip swab with a flexible shaft through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril, indicating contact with the nasopharynx.
     • Leave swab in place for several seconds to absorb secretions.
     • Slowly remove swab while rotation.
   • Anterior Nasal Swab Specimen Collection:
     • Use a flocked swab provided in the kit and insert the entire soft end of the swab into the nostril no more than 3/4 of an inch (1.5cm) into the nose.
     • Slowly rotate the swab, gently pressing against the inside of the nostril at least 4 times for a total of 15 seconds.
     • Get as much secretion as possible on on the soft end of the swab. Gently remove the swab.
2. Insert the specimen swab in the swab stand.
   • Rotate swab 3 times to mix the specimen
   • Let stand 1 minute
   • Rotate swab 3 times again and discard the swab
3. Raise the device upright and let stand 1-2 seconds.
   • Gently tap the device to ensure the liquid flows into the hole.
   • Lay the device back down
   • Set a timer for 15 minutes
4. Read test results at 15 minutes.

NOTE: False positive or false negative results can occur if the test is not read between 15 and 20 minutes.

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Status COVID-19/Flu A&B POC Tests for Sale Online

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This is one of the first combo tests for flu and COVID-19. By training, I am a microbiologist and infectious disease epidemiologist. Thus, I ordered some of these new tests to see how well they worked and how easy they were. As additional background, I have run infectious disease laboratories and have designed diagnostic assays. Thus, having an at-home test is always a nice luxury.

The instructions were easy to use. I will note that when you put the vial in the reader, do not push it all the way down, as that is when the test will actually start. So be sure to mix your swab in the buffer (purple liquid) for the appropriate time and then cap the viral and push down.

I ran the first test (far left in the picture) and within 10 minutes it came up as positive for influenza B. Currently, in the US, in my age bracket, flu B makes up about 17% of diagnosed cases, so the biological rationale is that this could be real. However, I was asymptomatic and was only running the test to see how easy it was to run. I then retested on a rapid antigen test that included SARS-CoV-2, Flu A, Flu B, and RSV. These unfortunately are not available in the US but I had some left over from a trip to Europe. That was negative for all of those pathogens. Since these molecular tests have a lower limit of detection (meaning they can detect small amounts of viral nucleic acid compared to rapid antigen tests). However I did buy four of the Lucira tests, so I ran another one (far right in the photo). That came back negative for all of the pathogens.

This is highly concerning. Given no diagnostic test is perfect, had I only had one test on hand and no way to corroborate the first test result I would have been isolating thinking that I had influenza B. When in actuality, it seems most likely that the first test was a false positive result. Looking at the Instructions for Use on the FDA website, it shows for Flu B, that in 364 PCR negative samples, 1 was positive on the Lucira test. So there is always a possibility that you test results may not be accurate. However, it was curious that this happened the first time I used this assay.

I would personally avoid this product. I have been using many of the at-home tests for the past few years and have NEVER had a false positive. Thus, this has put much doubt into the results and the technology behind this product. This is the only molecular combo assay for SARS-CoV-2 and Flu on the market at this point, but others will be released shortly and I would interpret these results carefully. Really, I would love if they refunded me the cost of one test, but I won't hold my breath there.

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