****UPDATE: AS OF 1/12/2022 OSWALD’S PHARMACY IS NO LONGER USING THE HEALGEN RAPID ANTIBODY TEST****
Information on the Accuracy of the Healgen Rapid Antibody COVID-19 Test
There are a lot of COVID-19 Antibody tests out there right now. Oswald’s Pharmacy chose the Healgen Rapid Antibody COVID-19 Test for two main reasons: accuracy and reliability. We want our patients and customers to know that all of our COVID-19 Antibody tests are being handled by CLIA lab-certified technicians using one of the most accurate COVID-19 Tests currently available.
More from the Oswald’s Pharmacy Lab Director:
“Oswald’s Pharmacy has been using the Healgen COVID-19 IgG/IgM Rapid Test Cassette for nearly 6 months. As the laboratory director, I selected this particular test for use at Oswald’s Pharmacy due to its performance characteristics over others that were available to us. Over time, it has become clear that the Healgen test is working well. The laboratory staff at Oswald’s pharmacy have achieved 100% correct result interpretation on blinded samples, which cannot be said by many other laboratories. We will continue to use the Healgen COVID-19 IgG/IgM Rapid Test Cassette for the foreseeable future“
- Brian N. Kelly, Ph.D., DABCC, FAACC
The Healgen COVID-19 Antibody Test has continually posted exceptionally accurate results since the FDA granted it Emergency Use Authorization (EUA). Further test results after EUA-authorization ranked the Healgen test among the most accurate in the industry.
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Independent COVID-19 Test Accuracy Reviews
Business Insider released an article in late July listing the Healgen Rapid Antibody COVID-19 Test as one of the best. Here are the key takeaways from the Business Insider Article:
- The top 13 antibody tests in the independent review had both high sensitivity and specificity. researchers also highlighted the 13 highest-performing antibody tests on the market. A few FDA-EUA authorized tests — from Beijing Wantai Biological Pharmacy, Healgen, and Abbott — made the cut
- The rapid test from Healgen was one of the few tests with 100% sensitivity and 100% specificity — but those results were only for IgM antibodies.
- The Healgen test for IgG antibodies had 96.7% sensitivity and 97.5% specificity. Both of the company’s test results match the percentages listed on the FDA website.
“Healgen’s antibody test, meanwhile, showed 100% sensitivity and specificity for IgM, and about 97% for IgG. Combined, the test had a positive predictive value of 67.8%, and a negative predictive value of 100%, with no HIV cross-reactivity.”
How the Healgen Rapid Antibody COVID-19 Testing Process Works at Oswald’s
1) Patient arrives for the appointment and is given a clipboard with information to fill out. Pens and clipboards are sanitized between patient use.
2) Patient enters the laboratory and sits in the lab chair while the phlebotomist prepares the test cassette. A motorized fan operates all day to ensure proper airflow in the lab.
3) A tourniquet is tied on the patient’s arm and the phlebotomist will feel for a vein.
4) Once the vein is located, the phlebotomist will clean the area with alcohol, then insert the newly-opened, sanitized needle.
5) The phlebotomist takes removes the tourniquet, the needle, and places a bandage on the venipuncture site.
6) The phlebotomist places 1 drop of blood and 2 drops of a special buffer solution into the test cassette and sets a timer for 10 minutes.
7) While the patient waits for results, the phlebotomist will sanitize the lab chair, table, and supplies the patient used to fill out their information forms.
9) The phlebotomist will then share test results with the patient. 1 line on the cassette indicates COVID-19 antibodies are NOT DETECTED. 2 lines indicate IgG antibodies are DETECTED. 3 lines indicate both IgG and IgM antibodies are DETECTED.
11) The phlebotomist will print an itemized receipt containing information and test results for the patient’s personal medical use.
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FDA Information on the Healgen Rapid Antibody COVID-19 Test
Healgen COVID-19 IgG/IgM Rapid Test Cassette
Developer: Healgen
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike
| Antibody | Performance Measure | Estimate of Performance | 95% Confidence Interval |
| IgM | Sensitivity | 100% (30/30) | (88.7%; 100%) |
| IgM | Specificity | 100% (80/80) | (95.4%; 100%) |
| IgG | Sensitivity | 96.7% (29/30) | (83.3%; 99.4%) |
| IgG | Specificity | 97.5% (78/80) | (91.3%; 99.3%) |
| Combined | Sensitivity | 100% (30/30) | (88.7%; 100%) |
| Combined | Specificity | 97.5% (78/80) | (91.3%; 99.3%) |
| Combined | PPV at prevalence = 5% | 67.8% | (35.0%; 88.4%) |
| Combined | NPV at prevalence = 5% | 100% | (99.4%; 100%) |
COVID-19 Antibody Testing at Oswald’s
We currently offer COVID-19 Antibody testing on a weekly schedule. Click here for availability and online signups. If you have any questions about the tests, results, or any part of the COVID-19 Antibody testing process, please talk to one of our lab technicians or send us an email.
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Notes from Healgen:
- This test has been authorized by the FDA under an EUA for use by authorized laboratories.
- This test has not been FDA cleared or approved.
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This product is intended for professional use and not for home use.
- Not for the screening of donated blood.
Documentation from Healgen:
Healgen COVID 19 Antibody Test Fact Sheet for Recipients
Healgen COVID 19 Antibody Test Fact Sheet for Healthcare Providers
Other Tests Available at Oswald’s
Drive Up Rapid COVID-19 Antigen Test. Click here for more information and scheduling options.
48-Hour Drive Up PCR/Molecular COVID-19 Test. Click here for more information and scheduling options.
Further Reading from the FDA
