Coronavirus Tests

Covid-19 is known for being a highly-infectious disease that is spreading rampantly throughout the world. It is caused by the Sars-CoV-2 virus and is capable of producing mild to severe respiratory illness, affecting any individual, especially those who are medically-compromised and elderly. Reliable brands such as Celltrion Diatrust, BD Veritor & Quidel, have produced Rapid Tests, which are immunoassay tests that are used for the direct and qualitative detection of Coronavirus (Sars-CoV-2) antigens and antibodies collected through serum, saliva, plasma, and even whole blood of patients.

Types of Covid-19 Rapid Tests

There are two types of Rapid Tests that are helpful in the systematic screening and detection of both clinical and asymptomatic COVID-19 cases: Antigen or Ag Rapid Test, and Antibody Rapid Test.

Antigen Rapid Tests: Ag or Antigen Rapid Test is the type of Covid-19 Rapid Test which detects extracted nucleocapsid protein antigens, specific to SARS-CoV-2, in specimens directly collected through nasopharyngeal swabbing. This effectively works in detecting active infection for asymptomatic patients, with a certain time interval in test swabbing, or symptomatic patients, depending on the days of symptom onset. Results will instantly appear on the test device in as fast as 10-30 minutes, and a follow-up test may be needed to confirm a positive result.

Antibody Rapid Tests: This type of Covid-19 Rapid Test is mainly used in detecting and differentiating Covid-19 IgG, IgA and/or IgM antibodies collected from patients. Specimens for testing can be obtained in human serum, plasma, venous or fingerstick whole blood, which helps in identifying individuals who have active immune responses to Sars-CoV-2, indicating recent or a history of having the Covid-19 infection. This antibody test can be used for individuals that are 15 days or more post symptom onset, and results will instantly appear on the test device in as fast as 10-30 minutes.

Available Rapid Test Kits

Tiger Medical has a variety of Covid-19 Rapid Test products from different brands, which are authorized by the FDA under the Emergency Use Authorization (EUA), for the rapid detection of proteins and antibodies from SARS-CoV-2 and not for any other viruses or pathogens.

Covid-19 Antigen Rapid Tests from Access Bio - CareStart, Celltrion DiaTrust, Clarity Diagnostics & Quidel Sofia 1 and Sofia 2, are exclusively intended for Point-of-Care testing held by healthcare professionals, and the specimen used is human serum acquired from nasopharyngeal swabbing. BD Veritor has the same features, but the only difference is the need of the Veritor Plus Analyzer for testing. Antigen Rapid Tests that can be used either for Point-of-Care or home use are offered by Orasure - InteliSwab and Quidel - QuickVue.

Covid-19 Antibody Rapid Tests use serum, saliva, plasma, venous or fingerstick whole blood for testing and differentiating IgG, IgM, and/or IgA antibodies. Premier BioTech offers 2 kits, the Premier Covid-19 Rapid Test & the Premier - FaStep, both used for effective antibodies (IgG & IgM) detection from serum, plasma, venous and fingerstick whole blood. Clarity Diagnostics - COVIBLOCK is also available in detecting IgG and IgM antibodies. The Covab Covid-19 Antibody Rapid Test from Diabetomics offers a non-invasive antibody test, detecting all the antibodies (IgG, IgA & IgG) through oral swabbing and acquiring saliva from the patient.

Covid-19 Rapid Test General Instructions of Use

There are two ways of administering the available Covid-19 Rapid Tests: Point-of-Care Testing, which is done on-site, may it be in a CLIA-approved medical facility or laboratory, and is administered by a certified healthcare professional. Home Use or Take-Home Rapid Test Kits are also available, wherein an individual can take the swab test in the safety of his home.

For point-of-care testing, a strict infection control must be implemented, and a proper use of the recommended personal protective equipment (PPE), such as N95 or higher level respirator (medical facemask can be considered), eye protection, disposable medical gloves, and a gown, is needed to effectively avoid cross-contamination between patients.

For Covid-19 Antigen Rapid Tests

The following steps are the general ways of administering the available Rapid Test Kits (an in-depth guide of proper testing is included as an insert in all the Rapid Test Kits) :

1. Sample Collection: Each test kit comes with a sterile, disposable specimen collection swab, which is then inserted into a patient’s nostrils until it reaches the posterior nasopharynx. Once a resistance is reached, the healthcare professional will swirl the swab 3-5 times to get the accurate amount of specimen needed for testing. The swab is then removed slowly while still twisting.

2. Sample Preparation: Immediately prepare the extraction reagent tube included in the test kit, and insert the swab with the specimen, making sure that enough sample is incorporated within the solution. Properly discard the swab right after.

3. Detection: The solution from the extraction tube is dispensed (3 drops) into the sample well of the test device. The test result may show up in about 10-15 minutes, depending on the proper time indicated in the guidelines of the Rapid Test Kit. It is also noted that false positive or negative results can occur if the test device is read before the specified time and 10 minutes after.

4. Interpretation of Results: A solo colored horizontal mark on the "C" (control) area depicts a negative result while a positive result shows two colored marks for the "C" and "T" (test) zones. Invalid results show no lines on the "C" zone. These are standard result interpretations but may vary depending on the Rapid Test Kit that you will use, and a confirmatory test may be needed.

For Covid-19 Antibody Rapid Tests

The following steps are the general ways of administering the available Rapid Test Kits (an in-depth guide of proper testing is included as an insert in all the Rapid Test Kits) :

1. Sample Collection: The Covid-19 Antibody Tests use human serum, saliva, plasma, venous or fingerstick whole blood as the specimen for testing. Most of the Rapid Tests offered by Tiger Medical focus on plasma, serum or blood and are acquired through nasopharyngeal swabbing, pricking of fingers, or venous blood collection. The Diabetomics Covab Antibody Test uses saliva as the specimen for sampling, and it is acquired through oral swabbing.

2. Sample Preparation: For venous and fingerstick whole blood specimens, the blood is transferred into the specimen well, while for plasma or serum specimens, a common anticoagulant is mixed to separate the specimen from blood, and then transferred to the sample well.These types of preparation needs a buffer solution which is added to activate the testing process. If the specimen is saliva, the swab with saliva is dipped into the reagent tube and directly added to the well for testing.

3. Detection: The test result may show up in about 10-15 minutes, depending on the proper time indicated in the guidelines of the Rapid Test Kit. It is also noted that false positive or negative results can occur if the test device is read before the specified time and 15 minutes after.

4. Interpretation of Results: There are 3 zones, control "C", IgG, and IgM, and a positive result can be shown if there is a horizontal line on "C" and a solid line on either or both of the IgG and IgM zones. A solo line on "C" depicts a negative result, and invalid result is when there is no line on the control zone. This antibody test does not detect acute Covid-19 infection.

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