The assaya ABC Flu & COVID-19 Antigen Rapid Test is a rapid in vitro immunochromatographic assay intended for the qualitative detection of antigens from influenza type A, type B and SARS-CoV-2 viruses in nasal secretion from individuals within the first five days of the onset of symptoms. Antigens from influenza type A, type B and SARS-CoV-2 viruses is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results are presumptive, and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out influenza type A, type B and SARS-CoV-2 virus infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms. The assaya ABC Flu & COVID-19 Antigen Rapid Test is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel.
Each box contains 50 test kits. Each test kit contains:
Storage And Disposal
The product should be stored at 15-30 °C. Do not refrigerate or freeze. Keep away from direct sunlight. Do not freeze or overheat the test kit or kit reagents. Kit contents are stable until the expiration date printed on the outer box. The indicators must be kept in the foil pouch until use.
Before use, check the expiration date of the packaging. If the kit is past its expiration date, do not use. Confirm that all components needed are in the kit.
Stand up the Spacket, and tear it open. Be careful not to spill the liquid reagent inside.
Obtain the sterile SWAC. Make sure the SWAC head does not touch anything until sample collection.
Insert the SWAC into the nostril that presents the most secretions under visual inspection. Keep the SWAC near the septum floor of the nose in the nasal anterior. Rotate the SWAC 5 times in each nostril.
Put the SWAC into the Spacket. Roll the SWAC 5 times. Leave the SWAC in the Spacket for 1 minute before inserting the test indicator.
While the SWAC remains in the Spacket, place the test indicator into the Spacket with the droplets going down. Leave the test indicator in the Spacket for 10 minutes. Use the assaya timerDx to keep track of the test time.
Take out the test indicator and read the result at 10 minutes. Do not read the result after 20 minutes. To confirm the result, the test indicator may also be read by the intelligent analyzer eXpress (iaX-2101) after 10 minutes.
Positive Indicator Line Legend
At 10 minutes, the appearance of the Control Line and ANY shade of Test Line (Flu A, Flu B, COVID-19) on the Test Indicator, indicates a positive result for the presence of Influenza type A, B, and/or SARS-CoV-2 viral antigen.
Please refer to the Indicator Line Legend to interpret the test lines.
After 10 minutes, if only Control Line area shows a line, it means a negative result. A negative result indicates that the presence of influenza type A, influenza type B, and/or SARS-CoV-2 viral antigen is negative in the specimen, or the antigen level is below the detection limit.
If after 10 minutes, the Control Line does not appear, even if any Test Line appears, the result is considered invalid. When invalid, a new test must be performed with a freshly collected specimen sample.
Two internal procedural controls are needed to confirm correct assay procedure and active kit components. One of two is a line appearing in the “Control Line” area in every run of the test to assess validity of the test. Another one is a clear background serving as an internal negative control. The background color should be white and not interfere with the reading of the test.
Result Interpretation with the iaX-2101
Please refer to the full iaX-2101 Instructions for Use for complete instructions on how to operate the IaX.
Place the test indicator into the iaX-2101, with the barcode pointing in.
GREEN – (NEGATIVE)
YELLOW ! (INVALID)
RED + (POSITIVE)
Warnings & Precautions
Limit of Detection (LoD)
The limit of detection (LoD) for the assaya ABC Flu & COVID-19 Antigen Rapid Test was established in an analytical sensitivity study performed in clinical nasal matrix. The LoD concentrations identified for each strain tested are listed in the table below.
Nasal spray products and common chemicals were evaluated and did not interfere with the assaya ABC Flu & COVID-19 Antigen Rapid Test in clinical nasal matrix at the levels tested below.
The cross-reactivity of assaya ABC Flu & COVID-19 Antigen Rapid Test was performed on the positive and negative clinical matrix containing high levels of non-target microorganisms. Bacteria was tested at a target concentration between 106 and 1010 cfu/mL and viruses were tested at concentrations between 105 and 108 TCID50/mL (or pfu/mL). Each was tested in triplicate in the absence or presence of 2xLoD of gamma inactivated SARS-CoV-2. No cross-reactivity or interference was seen when tested at the potentially interfering concentrations. The bacteria and viruses tested were listed in the below Table.
Adverse Events Reporting
Use this link to report any adverse events: assaya.com/ae
Catalog Number (REF): AKIT-ABC-01
50 pcs per box (Carton of 50 test kits)
In Vitro Diagnostic Medical Device
Consult Package Insert
Do not reuse
Contains sufficient for <n> tests
Do not use if package is damaged and consult Package Insert
Nasal SWAC and Spacket