Performing Test & Interpretation
The Rapcov™ COVID-19 Rapid test is a lateral flow immunochromatographic assay. The 2019-nCoV recombinant nucleocapsid protein is used to detect antibodies to 2019-nCoV in fingerstick whole blood from patients who are suspected of COVID-19 virus infection.
To use the Rapcov™ COVID-19 Rapid test, the device cassette, specimen, and buffer solution are allowed to equilibrate to room temperature.
Step 1: Fingerstick whole blood collection: Blood sample is obtained by fingerstick using TRUEplus Safety Lancet and collected using MicroSafe® pipette Specimen (10 μL). The health care provider washes hands thoroughly and put on gloves. Select the site: The patient should be sitting or lying down. The health care provider holds patient’s hand in a downward position, allowing gravity to help increase blood supply to the hand and selects middle or ring finger for fingerstick. The health care provider twists off the tab of to break the seal and discard the cap and performs the puncture by positioning the safety lancet firmly against the puncture site. The lancet is activated by pressing firmly against the puncture site. A blood drop forms at the puncture site. The used safety lancet is discarded into a sharps container or according to the health facility’s established procedures.
The whole blood specimen is collected using MicroSafe® pipette. The pipette is held horizontally to touch the tip to the blood sample. Capillary action automatically draws the sample blood to the air vent and it will stop.
Step 2: Transfer Blood specimen to Test Cassette well: Place the test cassette on a horizontal hard surface. To expel blood, align the tip of the pipette with the test cassette well and squeeze the bulb.
Step 3: Apply Buffer to Test Cassette well: After the sample well is free of blood, two drops of Buffer are then added to the sample well.
Step 4: Test Readout: Wait for fifteen minutes and read the test results. Results are not to be read after twenty minutes.
Interpretation of Results
The internal test control line should be examined prior to interpretation of patient results. If the control line is not visible, the test is not valid and the patient results cannot be interpreted.
Internal Control: The expected result is that a pink color line will appear in the Control line area in the viewing window of the test cassette. Appearance of a pink control line ensures correct operation of the device and that the test results are valid. If the pink color line does not appear in the Control line area, then the test is invalid and should be repeated.
Assessment of clinical specimen test results should be performed after the internal control has been examined and determined to be valid and acceptable. If the internal control is not valid, the patient results cannot be interpreted.
To use the Rapcov™ COVID-19 Rapid Test, the device cassette, specimen, and buffer solution are allowed to equilibrate to room temperature. Fingerstick whole blood specimen (10 μL) is transferred to the center of the sample well. After the sample well is free of liquid, two drops of Buffer are then added to the sample well. Wait for fifteen minutes and read the test results. Results are not to be read after twenty minutes. An IgM Positive Result occurs when a pink colored band appears at both the M Test Line (M) and Control Line (C) and indicates that IgM against SARS-CoV-2 is present. An IgG Positive Result occurs when a colored band appears at both the G Test Line (G) and Control Line (C) and indicates that IgG against SARS-CoV-2 is present. A positive result for IgM and IgG occurs when colored bands occur at both M and G as well as at C. A Negative Result occurs when a colored band appears at C only and indicates that IgM and IgG antibodies against SARS-CoV-2 were not detected. An Invalid Result occurs when no colored band occurs at C and the test should be repeated.