TITLE: Boston Biopharma CareStart™ Rapid Diagnostic Antigen Test
AUTHORS: tclark , Ahmad Hashem, Jun Yong Ha, Charlie Mize

[STEPS]
?. [Temperature Equilibrium]
Allow test devices, reagents, specimens, and/or controls to equilibrate to room temperature (15~30°C) prior to testing
0 Room temperature
?. [Nasopharyngeal Swab Specimen Collection]
Remove a nasopharyngeal swab from the pouch.
Use only provided or recommended nasopharyngeal swab for specimen collection.Do not touch the tip (specimen collection area) of the swab.Acceptable specimen type for testing with the CareStart™ COVID-19 Antigen is a direct nasopharyngeal swab specimen. It is essential that correct specimen collection and preparation methods be followed. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, specimen collection requires specific training and guidance due to the importance of specimen quality to obtain accurate test results.
?. [Nasopharyngeal Swab Specimen Collection]
Place the swab into one of the patient’s nostrils until it reaches the posterior nasopharynx.
?. [Nasopharyngeal Swab Specimen Collection]
Slowly rotate 3-5 times the swab over the surface of the posterior nasopharynx.
?. [Nasopharyngeal Swab Specimen Collection]
Remove the swab from the nostril.
?. [Test Procedure]
Remove the CareStart™ COVID-19 Antigen test device and extraction vial from its foil pouch immediately before testing.
?. [Test Procedure]
Peel off aluminum foil seal.
?. [Test Procedure]
Place the swab into the extraction vial. Rotate the swab vigorously at least 5 times.
?. [Test Procedure]
Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab.
Properly discard the swab.
?. [Test Procedure]
Close the vial with the provided cap and push firmly onto the vial.
?. [Test Procedure]
Mix thoroughly by flicking the bottom of the tube.
?. [Test Procedure]
Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
?. [Test Procedure]
Read and interpret the test result at 10 minutes. The test result should not be read and interpreted after 15 minutes.
[Read after 10 minutes but before 15 minutes]
?. [Interpretation of Results]
The test results should be read and interpreted at 10 minutes after the sample application and the reading and interpretation of the results should not exceed 15 minutes. The test results should not be interpreted using any instruments.
?. [Interpretation of Results]
Positive Result: One red-colored line next to “C” and one blue-colored line next to “T” indicates COVID-19 positive result.
NOTE: The color intensity in the test region will vary depending on the amount of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
?. [Interpretation of Results]
Negative Result: One red-colored line only next to “C” indicates a negative result.
?. [Interpretation of Results]
Invalid Result: If the red-colored line in the control region “C” is not visible, the result is invalid. Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
?. [Limitations]
The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen collection, handling, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
?. [Limitations]
This test will only indicate the presence of SARS-CoV-2 nucleocapsid protein antigen in the specimen from both viable and non-viable SARS-CoV-2 virus.
?. [Limitations]
This device is a qualitative test and does not provide information on the viral concentration present in the specimen.
?. [Limitations]
This test cannot rule out diseases caused by other bacterial or viral pathogens.
?. [Internal Quality Control]
The CareStart™ COVID-19 Antigen contains a built-in internal procedural control that is included in the test device. A red-colored line appearing in the control region “C” is designed as an internal procedural control. The appearance of the procedural control line indicates that sufficient flow has occurred, and the functional integrity of the test device has been maintained. If the procedural control line does not develop in 10 minutes, the test result is considered invalid and retesting with a new device is recommended. If the internal procedural control line is still absent in the retest, please contact the manufacturer or distributor.
?. [External Quality Control]
External control is used to demonstrate that the test device and test procedure perform properly. It is recommended that positive and negative external control swabs are run once with every new lot, shipment, and each new user. External positive and negative control swabs are provided in the kit. The external control should be tested using the nasopharyngeal swab test procedure provided in this package insert or the quick reference instruction card. If the external control results are invalid, please contact the manufacturer or distributor before testing patient specimens.