ACCESSBIO

CARESTART™
COVID-19
ANTIGEN TEST

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 This test is approved is intended for use by trained
operators and is for use under the Food and Drug
Administration (FDA) Emergency Use Authorization
(EUA) in settings which meet the CLIA requirements to
perform moderate, high, or waived complexity tests.

CARESTART™ COVID-19 ANTIGEN TEST

OBJECTIVES
 Review how the test works
 Safety and PPE
 Performing the test
 Result interpretation
 Disposal / Clean Up

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SAFETY
 Treat everything like it’s positive for COVID-19
 Wear PPE
 Don’t use cell phones or touch personal items while testing
 Clean hands after removing gloves
 Do not eat or drink while doing testing
 Use appropriate disinfectant for clean-up (effective against
COVID-19)
 Avoid touching hands and face while testing

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CC BY-SA
 HOW CARESTART™
WORKS
CareStart is a lateral test device in which the
swab sample is eluted into extraction buffer
solution and added to the test device
The sample migrates through the test strip
and the SARS-CoV-2 antigens in the sample
combine with antibodies specific for SARS-
CoV-2
The antigen/antibody complex binds to an
indicator and is captured on the test strip then
visualized as a line on the “T” Test line
how do lateral flow assays work - Bing images
This test contains an internal control
indicated on the “C” Control line which must
appear for a valid test result
PERSONAL PROTECTIVE
EQUIPMENT (PPE)
 Respiratory Protection: Fitted N-95 is preferred. If N-95 is
not available, use a surgical mask and face shield. Consult CDC
resources for alternatives when N-95’s are not available.

 Eye/Face Protection: Safety glasses with N-95 or face

shield with any respiratory protection

 Clothing Protection: If disposable lab coats are not

available, consider bringing a change of clothes in case of
contamination

 Gloves: mandatory for all steps of collection and testing

TEST KIT COMPONENTS
 Nasopharyngeal (NP) Swab: Sample must be collected by
trained provider
 COVID-19 Antigen Extraction Vial
 Extraction Vial Caps
 COVID-19 Antigen Test Device
 Disposable vial holders/racks for holding the vials during the
test set-up
 All waste is disposed as biohazardous waste
 NEEDED BUT NOT PROVIDED

 All waste is disposed as biohazardous waste: Do not put test materials or PPE in
regular garbage

 Disinfectant effective against COVID-19

 60-80% ethanol/isopropanol
 10% bleach solution
 Other effective EPA registered disinfectant
 Paper towels or absorbent material
 Hand sanitizer to use between patients after removing gloves
 SET UP THE TEST AREA- 1

 Allow all materials to equilibrate to room temperature before testing.

 Spread a paper towel out to use as a work surface- keep the table cleaner
 Find a timing device: a wall clock or kitchen timer works. Do not use your cell
phone (contamination risk)
 You will need a biohazard waste container near your test space
 Have disinfectant handy and clean often, especially items that you touch with
your gloves: pens, timers, etc.
SET UP THE TEST AREA- 2

 Assemble a disposable elution tube rack found in the test box to hold the
tube upright. To prevent contamination between tubes, use a Sharpie to
mark it with an X when you’ve put a tube in that position.
 Remove test device immediately before testing (do not open multiple at
once)
 Use a sharpie to write a patient identifier on the elution tube and test device.
To protect patient privacy, use an identifier other than patient name.
 Remove the aluminum foil seal from the elution tube
 Begin sample collection (NP swab)
TEST SET UP
 SAMPLE COLLECTION
 Trained personnel will collect a nasopharyngeal (NP)sample using
the swabs provided in the kit.
 Nasal washes and aspirate samples are not acceptable for testing
 Wear appropriate PPE during collection (gloves, respiratory
protection and mucous membrane protection at minimum).
 The swab should be tested immediately after sample collection.
 Specimens are stable for 4 hours in the extraction buffer

 Swab specimens can be placed in BD universal transport media (this requires a small change in
the testing procedure and a 400µl pipette) See the pkg insert for procedure.
Test Procedure
1. 2. 3. 4.
Remove the swab by Invert the extraction
rotating against the vial and hold the
Peel off aluminum foil Close the vial by
extraction vial while sample vertically
seal and rotate the pushing the cap firmly
squeezing the sides of above the sample well.
swab inside the onto the vial and mix
the vial to release the Squeeze the vial
extraction vial thoroughly by flicking
liquid from the swab. gently.
vigorously at least 5 the bottom of the tube.
Discard the swab in Allow three (3) drops
times
biohazard waste. of sample to fall into
the sample well.
Read and Interpret Results After 10 Minutes

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The test result should not be read or interpreted after 15 minutes.

***For safety reasons, do not use personal cell phone as a timer***
 Result Interpretation
COVID-19
POSITIVE
 Red Control Line “C” visible
 Blue Test Line “T” visible
 Any faint colored line in the
test region is considered
positive
COVID-19 INVALID
 If the red-colored line in the
NEGATIVE
Control region “C” is not
visible, the result is invalid
 Red Control Line “C” must be
(even if Test “T” line is visible)
visible  Repeat test using remaining
 No Test Line “T” (blue) visible sample in the extraction vial
with a new test device (within
4 hours of addition to
extraction buffer)
TEST LIMITATIONS

 Excess blood or mucous in the specimen may yield false-

positive results
 Avoid touching any bleeding areas of the nasopharynx
when collecting specimens
 False negative results may occur in patients taking >10mg
of biotin per day
 Biotin levels of 2.5 mg/mL may result in false negative
test results.

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 DISPOSAL

 After the test is reported, dispose of all materials

in the biohazard container
 Remove your gloves, use hand sanitizer and put-
on clean gloves before collecting and testing the
next sample.
 Disposable PPE should also be discarded as
biohazard waste.

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FINALLY
 Read the package insert found in the test kit before
performing this test.
 For questions or to report a problem, contact the
manufacturer’s technical support line, found in the package
insert.
 Some assistance can be given at
checcdeptcoor@michigan.gov
 Return the training quiz to Bureau of Laboratories

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