CareStart™

COVID-19

lgM/lgG

Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab

CareStart™ COVID-19 lgM/lgG

RAPID COVID-19 TESTING TOOL

NOW FDA EMERGENCY USE AUTHORIZED

  • For use under Emergency Use Authorization only
  • For in vitro diagnostic use only
  • For prescription use only
  • Detect and differentiate IgM/IgG antibodies specific to SARS-CoV-2
  • Requires small sample volume (10 uL of venous whole blood, serum, or plasma)
  • Results available within 10-15 minutes
  • No equipment required
  • Identify and monitor an individual’s previous infection history and immune response to COVID-19

Clinical Performance (NIH/NCI)

  • IgM Sensitivity and Specificity: 90% and 98.8%
  • IgG Sensitivity and Specificity: 100% and 98.8%

Clinical Performance against comparable method

  • IgM PPAa and NPAb: 89.06% and 99.45%
  • IgG PPAa and NPAb: 96.88% and 99.45%
  • aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement

TEST PRINCIPLES

PROCEDURE

Transfer venous whole blood, serum, or plasma sample:

  1. Using a provided blood transfer pipette: Press the top part of the provided blood transfer pipette and touch the sample by the pipette tip while pressing the pipette. Releasing the press slowly to fill the pipette with sample up to the blue marked line (approximately 10 µl). Add the blood sample to the sample well “S” of the test device by pressing the top part of the blood transfer pipette.
  2. Using a micropipette: Transfer 10 µl of the venous whole blood, serum, or plasma sample to the sample well “S” of the test device using a micropipette.
Open the cap and invert the assay buffer bottle and hold vertically above the sample well. Squeeze the bottle gently to add one (1) drop of the assay buffer solution to the sample well “S” immediately after sample loading.
Start a timer. Read the result at 10 minutes. The test results should not be read earlier than 10 minutes. Test results should not be read after 15 minutes.
RESULTS INTERPRETATION

Result with faint colored line(s): The color intensity in the test region will vary. Any faint colored line(s) in the test region(s) should be considered positive.

If the control line “C” is not visible, the result is invalid. Re-run the test using a new test device. If the same invalid result persists, contact the manufacturer or distributor before continuing to test samples.

ORDER INFORMATION
CAT.NO.
RCHM-02071
PACKAGE UNIT
20 TESTS / KIT
KIT COMPONENT
  • 20 TEST DEVICES
  • 20 ASSAY BUFFER
  • 20 EXTRACTION VIALS AND CAPS
  • 20 SPECIMEN COLLECTION SWABS
  • 1 POSITIVE AND 1 NEGATIVE CONTROL SWABS
  • 1 INSTRUCTIONS FOR USE
PRODUCT DOCUMENTATION