DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1.Remove the test from the foil pouch and use it within one hour.
Best results will be obtained if the test is performed immediately after opening
the foil pouch.
2.Place the test on a clean and level surface.
For Serum or Plasma specimen:
Transfer 10μL of serum or plasma to each of the specimen well (S)
with a dropper or pipette, then add 2 drops of buffer (approximately 80
uL), and start the timer.
For Whole Blood specimen:
Transfer 20μL of whole blood to each of the sample well(S) with a
dropper or pipette, then add 2 drops of buffer (approximately 80 uL), and
start the timer.
3.Wait for the colored line(s) to appear. Read results at 10
minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after
opening the vial.
INTERPRETATION OF RESULTS
IgG POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line should be in
the IgG line region.
IgM POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line should be in
the IgM line region.
IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test
lines should be in the IgG line region and IgM line region.
*NOTE: The intensity of the color in the test line regions may vary
depending on the concentration of SARS-COV-2 or Mycoplasma pneumoniae
antibodies present in the specimen. Therefore, any shade of color in the test
line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C).
No line appears in the IgG region and IgM region.
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with a new test.
If the problem persists, discontinue using the test kit immediately and
contact your local distributor.
SPECIMEN COLLECTION AND PREPARATION
The COVID-19 and Mycoplasma pneumoniae IgG/IgM Combo Rapid Test
(Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
To collect Fingerstick Whole Blood Specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol pad. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign
of blood.
Gently rub the hand from wrist to palm to finger to form a rounded
drop of blood over the puncture site.
Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:
Touch the end of the capillary tube to the blood until filled to approximately 20L. Avoid air bubbles.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
Testing should be performed immediately after the specimens have
been collected. Do not leave the specimens at room temperature for
prolonged periods.
Serum and plasma specimens may be stored at 2-8°C for up to 7 days, for long term storage, serum/plasma specimens should be kept
below -20°C. Whole blood collected by venipuncture should be stored at
2-8°C if the test is to be run within 2 days of collection. Do not freeze
whole blood specimens.
Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to testing.
Specimens should not be frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance
with local regulations covering the transportation of etiological
agents. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can
be used as the anticoagulant for collecting the specimen.
Order information
Cat. No. | Product | Specimen | Pack |
INMC-425 | COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test | WB/S/P | 25 T |
INMCG-425 | COVID-19 and M.pneumoniae IgG Combo Rapid Test | WB/S/P | 25 T |