COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test,Whole Blood/Serum/Plasma
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
WB/S/P |
| Certificate |
CE |
| Reading Time |
10 minutes |
| Pack |
25 T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen. It is for professional use only and is intended to be used as an aid in the diagnosis of patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests.
INTENDED USE
The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-COV-2 and Mycoplasma pneumoniae in human whole blood, serum or plasma specimen.
The COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of
patients with suspected SARS-CoV-2/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests. The product is intended for use by trained laboratory personnel.
The test provides preliminary test results. Negative results will not preclude SARS-COV-2/ M.pneumoniae infection and they cannot be used as the sole basis for treatment or other management decision.
False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
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 20uL. 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.
HOW TO USE
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.
Ordering 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 |
