ZNG Medical
INTENDED USE: A rapid chromatographic immunoassay for the qualitative detection of antibodies (IgM) to Mycoplasma pneumoniae in Whole Blood, Serum, or Plasma. It serves as a critical aid in the diagnosis of Mycoplasma pneumoniae viral infections.
PRINCIPLE: Mycoplasma pneumoniae (MP) is a common pathogen causing atypical pneumonia and respiratory diseases. MP-IgM is the specific antibody that appears first after infection (detectable within 7 days). This visual test utilizes immunochromatography technology and provides results within 15 minutes.


✅ Positive: Two lines appear. One colored line in the control region (C) and another adjacent colored line in the test region (T).
❌ Negative: Only one colored line appears in the control region (C). No line in the test region (T).
⚠️ Invalid: Control line (C) fails to appear due to insufficient specimen volume or incorrect procedure. Repeat with a new cassette.
| Feature | Details |
|---|---|
| Item Name | Mycoplasma Pneumoniae IgM Rapid Test |
| Methodology | Sandwich Colloidal Gold |
| Specimen | Whole Blood / Serum / Plasma (S/P/WB) |
| Format | Cassette (2.5mm / 3.0mm / 4.0mm) |
| Shelf Life | 3 Years |
| Accuracy | > 99.99% |
| Reaction Time | 3 - 5 Minutes |
| Certificates | CE, ISO, FSC |



