Uncut sheet for IgM Antibody to Mycoplasma Pneumoniae

Short Description:

IgM Antibody to Mycoplasma Pneumoniae uncut sheet

Methodology: Colloidal Gold

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

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Product Detail

Product Tags

1. INTEDED USE

The Mycoplasma pneumoniae IgM Antibody Rapid Test Device (the “uncut sheet” format for manufacturing use) is a rapid immunochromatographic assay intended for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human serum, plasma, or whole blood sample .

This test is intended for in vitro diagnostic professional use and serves as an aid in the early diagnosis of Mycoplasma pneumoniae infection, particularly in patients, including children, presenting with clinical signs and symptoms suggestive of community-acquired pneumonia, upper respiratory tract infection, bronchitis, or atypical pneumonia .

This kit only provides the test result of lgN antibody to Mycoplasma Pneumoniae, and the obtained result shall beanalyzed in combination with other clinical information.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format

2. PRODUCT SPECIFICATION

Model No.	MP-IgM Uncut sheet
Methodology	Colloidal Gold
Sample Type	whole blood/Serum/Plasma
Time to Result	15~20mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485, CE Certificate, UCKA MHRA Certificate

Feature

• High sensitive

• result reading in 15-20 minutes

• Easy operation

• High Accuracy

PACKING

* 20 bags /CTN

* Aluminum foil bag labeling

* shrink wrap

3.TEST METHOD

1	Remove detection reagent and sample to be detected from storage condition and equilibrate them to room temperature.
2	Open aluminum foil pouch of reagent, take out test device, and place it horizontally on laboratory bench;
3	Add 10uL of serum or plasma sample or 20uL of whole blood to sample hole, and then drip 100uL (about 2-3 drops) of sample diluent to sample hole and start timing.
4	Result should be read within 10-15 minutes. Test result will be invalid after 15 minutes.