C.Pneumonia Immunoassay System IVD Rapid Test Kit IFA and Colloidal Gold Diagnostic WWHS Reagent Cassette

Intended Use

Diagnostic Kit(Colloidal Gold)for IgM Antibodv to Chlamydia Pneumoniae is a colloidal gold immunochromatographic assay for the qualitative determination of IgM Antibody to Chlamydia Pneumoniae (Cpn-IgM) in human whole blood,serum or plasma, it acts as chlamydia pneumonia infection auxiliary diagnosis reagent in clinical diagnosis. Meanwhile it is a screening reagent. All positive sample must be confirmed by other methodologies.This test is intended for healthcare professional use only.

About NIR-1000 Dry Fluoroimmunoassay Analyser

It is a fluorescence immunochromatographic analysing system with internal temperature control, which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.

* Immunofluorescence technology

* Testing time less than 15 minutes

* Easy-to-use touch-screen platform,multi-language system

* Reagents stored at room temperature for 12 months

* Dry immune technology, maintenance free

Smarter Operation

1. High Quality: Imported Major Components with Importing Advanced Technology

2. User-Friendly Design: 7 Inch touch screen, great touch feeling, simple graphic

interface

3. Built-In Lithium Battery: High Mobility for first aid&amulance

4. Two Test Mode: Internal&External mode for different clinical needs

5. Smart Report: Auto Printing

6. Visual Results: Able to connect with LIH/HIS

Note:

1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay

WWHS Inflammation Assay List

Quality Control

A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural
control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that a positive control and a negative control control be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

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