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
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
| 10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
| 11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
| 12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
| 13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
| 14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
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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