Anti-Pseudomonas aeruginosa IgG ELISA Kit

Name: Anti-Pseudomonas aeruginosa IgG ELISA Kit
SKU: DEIA-NS2668
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Serum and plasma

Species Reactivity

Human

Detection Method

Indirect-ELISA

Intended Use

The kit is intended for professional use for the quantitative detection of IgG antibodies against Pseudomonas aeruginosa antigens in human serum and plasma.

Contents of Kit

No.	Components	Size	Storage Conditions
1	ELISA Microplate(Dismountable)	96T (8×12)	2-10°C
2	Standard A	1.3 mL × 1	2-10°C
3	Standard D	2.0 mL × 1	2-10°C
4	Standard E	1.3 mL × 1	2-10°C
5	Anti-IgG Px conjugate	13 mL × 1	2-10°C
6	Wash buffer (10× concentrated)	55 mL × 1	2-10°C
7	Dilution buffer	60 mL × 1	2-10°C
8	Chromogenic substrate TMB	13 mL × 1	2-10°C
9	Stop solution	13 mL × 1	2-10°C

Storage

It is recommended to use the kit within three months after opening.
1. Store the kit and the kit reagents at +2 °C to +10 °C, in a dry place and protected from the light. Under these conditions, the expiration period of the entire kit is indicated on the central label on the kit package, the expiration date of the individual components is indicated on their package.
2. Put unused strips back in the package and seal or close tightly in a zippered bag with desiccant.
3. The kits are transported refrigerated in thermal bags, transport time up to 72 hours has no influence on expiration. If, upon receipt of the kit, you notice serious damage to the packaging of any component of the kit, inform the manufacturer immediately.
4. Store unused test samples undiluted, aliquoted and frozen at -18 °C to -28 °C. Frequent freezing and thawing is not recommended. If you store samples at + 2 °C to + 10 °C, then test them within one week.
5. Test sample solutions at the working concentration cannot be stored. Always prepare them fresh.

Performance Characteristics

Diagnostic sensitivity and specificity of the test: Diagnostic sensitivity and specificity were determined by testing the characterized samples on the anti-Pseudomonas aeruginosa IgG ELISA kit. The result was confirmed by an independent commercial test and/or characterization of samples as part of an internal performance evaluation study. Sensitivity determined from the given samples was 94.53 %, specificity 96.64 %.
Analytical sensitivity of the test: The analytical sensitivity of the test is defined as the mean value of the analyte-free sample plus three times the standard deviation and represents the smallest detectable antibody titer. The analytical sensitivity value is determined for each kit lot and is listed in the Quality Control Certificate for that kit lot.
Analytical specificity of the test: The quality of the specific antigens used, which recognize specific antibodies in patient samples, ensures high specificity.
Measurement range: The measurement range is determined by the measuring capability of the used spectrophotometer/colorimeter.
Limit of determination: The limit of quantification is defined as the lowest measurable concentration that can be distinguished from zero with 95% confidence. This value is determined for each kit lot and is listed in the Quality Control Certificate of that kit lot.

Precision

The interassay variability (between tests) and the intraassay variability (within the test) were determined by testing samples with different OD values.
Repeatability (intraassay)
The variation coefficient of intraassay is max. 8%. It is measured for each particular lot at least on 12 parallels of the same microtiter plate.

Reproducibility (interassay)
The variation coefficient of reproducibility is a maximum of 15%. It is measured for each lot by comparing the wells of the same sample in several consecutive tests.

General Description

Pseudomonas aeruginosa is a gram-negative bacterium that causes about 10% of all nosocomial infections. This opportunistic pathogen leads to acute and chronic types of infection in various organs. It is the most important bacterial pathogen in patients with cystic fibrosis, in whom chronic lung infection is responsible for most of the morbidity and mortality. Chronic Pseudomonas aeruginosa infection can be reliably distinguished from intermittent colonization by measuring serum IgG antibodies to Pseudomonas aeruginosa. Significant and increasing antibody response develops during chronic infection, whereas it is not observed in intermittently colonized patients. The level of antibody response in chronically infected patients correlates with the severity of the infection. Because the patients with cystic fibrosis may experience repeated colonization with Pseudomonas aeruginosa, they will be exposed to repeated courses of antibiotic therapy. Measurement of the antibody response in such cases may be useful in monitoring the patient's response to infection management and therapy.

Citations