This ELISA is intended for the quantitative and qualitative analysis of kanamycin residue in biological samples. For research use only.
Contents of Kit
No.
Components
Size
Storage Conditions
1
Microtiter plate, pre-coated
12×8 wells
2-8°C
2
Wash buffer concentrate 20×
1 × 40 mL
2-8°C
3
Sample diluent concentrate 2×
1 × 50 mL
2-8°C
4
Antibody solution
1 × 10 mL
2-8°C
5
Standards
6 × 1 mL
2-8°C
6
Spiking standard solution 1 μg/mL
1 × 1 mL
2-8°C
7
Enzyme conjugate
1 × 7 mL
2-8°C
8
Substrate Solution
2 × 6 mL
2-8°C
9
Stop solution
1 × 7 mL
2-8°C
Storage
When stored unopened at 2-8°C, the kit remains stable until the expiration date printed on the package. The total shelf life from manufacturing is 12 months. Do not use beyond the expiration date.
Precision
Assay precision was determined by both intra (n=5 assays) and inter assay (n=5 assays), CV of the ELISA kit all less than 10%. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.
Intra Assay %CV
Inter Assay %CV
<10%
<10%
Detection Range
0.5-40.5 ng/mL
Sensitivity
0.5 ng/mL
General Description
Kanamycin or kanamycin A is an aminoglycoside bactericidal antibiotic, used to treat a wide variety of infections and tuberculosis. Kanamycin is isolated from the bacterium Streptomyces kanamyceticus and its most commonly used form is kanamycin sulfate. Kanamycin is commonly used as an antibiotic during the cell culture process. Regulatory authorities across the world have restricted and sought to quantify the Kanamycin residue in view of its potent action on human beings in the in-process and finished pharmaceutical products. Kanamycin residue in the production of biological products may lead to abnormal reactions of human beings, thus strict MRLs have been established. This kit is a rapid test product for the determination of kanamycin residues which is sensitive, accurate and time-saving. It can considerably reduce the operation errors in the assay.
Standard Curve
This curve cannot be used for the assay calculations and is listed for quality control purpose only. New standard curve must be generated each time the assay is run.
Citations
Publication ()
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Background
Kanamycin was first isolated in Japan in 1957, as a member of the sugar-containing antibiotics, the aminoglycosides, it is a tri-saccharide composed of a deoxystreptamine and two glucosamine units, chemically designated 3-D-glucosamine- 2-deoxystreptamine-6-o-glucosamine. It has broad-spectrum activity and can inhibit bacterial protein synthesis. Kanamycin can treat severe bacterial infections and tuberculosis by oral, intravenous or intramuscular injection, but it is not first-line treatment and is only recommended for short-term use (7-10 days). High water-solubility and absence of delayed toxicity are some of the additional advantages of kanamycin over other actinomycete-derived antibiotics.
Figure 1. Structure of kanamycin (Source: Drugbank online)
Kanamycin was first isolated in 1957 by Hamao Umezawa from the bacterium Streptomyces kanamyceticus. It was removed from the WHO's list of essential medicines in 2019. Although kanamycin has been successfully used in the treatment of M. tuberculosis, it has been largely replaced by the third generation antibiotics, such as cephalosporins, carbapenems and fluoroquinolones. This is partly due to the widespread drug resistance of bacteria that limits the clinical application of kanamycin, and partly because of the serious side effects of aminoglycosides, such as ototoxicity, nephrotoxicity, and drug allergy. However kanamycin is widely used in veterinary medicine. It can be used to prevent and treat gastrointestinal infections in animals and, for cattle, to prevent and treat mastitis.
In view of the serious side effects of kanamycin, the detection of kanamycin residues in biological products can help us to understand the residues in time and evaluate the biosafety. Creative Diagnostics can provide you with qualitative and quantitative kanamycin ELISA kit, which is sensitive, accurate and time-saving.
Alternative Names
KAM ELISA Kit KAN ELISA Kit
References
1. Xie J, et al. New developments in aminoglycoside therapy and ototoxicity. Hear Res. 2011 Nov;281(1-2):28-37.
2. Hotta K, et al. Kanamycin and its derivative, arbekacin: significance and impact. J Antibiot (Tokyo). 2018 Mar;71(4):417-424.
Q: The customer received the CoA showing that the product was tested by QC department and released according with specifications.
Now she is asking: Could I get information on what tests were performed? Was a purity test performed? Or what other tests were performed? Thank you in advance and I look forward to hearing from you.
A: 1. Standard Curve Validation Acceptance Criteria: R² ≥ 0.990; IC50 range: 0.8 ng/ml ～ 2.0 ng/ml 2. Sample Recovery Test Acceptance Criteria: 80% - 120% 3. Precision Testing Coefficient of variation (CV) for 0 ng/ml (Standard 1), 0.5 ng/ml (Standard 2), and 1.5 ng/ml (Standard 3) is < 8% CV for spiked samples at 0 and 3 ng/ml concentrations should be < 15% 4. Accelerated Stability/Aging Test All kit components monitored under 37 °C accelerated aging for 16 days; kit parameters remained stable 5. Additional Performance Verification: Functional validation of all kit components (coated plates, standards, conjugates) Specificity screening against potential cross-reacting compounds: 100% cross-reactivity with kanamycin; cross-reactivity with streptomycin, dihydrostreptomycin, and neomycin all < 1%
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References
New developments in aminoglycoside therapy and ototoxicity
After almost seven decades in clinical use, aminoglycoside antibiotics still remain indispensible drugs for acute infections and specific indications such as tuberculosis or the containment of pseudomonas bacteria in patients with cystic fibrosis. The review will describe the pathology and pathophysiology of aminoglycoside-induced auditory and vestibular toxicity in humans and experimental animals and explore contemporary views of the mechanisms of cell death. It will also outline the current state of protective therapy and recent advances in the development of aminoglycoside derivatives with low toxicity profiles for antimicrobial treatment and for stop-codon suppression in the attenuation of genetic disorders
Kanamycin and its derivative, arbekacin: significance and impact
On the occasion of the 60th anniversary of the discovery (1957) of kanamycin (KM), a series of research achievements on KM and its semisynthetic derivative Arbekacin (ABK) are outlined. KM was first used clinically in 1958 and was appreciated for its remarkable curing effect on various bacterial infections, especially tuberculosis. ABK is a KM derivative rationally semisynthesized to overcome KM resistance due to enzymatic phosphorylation and acetylation. Since its approval in 1990 as an anti-MRSA drug, ABK has been and still is effectively used in chemotherapy because MRSA rarely develops high ABK-resistance. Research that illuminated the unique features of ABK enabling it to resist the development of resistance by MRSA are also described.
COA
Publication 
Figure 1. Structure of kanamycin
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