ANTIBIOTIC RESISTANCE GENE TEST KIT

Test kit for detecting and differentiating antibiotic resistance genes of the Klebsiella pneumoniae Carbapenem KPC/OXA-48 and MBL (VIM, NDM, IMP) groups in bacteria of the Enterobacteriaceae family and non-fermenting bacteria (Non Fermenting Gram Negative Bacteria-NFGNB) in many types of clinical samples.

OVERVIEW OF ANTIBIOTIC RESISTANCE

The Current State of Antibiotic Resistance

   The World Health Organization (WHO) defines antibiotic resistance as the ability of microorganisms such as bacteria, viruses, fungi, or parasites to grow in the presence of a drug that would normally kill them or limit their growth. As a result, standard treatments become ineffective. Infections become more severe, leading to longer illness, higher treatment costs, and an increased risk of death. Among these, infections such as pneumonia, urinary tract infections, and tuberculosis show a high rate of antibiotic resistance

   WHO has also pointed out that antibiotic resistance is one of the top 10 global health threats. It was the direct cause of death for at least 1.27 million people worldwide and was associated with nearly 5 million deaths in 2019 (The Lancet). In the United States, there are more than 2.8 million antibiotic-resistant infections and more than 35,000 deaths each year (2019 report by the CDC). It is predicted that by 2050 the world will have 10 million cases of antibiotic resistance, equivalent to the projected number of people with cancer.

   In Vietnam, the antibiotic resistance rate is as high as 40%, making it the fourth-highest country for drug resistance in the Asia-Pacific region. Most healthcare facilities are facing the rapid spread of bacteria resistant to multiple antibiotics, especially third- and fourth-generation cephalosporins, aminoglycosides, and fluoroquinolones.

Figure 1: Common bacteria in hospitals (Pham Hong Nhung, report at Bach Mai Hospital, 2016)

Classification

   WHO has divided them into priority levels, namely critical, high, and medium, to express the level of urgency regarding antibiotics

   Among these, the critical priority group, which is also the common group accounting for a high proportion in Vietnam, usually consists of bacteria resistant to β-lactams (a class of antibiotics used to inhibit both gram-negative and gram-positive bacteria). These bacteria often carry mutated genes capable of producing antibiotic-hydrolyzing enzymes such as: 

• β-lactamases: Klebsiella pneumoniae Carbapenemase (KPC)
• Metallo-beta-lactamases (MBL), including:

-  New Delhi Metallo-beta-lactamase (NDM)

-  Verona Integron-encoded Metallo-beta-lactamase (VIM)

-  Imipenemase Metallo-beta-lactamase (IMP)

• Oxacillinase-48-like beta-lactamase (OXA-48)

ANTIBIOTIC RESISTANCE GENE TEST KIT

Intended Use:

   The kit is used to detect and differentiate the Klebsiella pneumoniae Carbapenem KPC/OXA-48 or MBL (VIM, IMP, NDM) antibiotic resistance genes of bacteria in the Enterobacteriaceae family and non-fermenting gram-negative bacteria (NFGNB) in many types of clinical samples using the Real-time PCR method.

   The kit is also the optimal option for:

• Retesting patients who have been prescribed drugs (after culture and antimicrobial susceptibility testing (AST) results are available) but whose condition has not improved and who do not respond to the drugs.
• Providing strong support for antimicrobial susceptibility testing when the AST shows susceptibility to only 1 antibiotic, when the AST shows no susceptible antibiotic, or when AST cannot be performed.

Sample Source:

   Various sample matrices: swabs, blood cultures, bacterial cultures, urine

Product Information:

Test kit for detecting and differentiating antibiotic resistance genes of the MBL (VIM, NDM, IMP) group

Test kit for detecting and differentiating antibiotic resistance genes of the K.pneumoniae Carbapenem KPC/OXA-48 group

KEY ADVANTAGES OF THE PRODUCT

   1. Certifications: CE-IVD, ISO 13485    2. Fast turnaround time (2-3h).     3. High accuracy, sensitivity, and specificity.    4. Detects and differentiates each group of antibiotic resistance genes.    5. Tests multiple genes per sample and multiple samples in 1 run.    6. Runs on many common Real-time PCR instruments.

Figure 2: Illustrative run results of the MDR KPC/OXA Real-TM kit on the Sacycler 96

CONCLUSION

   At its core, antibiotic resistance is mainly caused by the inappropriate or improper use of antibiotics, which creates conditions for drug-resistance mutations to form in the bacterial genome. Using the right drug at the right dose to precisely target the pathogen is currently the top priority for minimizing drug resistance in the community.

   Therefore, the root cause of the disease must be identified accurately and quickly. Using the Real-time PCR method to test for antibiotic resistance genes significantly speeds up the detection of bacterial infections and the identification of fast, effective treatments for patients.

   The MDR KPC/OXA Real-TM and MDR MBL (VIM, IMP, NDM) Real-TM (Sacace - Italy) reagent kits are distributed by VIET HUY Technological Scientific Equipment Co., Ltd, the exclusive representative of SACACE in Vietnam. The kits are currently used in many hospitals nationwide.

CONTACT ⁠INFORMATION

VIET HUY Technological Scientific Equipment Co., Ltd

   Address: 33 Nguyen Quy Canh, An Phu Ward, Thu Duc City, Ho Chi Minh City

   Email: info@viethuy.vn

   Web: www.viethuy.vn

   Phone: 028 6287 1596 / 99

REFERENCES

1. https://www.who.int/: WHO publishes list of bacteria for which new antibiotics are urgently needed

2. https://www.who.int/: WHO Antimicrobial resistance (who.int)

3. Article "Carbapenem-resistant enteric bacteria have a high carriage rate among inpatients and spread rapidly in hospitals" by Dr. Le Kien Ngai, Head of the Infection Control Department - Vietnam National Children's Hospital.