Current Situation
1. Disease Status: Candidiasis is more prevalent in immunocompromised patients, which can invade local skin, mucous membranes, as well as various tissues and organs throughout the body, with diverse clinical manifestations and varying severity. With the increase of risk factors such as the extensive application of tumor chemotherapy, organ transplantation, glucocorticoids, immunosuppressants and broad-spectrum antibacterial drugs, the incidence of invasive candidiasis has shown a significant upward trend. According to statistics, invasive candidiasis has the highest mortality rate among invasive fungal diseases, with a mortality rate of 46%~75% and an attributable mortality rate of 10%~49%. On October 25, 2022, the World Health Organization (WHO) issued the first Fungal Priority Pathogen List (FPPL) for Invasive Fungal Diseases (IFDs), which includes Candida albicans, Candida tropicalis, Candida glabrata, Candida parapsilosis and Candida krusei, reflecting international attention to fungal infections. The diagnosis of invasive candidiasis is difficult, and the condition is severe, progresses rapidly and has a poor prognosis. Therefore, it is very necessary to establish a rapid diagnostic method for the timely control or prevention of the occurrence and development of invasive candidiasis.
2. Disadvantages of Traditional Solutions: At present, traditional fungal detection methods such as direct microscopy, culture and serological testing have low sensitivity and specificity, low detection rate and long reporting cycle, making it difficult to be used for early detection. Fully automated microbial identification systems can accurately identify hundreds of pathogenic fungi, with simple operation and faster speed (about 6 hours) compared with culture methods, but have disadvantages such as high cost of equipment and consumables. The mass spectrometry method developed in recent years also faces the problem of expensive equipment, and at the same time has low throughput, which cannot realize simultaneous detection of a large number of samples.
iFIND Solution
1. Advantages of the Cartridge
This reagent cartridge is integrated with the iFIND instrument adopting real-time fluorescence technology to realize automatic purification of samples, nucleic acid amplification, and detection of target sequence determination in single or complex samples. The cartridge is equipped with ultrasonic extraction buffer and amplification reagents. Through integrated detection, the integration of sample nucleic acid extraction and detection is realized to determine whether Candida albicans, Candida tropicalis, Candida glabrata, Candida parapsilosis and Candida krusei exist in the samples. All reactions of this kit are carried out in the cartridge. Due to the good sealing performance of the cartridge itself and independent reactions between various chambers, contamination can be effectively prevented; at the same time, endogenous internal standards are used as the quality control system, and the whole-process quality control is monitored through internal standards for the collection, transportation, extraction and detection processes of the tested samples to avoid false negative results.
2. Purpose and Significance of the Cartridge
Rapid Diagnosis: Rapid and accurate detection of Candida, with results available within 1 hour, helping medical staff to timely detect infections and take treatment measures.
Risk Reduction: High-sensitivity detection of low-level infections, reducing misdiagnosis and missed diagnosis, lowering the incidence of complications, and improving the cure rate and survival rate of patients.
Clinical Value: Early diagnosis of Invasive Candidiasis (IC), timely treatment can significantly improve the prognosis, and delayed treatment may lead to a substantial increase in mortality. In addition, the cartridge can determine the specific type of infection, which is crucial for selecting appropriate antifungal drugs and formulating treatment plans.