Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)

Product Information

Detection Target: Aspergillus species, Cryptococcus neoformans, Pneumocystis jirovecii, Mucorales and Talaromyces marneffei.

Cat. No. : 10T/box – 10210111A; 50T/box – 10210111B

The iFIND Five Invasive Fungal Nucleic Acid Detection Kit is a multiplex real-time PCR assay for the simultaneous detection of five clinically significant fungi in a single tube: Aspergillus species, Cryptococcus neoformans, Pneumocystis jirovecii, Mucorales, and Talaromyces marneffei. It is intended for patients at high risk of invasive fungal infections, including those with immunocompromised conditions or clinical suspicion of fungal disease.

Five Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)

Current Situation

1. Global and Domestic Status of the Disease: Invasive Fungal Disease (IFD) is a category of infectious diseases caused by various fungi. With the widespread use of immunosuppressants and the emergence of immunodeficiency disorders such as AIDS, the incidence of IFD has been on the rise globally. A 2022 study showed that the incidence of invasive fungal infections among ICU patients in China is approximately 10%. Additionally, *Cryptococcus neoformans* infections are common worldwide, particularly among AIDS patients with a high incidence rate. IFD primarily affects immunocompromised patients, including those with hematological malignancies, organ transplant recipients, critically ill patients in intensive care units, patients with chronic obstructive pulmonary disease, and diabetic patients. Due to impaired immune systems, these patients are more susceptible to fungal infections, which progress rapidly and have a high mortality rate.
2. Disadvantages of Traditional Solutions: Diagnostic Difficulties: Traditional diagnostic methods include microscopy, fungal culture, and serological testing, but they suffer from low sensitivity, poor specificity, and long detection cycles. For example, fungal culture may take days or even weeks to yield results and is prone to false negatives.
Treatment Delay: The limitations of traditional diagnostic methods make early diagnosis of invasive fungal infections difficult, leading to delayed treatment and increased patient mortality risk. Studies indicate that each 1–2 day delay in treating invasive aspergillosis may double the mortality rate.
High Mortality: IFD is associated with a high mortality rate, especially in immunocompromised patients. The inadequacies of traditional diagnostic methods hinder early intervention, resulting in poor patient prognosis.

iFIND Solution

1. Advantages of the Cartridge: High Sensitivity and Specificity: Adopting quantitative real-time PCR (qPCR) technology, the cartridge can detect low concentrations of fungal nucleic acids with high sensitivity and specificity. This enables the kit to identify low-level infections that may be missed by traditional culture methods, improving diagnostic accuracy. The cartridge is equipped with an endogenous internal standard to monitor the entire process of sample collection, transportation, extraction, and detection, preventing false-negative results, ensuring the reliability of test outcomes, and reducing misdiagnosis;
2. Purpose and Significance of the Cartridge: It can rapidly determine the presence of clinically common deep fungal pathogens in samples, including *Aspergillus*, *Cryptococcus neoformans*, *Pneumocystis jirovecii*, *Talaromyces marneffei*, and *Mucor*. This is particularly critical for immunocompromised patients such as those with hematological malignancies and organ transplant recipients, who are highly vulnerable to deep fungal infections with rapid disease progression.
Assisting Clinical Decision-Making: It provides clinicians with rapid and accurate diagnostic information to promptly detect infections and implement targeted treatment measures. This is vital for reducing the incidence of complications caused by deep fungal infections and improving patient cure and survival rates.
Reducing Mortality: Early diagnosis and timely treatment are essential for lowering the mortality of deep fungal infections. Research shows that each 1–2 day delay in treating invasive aspergillosis may double the mortality rate. The rapid detection capability of this kit significantly shortens the diagnostic window, thereby improving patient prognosis.
Enhancing Diagnostic Accuracy: The high-sensitivity and high-specificity design allows the kit to detect low-level infections missed by traditional culture methods, minimizing misdiagnosis and missed diagnoses and boosting overall diagnostic accuracy.