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RainSure Digital PCR Malaria Detection Solution: A Cutting-Edge Approach for Rapid and Quantitative Plasmodium Identification

Views: 0     Author: Denise Ho     Publish Time: 2024-02-02      Origin: Site


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RainSure Digital PCR Malaria Detection Solution: A Cutting-Edge Approach for Rapid and Quantitative Plasmodium Identification

As the traditional Chinese New Year approaches and the Spring Festival unfolds, global travelers returning home have initiated a surge in crowd mobility, increasing the risk of respiratory infections. Simultaneously, the rise in returnees has heightened the threat of imported malaria. Various domestic CDC departments have reported a growing number of imported malaria cases, prompting issuing documents to reinforce malaria prevention during the holiday season.

Recent Case Reports and CDC Notifications Timeline

·       January 18: Yantai CDC identifies a rare mixed Plasmodium falciparum and Plasmodium ovale infection case.

·       January 19: Huizhou CDC reports an imported case of malignant abuse infection.

·       January 19: Jiangsu Xuzhou CDC issues an urgent reminder for returnees to be vigilant against imported malaria.

·       January 28: Beijing CDC emphasizes the need to beware of malaria during holiday travels.

·       January 30: Luoyang CDC reports falciparum malaria cases among returnees.

·       January 31: Chongqing CDC stresses returnees’ attention to malaria prevention.

Malaria: A Global Health Concern

Malaria, recognized alongside AIDS and tuberculosis, remains a major threat despite the country’s certification for malaria elimination in 2021. According to the latest WHO World Malaria Report, there are approximately 241 million global malaria cases, resulting in 627,000 deaths.

Early symptoms of malaria, often mistaken for influenza, can lead to severe consequences if not promptly treated. With symptoms including fever, headache, and chills, rapid progression to severe malaria within 24 hours is possible if left untreated.

In December 2023, Taiwan reported a malaria-related death, underscoring the ongoing threat. A male traveler, who did not take malaria prophylaxis during his visit to Nigeria, exhibited symptoms including fever, chills, and signs of severe illness upon returning to Taiwan. The case was diagnosed with falciparum malaria on December 1. Unfortunately, the individual’s condition rapid deteriorated, resulting in multiple organ failure and, ultimately, death.

To address this challenge, RainSure Scientific introduced the RainSure Digital PCR Quantitative Detection Kit for four Plasmodium species in 2021. This advanced solution allows for early infection screening, real-time treatment monitoring, and discharge assessment, ensuring high sensitivity and accuracy.


Validation and Superiority

RainSure’s malaria testing solution has been embraced by hospitals, CDC departments, and research institutes. A study conducted at Huashan Hospital, affiliated with Fudan University, validated its superiority over traditional methods. The study involved the examination of 39 positive patients (confirmed through microscopic examination) spanning from 2016 to 2021, 20 healthy individuals, and 6 patients with other blood parasite infections. Whole blood samples were scrutinized using both traditional blood smears and RainSure’s digital PCR (dPCR) technology, affirming the effectiveness of the multiplex malaria rapid test protocol developed by RainSure Scientific.

The RainSure dPCR system demonstrated its capacity for rapid diagnosis and quantification of malaria DNA samples. With an analytical sensitivity as low as 0.557 copies/μL (95% CI 0.521-0.607), the system exhibited a remarkable 98% sensitivity and 100% specificity for clinical samples. Notably, the dPCR system identified three cases of multiple malaria co-infections, including one instance of triple malaria infection.

A significant aspect of the study involved monitoring the efficacy of drug therapy through consecutive daily blood samples from a specific patient (Patient 39). The dPCR results revealed real-time changes in Plasmodium falciparum DNA concentrations, ranging from 5474 copies/μL-0 copies/μL, reflecting the effectiveness of antimalarial drugs.

This study further highlighted the enhanced malaria detection capacity of blood samples (with plasma removed) over whole blood. These findings, emphasizing the advantages of dPCR over traditional optical microscopy, were published in Clinica Chmica Acta with an impact factor of 6.314.


The effectiveness of RainSure’s digital PCR method was also spotlighted in a news story by Medical Voice Medicine during the Chinese New Year in 2022. On November 5, 2021, a male individual returned to Shanghai from Africa. Upon completing 14 days of centralized isolation, the individual was preparing to return home when an abrupt onset of symptoms, including chest tightness, fatigue, led to a fainting episode, prompting immediate admission to the hospital. Subsequent examinations, encompassing antibody test, blood CRP, liver and kidney function assessments, chest CT scans, electrocardiograms, and other related diagnostics, revealed alarming health indicators. The findings pointed to an abnormal increase in white blood cells, low platelet counts, severe liver function damage, and acute renal failure, categorizing the patient's condition as critically urgent.

Upon admission to the isolation ward, an additional Plasmodium antigen test suggested the presence of Plasmodium falciparum infection. Subsequently, utilizing RainSure’s digital PCR malaria test kit, the medical team accurately identified a mixed infection of Plasmodium falciparum and Plasmodium ovale. Timely and precise treatment, guided by the dPCR results, prevented the deterioration of the patient’s condition, ultimately leading to a successful recovery within 48 hours.


In summary, RainSure’s digital PCR method proves to be a groundbreaking and precise tool in malaria diagnosis and treatment, offering superior sensitivity and real-time monitoring capabilities. The successful application of this technology in critical cases underscores its potential to revolutionize malaria detection, contribute to effective treatment strategies, and significantly impact global health outcomes.

Advantages of RainSure Digital PCR Method


Giemsa Staining of Malaria

Blood Films

Real-time PCR

Digital PCR

False Negative Rate


Moderately high


Blood Collection Window Control Requirements


Moderately high


Operator's Professional Level Requirements


Moderately high


Testing Process




Target Detected/Reaction

1 target/reaction

1-2 targets/reaction

Multiple targets/reaction




Absolute quantification





Turnaround Time (TAT)

1 hour

2-3 hours

2-3 hours

RainSure’s Digital PCR method outperforms traditional detection methods. Compared to blood smear examination, it offers low false-negative rates, simplified testing processes, and absolute quantification. The DropDx and DropX series of digital PCR systems, endorsed by major certifications such as NMPA, FDA-EUA, and CE-IVDR, distinguish themselves through high sensitivity, stability, and reproducibility.

These platforms feature a multiplexed fluorescence design, facilitating simultaneous detection of multiple targets within a single sample. This not only optimizes clinical testing workflows by minimizing sample consumption, reagent usage, and testing time, but also enhances the efficiency of detecting low-level malaria infections. The systems, adept at diagnosing mixed infections and enabling continuous multi-sample monitoring, seamlessly integrate with rapid adjustment of treatment strategies. This integration proves instrumental in curbing the overuse of various drugs and mitigating the risk of potential drug resistance.

The widespread adoption of RainSure's digital PCR method is poised to advance Plasmodium detection, contribute significantly to drug resistance research, and pave the way for individualized and precise treatment. This transformative approach not only promises to elevate malaria prevention and control efforts to new heights but also instills confidence in humanity’s pursuit of eradicating malaria completely.


About RainSure Scientific

Dedicated to precision diagnostics, RainSure Scientific is a forward-thinking company that focuses on innovative diagnostic platforms and life science solutions. With a team of Ivy League graduates and industry veterans, RainSure aims to empower customers through innovative technology and intelligent manufacturing. The company has successfully pioneered world-leading scientific instruments and molecular diagnostic products through continuous expertise accumulation in microfluidics and intelligent manufacturing. This includes cutting-edge microfluidics research platforms, state-of-the art digital PCR systems, and comprehensive supporting kits.



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