QIAGEN broadens syndromic testing menu in Malaysia with the MDA approval of advanced QIAstat-Dx respiratory panel

• The CE-IVD marked QIAstat-Dx Respiratory SARS-CoV-2 Panel is available in Malaysia expanded to 23 pathogens, now includes Chlamydophila pneumoniae

• Crucial during the Monsoon Season, providing comprehensive result for timely clinical decision-making and rapid therapeutic intervention

• QIAstat-Dx Respiratory SARS-CoV-2 Panel runs on higher-throughput QIAstat-Dx Rise enabling immediate urgent testing, with results in about an hour

Kuala Lumpur, Malaysia, June 04, 2024 – QIAGEN today announced the launch of improved version of QIAstat-Dx Respiratory SARS-CoV-2 Panel in Malaysia following the Medical Device Authority (MDA) approval. The CE-IVD marked QIAstat-Dx Respiratory SARS-CoV-2 Panel previously detected 22 pathogens, but the upgraded panel enables the detection up to 23 pathogens. The improved version is compatible with QIAstat-Dx Rise – a high-capacity version of the QIAstat-Dx automated syndromic system.

Influenza-like illnesses aren’t just caused by influenza viruses. There are many possible bacterial and viral causes that result in similar, overlapping symptoms. According to the World Health Organization (WHO), approximately 19,000 deaths due to respiratory infections were reported in Malaysia last year (1). The prevalence of infections typically increases during the monsoon season, as rainwater and stagnant pools become ideal breeding grounds for bacteria, thus elevating the risk of respiratory tract infections. The introduction of the QIAstat-Dx Respiratory SARS-CoV-2 Panel is a key step in combatting these health challenges, especially during critical weather periods.

QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid real-time PCR test intended for qualitative test for common pathogens that can present with influenza-like symptoms. This panel can now be used to detect and differentiate among 23 viral and bacterial targets that cause respiratory infections, including Chlamydophila pneumoniae.

“We are pleased to announce the availability of our QIAstat-Dx SARS-CoV-2 Respiratory Panel in Malaysia. The panel has been proven to be useful and crucial for emergency doctors to make an accurate diagnosis for patients presenting to the emergency department. The results give us a better understanding of the patient’s course of disease and enable us to formulate the best treatment plans for our patients,” said Dr. Justin Chai, Director of Medical Affairs at QIAGEN.

The test is available with the QIAstat-Dx system, designed for laboratory use, employs cost-efficient, single- use cartridges with built‑in sample processing and on-board reagents. Utilizing multiplex real-time PCR, it detects and differentiates between multiple pathogens, with results in about an hour. QIAstat-Dx system provides rapid and accurate results, ensuring healthcare providers to make informed clinical decisions quickly, initiating appropriate therapeutic interventions without delay. This is particularly vital in managing the spread and impact of upper respiratory tract infection (URTI).

QIAstat-Dx system connects to the QIAsphere cloud-based platform that provides remote monitoring of the instruments and test status, allowing customers to receive push notifications on their personal devices. It can monitor an unlimited number of instruments across different hospitals or satellite labs, reducing system downtime and enabling fast and accurate syndromic testing.

QIAsphere Insights dashboard shows greater pathogen diversity in respiratory illness in 2023. SARS-CoV- 2 made up fewer than 10% of positive detections. In contrast, Rhinovirus/Enterovirus accounted for the largest share at 34.2%, and there was an increase in bacterial detections, including L. pneumophila (0.1%), pneumoniae (0.8%) and B. pertussis (0.9%). Carefully examining the historical record of respiratory pathogen positivity rates in a lab or hospital can be an initial step in understanding recurring infections, pathogen diversity and this allows for precise antibiotic treatment.

QIAstat-Dx solutions and syndromic tests supporting disease diagnosis are available in more than 100 countries worldwide. Instruments had been placed in various hospitals, including Ministry of Health of Malaysia, with the first installation in 2019. QIAstat‑Dx is available in two formats: the QIAstat-Dx Analyzer version, which integrates up to four Analytical Modules, and the QIAstat-Dx Rise higher-capacity version, providing comprehensive testing for up to 160 tests per day using eight Analytical Modules.