The Dilemma of Infectious Diseases & Conventional Testing 

According to statistics from the World Health Organization (WHO), infectious diseases account for over 25% of global deaths, especially in populations vulnerable to conditions like sepsis, meningitis, pneumonia, and immunocompromised states, with even higher mortality rates. However, using existing conventional pathogen detection methods, the detection rate in these populations is only 30-50%, and each method has its limitations. This leads to clinical practitioners being unable to confirm the pathogen early, relying only on past experiences or empiric antibiotic treatment, which delays optimal diagnosis and treatment for critically ill patients. Recognizing the current testing dilemma, APG offers a scientific solution: "APGseq - Clinical Metagenomic Sequencing Service"!

APGseq

"In simple terms, if PCR is a fishing rod, mNGS is a fishing net!"

APGseq is a comprehensive, accurate, and rapid infectious pathogen gene sequencing test service based on Metagenomic Next next-generation sequencing (mNGS) technology. Utilizing high-throughput sequencing depth along with APG's unique pathogen database can surpass the limitations of traditional clinical testing, performing sequencing analysis of thousands of pathogens in patient samples at once. Within 48 hours, it provides test reports, identifying the causative pathogen and assisting clinical practitioners in diagnosis and formulating the best treatment plan. The key differences from conventional testing lie in its lack of need for culture, no assumptions, and the ability to test for thousands of pathogens at once, making it a non-culture-based infection testing method. "Infections are acute diseases! Unlike chronic diseases, they can't be adjusted slowly!" APGseq's highly efficient testing service ensures that acute (rapid progression of the disease), severe (life-threatening conditions), and difficult (hard to diagnose) infection patients do not miss the golden treatment window and can receive the most accurate diagnosis and treatment on time.

Product Advantages:

Comprehensive： Able to Detect 27,000 types of Pathogens (Bacteria, Fungus, Viruses, Parasite) in under a Single Test

Precise： Compared to Conventional Microbiology Methods, able to increase in 62 % Positive Pathogen Detection Rate

Efficient： Provide Report within 24-48 hrs. to Assist Physicians in Time for Making Clinical Decisions

Product Specification：

Reads refers to the number of sequence fragments read and generated by the sequencer. It is positively correlated with detection sensitivity — the larger the reads, the higher the sensitivity.

What kind of patients are suitable for this test? 

Patients diagnosed by clinicians as having infections and in need of testing, such as those with rapidly progressing sepsis, severe illness, or cases where conventional pathogen diagnostics are challenging.

What are the methods and procedures for this test?

The APGseq test consists of five steps:

1. Extraction: Extract all nucleic acids from the patient’s sample.
2. Library Preparation: Using the Shotgun method, fragmentize all obtained nucleic acids and assign identifiable tags.
3. Sequencing: Utilize a sequencer with optical detection to sequence the prepared nucleic acid fragments, generating sequencing data.
4. Analysis: Analyze the sequencing data using bioinformatics analysis and match it against pathogen databases to identify which sequences may correspond to infectious pathogens.
5. Reporting: Clinical laboratory technician will review the analysis of potential pathogens and generate a final report for review by the designated physician.

How to submit a sample and what is the submission process? 

1. Consult with your attending physician to determine the appropriate testing specifications.
2. The physician will identify the infection site, and relevant departments will collect the appropriate sample (e.g., blood, bronchoalveolar lavage fluid, or tissue).
3. The test will be outsourced to an accredited external laboratory (Laboratory Developed Tests and Services, license number LDT0014). Samples will be sent to the Asia Pathogenomics Medical Laboratory (Address: 9F-12, No. 93, Section 1, Xintai 5th Road, Xizhi District, New Taipei City) for analysis.
4. Turnaround time: Starting from the receipt of the sample at the accredited laboratory, a laboratory version of the test report will be provided to the institution within 3 working days for review by the designated physician.
5. After the physician’s review, an internal report version will be issued to the attending physician and relevant requesting departments.

Are there any risks associated with the test?

(No medical procedure is risk-free; known risks are listed below, while some unforeseen risks may not be included.)

1. The detection limit varies by pathogen type, approximately ranging from 1 to 678 cells per 500 mL. Microorganisms below this detection limit may not be identified.
2. A negative result in the report does not rule out the possibility of infection by a pathogen, especially if it is outside the test's detection range.
3. The use of antibiotics can reduce the microbial load in the sample, potentially affecting the detection rate. If the patient has already started anti-infective treatment before or during sample collection, it is essential to communicate this with the attending physician, as it may impact pathogen detection.
4. Due to the principles of the test, current technological limitations, and individual patient differences, there may still be cases where pathogens are not detected or the test may fail, even with strict adherence to procedures in hospitals or accredited laboratories.
5. Although nucleic acid testing is highly accurate, rare errors may still occur.
6. In some cases (e.g., insufficient sample volume, clotting, hemolysis, etc.), incorrect sample collection sites, or nucleic acid extraction yielding lower-than-recommended amounts, there may be detection issues, potentially requiring a repeat sample.
7. This test result should not be used as the sole basis for diagnosis, treatment, or other medical decisions. Pathogens detected by this test may not always be the actual cause of infection. Other tests may also be required for a comprehensive assessment, with final clinical decisions made by the attending physician.

How to interpret the report?

To protect patient safety under medical regulations, our laboratory responsibility is limited to generating the report. Only the attending physician can professionally interpret the report’s results. Any explanation of the report, as well as further treatment plans, please discuss with your attending physician.