Introduction

In traditional workflows, completing a single pathogen detection requires multiple steps, including sample collection, nucleic acid extraction, PCR amplification, and result analysis. Among these, nucleic acid extraction is time-consuming and labor-intensive, often accounting for nearly half of the total testing time. This bottleneck is especially pronounced in emergency settings, primary healthcare, and large-scale screening scenarios, severely limiting testing efficiency and accessibility.

Breaking the Bottleneck: From Complex Extraction to Direct Release

Conventional nucleic acid extraction relies on magnetic bead–based or spin column–based methods, involving standardized steps such as lysis, binding, washing, and elution. These workflows are complex and require expensive equipment. A key question arises: is it possible to significantly simplify nucleic acid preparation while maintaining detection accuracy? Sample release reagent technology provides a breakthrough to this challenge and represents a critical shift in molecular diagnostics from complex extraction to direct amplification.

The core principle of sample release reagents lies in optimized combinations of surfactants, denaturants, and buffering systems. These formulations rapidly disrupt pathogen cell membranes or viral envelopes and denature proteins, enabling the release of nucleic acids into solution within minutes, while simultaneously inhibiting nuclease activity to protect nucleic acid integrity.

Hzymes’ HMD3508 is a sample release reagent specifically developed for rapid molecular testing scenarios. It eliminates the need for complex nucleic acid extraction, allowing released samples to be used directly in real-time quantitative PCR or LAMP assays.

Performance Evaluation Data

1. Comparison Between Release Reagent and Nucleic Acid Extraction

For influenza A and B targets, the performance of the release reagent is consistent with that of conventional nucleic acid extraction.

* Nucleic acid extraction was performed using 200 μL input and 100 μL elution (2× concentration). The theoretical Ct difference compared with the release reagent is 1.

2. Evaluation with Throat Swab Samples

Compared with a control release reagent, HMD3508 demonstrates better nucleic acid release efficiency from throat swab samples.

3. Evaluation with Blood Samples

Compared with dilution using TE buffer, HMD3508 shows superior release efficiency and stronger resistance to blood-derived inhibitors.

4. Room Temperature Stability of the Release Reagent

After sample collection, testing was performed following storage at room temperature for 3 hours and 6 hours. HMD3508 maintains more stable performance after 6 hours at room temperature.

5. Stability at 2–8 °C

After sample collection, testing was conducted following storage at 2–8 °C for 24, 40, and 48 hours. HMD3508 demonstrates more stable performance after 48 hours of storage at 2–8 °C.

Product Information