As we approach the close of 2025, we are thrilled to announce that our company's independently developed eight Class I medical device in vitro diagnostic reagents have officially received filing approval! These products—including α-Acetylnaphthol Beta-D-Glucosidase (α-NAE) staining solution, α-Butyrophenol B esterase (α-NBE) staining solution, Alcian blue staining solution, flagella staining solution, phosphotungstic hematoxylin staining solution, lactate cotton blue staining solution, Sirius red staining solution, and reticulin staining solution—signify a major breakthrough for our company in the field of precision medicine. As in vitro diagnostic reagents, they cover five core domains: hematopathology, microbiology, neuropathology, tumor diagnosis, and fibrosis assessment, significantly enhancing the accuracy and efficiency of clinical testing. This approval not only demonstrates technological prowess but also actively responds to the “Healthy China 2030” strategy. Below, we systematically elaborate on the clinical significance and core applications of these reagents, showcasing their innovative value.

I. The “Dynamic Duo” in Hematopathology Diagnostics: α-NAE and α-NBE Staining Solutions

α-Acetylnaphthol Acetylesterase (α-NAE) Staining Solution

Clinical Significance: By detecting intracellular nonspecific esterase activity, this reagent serves as the “gold standard” for acute leukemia classification. Its core function lies in distinguishing monocytes from granulocytes: monocyte lineages (e.g., promonocytes, monocytes) exhibit strong positive reactions (brown-red granules) that can be inhibited by sodium fluoride; granulocyte lineages remain unaffected, a characteristic directly linked to the biological behavior of leukemia subtypes.

Core Application: Primarily used to differentiate acute myeloid leukemia-monocytic (AML-M5) from acute myeloid leukemia-myeloid (AML-M2/M3), and to assist in diagnosing myelomonocytic leukemia. The sodium fluoride inhibition test must be performed concurrently to ensure high specificity, providing reliable evidence of cellular differentiation for clinical practice.

‌α-N-Butyryl-Naphthol Esterasy (α-NBE) Stain‌

‌Clinical Significance‌: As a dedicated “probe” for the monocyte-macrophage lineage, this reagent offers irreplaceable detection of esterase activity. Its clinical significance lies in: acute monocyte leukemia cells exhibit strong positivity (red precipitate) and are completely inhibited by sodium fluoride; whereas hairy cell leukemia cells show diffuse positivity without inhibition, providing a molecular-level “fingerprint” for leukemia classification.

Core Application: Used to confirm acute monocytic leukemia diagnosis, differentiate from other leukemias (e.g., lymphoid tumors), and assess monocyte differentiation status. Its high color contrast and clear background make it a standard tool in pathology laboratories.

II. Histochemical Multitaskers: Alcian Blue, PTAH, and Reticulum Stain Solutions

Alcian Blue Stain Solution

Clinical Significance: Specializes in the qualitative and typological analysis of acidic mucopolysaccharides and mucins, earning its reputation as the “microscope” for tumor mucin analysis. Its significance lies in specifically binding negatively charged sulfated and carboxylated mucopolysaccharides. Through pH regulation (pH 2.5 stains carboxylated mucins, pH 1.0 stains sulfated mucins), it reveals the molecular characteristics of lesions.

Core Applications: Distinguishes mucinous from non-mucinous subtypes in gastrointestinal adenocarcinomas; evaluates mucin deposition in chondropathies or myxomas; frequently combined with PAS staining (AB-PAS) for dual identification of acidic and neutral mucopolysaccharides, enhancing tumor diagnostic accuracy.

‌Phosphotungstic Acid Hematoxylin (PTAH) Stain‌

‌Clinical Significance‌: As a “structural painter” for neural and muscular tissues, this reagent exhibits strong affinity for glial fibers, nuclei, and striated muscle, yielding high-contrast staining. It serves as a vital complement to HE staining.

Core Applications: In neuropathology, it clearly delineates neuronal nuclei and glial fibers for evaluating brain tumors (e.g., gliomas) and neurodegenerative diseases (e.g., Alzheimer's disease). It also aids in distinguishing rhabdomyosarcoma (characterized by blue-purple striations in muscle fibers), providing therapeutic guidance.

‌Reticular Fibre Stain‌

‌Clinical Significance‌: Serves as a “transparent lens” for tissue architecture, where its distribution directly reflects microstructural integrity. Clinically significant for assessing tumor invasiveness: reticular fibre enveloping cancer cell nests or showing disruption is key for distinguishing benign from malignant tumors.

Core Applications: Distinguishing carcinoma from sarcoma (continuous envelopment in carcinoma vs. scattered fibers in sarcoma); differentiating carcinoma in situ (intact basement membrane) from invasive carcinoma (ruptured basement membrane); evaluating cirrhotic nodules in liver pathology; and classifying ovarian tumors (e.g., granulosa cell tumors), offering superior value over routine staining.

III. “Innovators” in Microbial and Fibrosis Diagnosis: Flagella, Lactate Cotton Blue, and Sirius Red Staining Solutions

Flagella Staining Solution

Clinical Significance: Serves as a “morphological compass” for bacterial classification by visualizing flagella morphology (number, location, length), revealing pathogen species characteristics and motility potential.

Core Applications: Rapidly identifies Vibrio cholerae (monopolar flagella), Salmonella spp. (peritrichous flagella), and Helicobacter pylori (multifilar flagella), aiding pathogenicity assessment; suitable for initial screening of clinical isolates and epidemiological tracing. Requires fresh specimens to ensure flagellar integrity.

Lactic Acid Cotton Blue Stain Solution

Clinical Significance: The “permanent archivist” of mycology, enhancing optical contrast between hyphae and spores for long-term preservation, addressing the issue of fading in clinical specimens.

Core Applications: Used in mycology laboratories for fungal identification in skin, nail, or sputum samples (e.g., Aspergillus, Mucor); stained slides can be preserved for years, supporting teaching, research, and case archiving; Enables clear observation of hyphal septa and spore morphology under high magnification.

Sirius Red Stain Solution

Clinical Significance: The “gold standard quantifier” for collagen fibers. Combined with polarized light, it distinguishes Type I collagen (strong birefringence, red/yellow) from Type III collagen (weak birefringence, green), reflecting fibrosis maturity.

Core Applications: Quantitative assessment of liver fibrosis (cirrhosis), renal interstitial fibrosis, and pulmonary fibrosis severity; analysis of collagen organization in scar tissue; essential tool for tumor microenvironment research and preclinical drug evaluation.

Conclusion: Pioneering a New Era of Precision Diagnostics

The eight newly approved reagents represent not only technological advancements but also multidimensional solutions for clinical diagnostics. With high specificity and stability, they empower pathology, microbiology, and oncology, projected to boost testing efficiency by over 30% while reducing misdiagnosis rates. Looking ahead, our company will pursue continuous innovation, deepen the “diagnosis-as-treatment” philosophy, and contribute Chinese wisdom to global health. Let us celebrate this milestone together and jointly pioneer a new chapter in precision medicine!