Recently, ten pathology staining solutions and auxiliary reagents developed by our company have successfully obtained Class I medical device filing certificates issued by the National Medical Products Administration (NMPA). The successful filing of this product series signifies a significant expansion of our product portfolio in the field of pathology diagnostic reagents, elevating our technological R&D and quality management systems to new heights. This advancement will provide more comprehensive and precise pre-processing solutions for clinical pathology diagnosis.

The ten registered products are all core reagents for routine pathology laboratory work, covering multiple critical steps including routine staining, special staining, and cytological examination. Specifically, these include: Cell Fixative, Sudan Black Stain, Perjovschi's Iodine-Periodate Stain, Alcian Blue-Periodate-Schiff Stain (AB-PAS), Congo Red Stain, Capsular Stain, Hematoxylin-Eosin (HE) Stain, Fuchsin-Eosin (F-E) Stain, Nucleic Red Stain, and Spore Stain.

Each of these products serves distinct purposes in clinical pathology diagnosis, with specific clinical applications and diagnostic significance as follows:

Cell Preservation Solution: Primarily used for collecting, fixing, and preserving samples such as cervical exfoliated cells, serous cavity effusions, urine, and sputum. Its core significance lies in maintaining cellular morphological integrity, preventing autolysis and putrefaction, and providing a high-quality sample foundation for subsequent Papanicolaou staining and liquid-based cytology examinations. It serves as the primary safeguard for cervical cancer screening and various exfoliative cytology diagnoses.

Sudan Black Stain: Primarily used to visualize intracellular lipid substances including neutral fats, phospholipids, and sterols. In hematology diagnostics, it aids in distinguishing acute myeloid leukemia (often positive) from lymphocytic leukemia. In pathology, it helps differentiate lipid-rich tumors such as liposarcoma and adrenal cortical tumors.

Schiff's Iodine-Acid Fuchsin Stain: Used to visualize glycogen, neutral mucopolysaccharides, mucins, and glycoproteins within tissues (appearing red). Widely applied in the diagnosis and differential diagnosis of gastric carcinoma (signet ring cell carcinoma), hepatocellular carcinoma, prostate cancer, rhabdomyosarcoma, Ewing's sarcoma, etc. In renal pathology, it visualizes glomerular basement membranes, aiding in diagnosing conditions like diabetic glomerulosclerosis.

Alcian blue-Schiff peroxymonosulfate solution: Simultaneously distinguishes neutral mucins (PAS-positive, red) and acidic mucins (AB-positive, blue). Its core significance lies in classifying gastrointestinal metaplasia (complete vs. incomplete), serving as a vital tool for determining gastric mucosal intestinal metaplasia types and assessing gastric cancer risk. It is also used for differential diagnosis of mucinous tumors in salivary glands, lungs, ovaries, cervix, and other sites.

Congo Red Stain: Specifically binds to amyloid substances, producing characteristic apple-green birefringence under polarized light. This staining serves as the “gold standard” for diagnosing amyloidosis, crucial for confirming systemic amyloidosis (involving heart, liver, spleen, kidneys) or localized amyloid deposits. It also forms the basis for distinguishing different amyloidosis subtypes, such as AL and ATTR types.

Capsular stain: Used to visualize bacterial or fungal capsules (typically staining the cell body while the capsule appears as a transparent halo). It plays a critical role in diagnosing infectious diseases like cryptococcal meningitis (Neocryptococcus) and Klebsiella pneumoniae pneumonia, rapidly indicating the presence of specific pathogens.

Hematoxylin-Eosin Stain: As the most fundamental and widely applied routine staining method in pathological diagnosis, it is regarded as the “gold standard” of pathology. It clearly displays the basic morphological structures of cell nuclei (blue) and cytoplasm/interstitial tissue (red), serving as the cornerstone for all histopathological examinations. It is used for the preliminary diagnosis of nearly all diseases, distinguishing benign from malignant tumors, and assessing inflammation.

Cresyl Violet-Eosin Stain: Primarily used for staining gastric mucosal biopsy specimens. It clearly displays Helicobacter pylori (appearing blue or black) and the cellular structure of the gastric mucosa. Its diagnostic significance lies in the direct and rapid identification of H. pylori infection, serving as direct evidence for evaluating the etiology of chronic gastritis and peptic ulcers.

Nucleus Orange Stain: Often used as a counterstain for various special stains (e.g., VG staining, elastic fiber staining) to enhance nuclear visibility. It provides clear nuclear background contrast in cardiovascular pathology (e.g., vascular wall structure observation), cirrhosis (showing sclerotic nodules), and certain bone tissue stains, aiding precise interpretation.

Spore Stain: Used to distinguish bacterial vegetative forms from spores (spores stain, while cells remain colorless or pale). Primarily applied in microbiological identification, it aids in the etiological diagnosis of suspected infections caused by spore-forming bacteria such as Clostridium species (e.g., Clostridium tetani, Clostridium perfringens).

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