Sacace Biotechnologies was founded in 2001 and specializes in the development and production of more than 140 comprehensive diagnostic kits used in human disease diagnostics, veterinary disease detection, and food safety testing. These kits include complete reagent systems for nucleic acid extraction, amplification of specific genetic regions (PCR or RT-PCR), and detection of amplification products.With strong in-house R&D capabilities and modern manufacturing facilities, Sacace provides molecular diagnostic solutions covering a wide range of pathogens for human healthcare, veterinary medicine, and the food industry, enabling accurate screening and detection. All kits contain the full set of reagents required for nucleic acid extraction, reverse transcription, amplification of specific genomic regions, and real-time fluorescent PCR detection.The products feature user-friendly designs and have obtained CE-IVD certification, complying with European regulatory requirements. Carefully selected high-quality reagents ensure consistent, reliable results and extended shelf life. The entire manufacturing process is certified under ISO 13485:2016, the international standard for medical device quality management systems.Major product lines include SARS-CoV-2 real-time PCR detection kits, Hepatitis C/Hepatitis B diagnostic kits, Human Papillomavirus (HPV) detection kits, Chlamydia trachomatis detection kits, Mycobacterium tuberculosis (MTB) detection kits, and Toxoplasma gondii detection kits.

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Vicbio Biotechnology Co., Ltd. provides the full range of Sacace Biotechnologies products.

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1. Hepatitis Virus Detection Kits

HCV RNA / HBV DNA CE-IVD PCR Kits are designed for the detection of hepatitis viruses. Hepatitis viruses represent a group of infectious diseases caused by hepatotropic viruses from different families. There are five major types, classified into two categories: enteric viruses (Hepatitis A and E) and parenterally transmitted viruses (Hepatitis B, C, and D). The Hepatitis C virus (HCV) targeted by these kits is an RNA-containing hepatotropic virus belonging to the Flaviviridae family. Acute HCV infection is often asymptomatic or presents with mild symptoms, but approximately 80% of cases progress to chronic infection, with 15–20% developing liver cirrhosis and an annual 1–4% risk of hepatocellular carcinoma.Hepatitis B virus (HBV) is a DNA virus belonging to the Hepadnaviridae family. Currently, approximately 500 million people worldwide are infected with HBV.

2. Human Immunodeficiency Virus (HIV) Detection Products

These products generally employ real-time quantitative polymerase chain reaction (qPCR) technology. Specific primers and probes targeting HIV genomic regions such as gag, pol, and env are used. During PCR amplification, probes hybridize with target sequences and are cleaved during the reaction, releasing fluorescent signals. By monitoring the intensity and timing of fluorescence signals, quantitative detection of HIV nucleic acids can be achieved.

Product Advantages

•High Sensitivity: Capable of detecting extremely low concentrations of HIV nucleic acids, enabling early diagnosis, especially during the serological window period.

•High Specificity: Precisely recognizes HIV genetic sequences, minimizing cross-reactivity with other viruses and reducing the likelihood of false-positive results.

•Quantitative Detection: Accurately determines viral load, which is critical for monitoring disease progression and evaluating antiviral treatment efficacy. Regular viral load monitoring helps clinicians assess treatment effectiveness and adjust therapeutic strategies when necessary.

•International Compliance: CE-IVD certified and compliant with European in vitro diagnostic medical device regulations, allowing distribution and use in Europe and other CE-recognized regions.

3. Human Papillomavirus (HPV) Detection Products

These products are based on PCR amplification combined with gene chip technology or fluorescent probe detection. Specific HPV gene fragments, such as the L1 gene, are amplified by PCR and then hybridized with specific probes on a gene chip or fluorescent probe system. HPV genotypes are determined based on hybridization signals.

Product Advantages

•Comprehensive Genotyping: Detects multiple HPV genotypes, including high-risk types (e.g., HPV16, 18, 31, 33) and low-risk types (e.g., HPV6, 11). Persistent infection with high-risk HPV is strongly associated with cervical cancer and other malignancies.

•Accurate Diagnosis: Provides precise HPV infection information to support personalized clinical management and screening strategies.

•Ease of Operation: Optimized kit design simplifies workflows, minimizes human error, and improves the reliability of test results.

4. Sexually Transmitted Disease (STD) Multiplex Detection Products

These products utilize multiplex PCR technology, enabling simultaneous amplification of specific genetic fragments from multiple STD pathogens within a single reaction system. Different primers and probes allow for the simultaneous detection and differentiation of multiple pathogens.

Product Advantages

•High Efficiency: Simultaneous screening for multiple STD pathogens in a single test, saving time and reducing costs.

•Rapid Diagnosis: Shortened testing cycles enable patients to receive timely diagnosis and treatment, helping to reduce disease transmission and complications.

•High Accuracy: Multiplex PCR provides high sensitivity and specificity, ensuring reliable clinical diagnostic results.

5. Respiratory Virus Detection Products

These kits employ real-time fluorescence quantitative PCR technology. Primers and probes are designed to target specific gene sequences of various respiratory viruses. During PCR amplification, fluorescence signals are monitored in real time, allowing detection of viral infections based on fluorescence signal amplification patterns.

Product Advantages

•Rapid Diagnosis: Enables fast and accurate identification of respiratory viruses during peak respiratory infection seasons, facilitating timely isolation and treatment measures.

•Multi-Virus Detection: Simultaneous detection of multiple common respiratory viruses provides a comprehensive assessment of patient infections and reduces the risk of missed diagnoses.

•Guided Treatment: Identifying the specific viral pathogen helps clinicians select appropriate antiviral therapies and reduce unnecessary antibiotic use.

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