Sars-CoV-2
Diagnovital Sars-CoV-2 Real Time PCR Kit
DIAGNOVITAL® SARS-CoV-2 is a real-time RT-PCR-based detection system for the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is considered a novel human coronavirus that is genetically distinct from the common human coronaviruses (229E, NL63, OC43, HKU1), which cause seasonal acute respiratory illness. It is also genetically distinct from the two newer human coronaviruses, MERS-CoV and SARS-CoV.
DIAGNOVITAL® SARS-CoV-2 detects the presence of 2 different and highly specific gene sequences of SARS-CoV-2: E gene and RdRp gene. All 2 essays must be tested positive to confirm the sample as SARS-CoV-2-positive.
Additionally, a non-infectious positive control and a negative human extraction control are included. Human Extraction Control (HEC) is needed to ensure appropriate RNA extraction, purification, and reverse transcription and all reagents involved in the reaction. The Human Extraction Control (HEC) master mix contains primers and probes for an endogenous human target, which is extracted from the swab during the extraction step. We don’t put an external DNA or RNA template as extraction control, since we already get a human target during extraction. The positive control is used to confirm the functionality of the assays and overall PCR performance, the negative human extraction control is included to evaluate the quality of the RNA isolation independently from the SARS-CoV-2 assays.
Diagnovital Sars-Cov-2 Multiplex Real Time PCR Kit
Diagnovital SARS-CoV-2 Multiplex is a real-time RT-PCR-based detection system for the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is considered a novel human coronavirus that is genetically distinct from the common human coronaviruses (229E, NL63, OC43, HKU1), which cause seasonal acute respiratory illness. It is also genetically distinct from the two newer human coronaviruses, MERS-CoV and SARS-CoV.
Diagnovital SARS-CoV-2 Multiplex detects the presence of 2 different and highly specific gene sequences of coronaviruses (N1 and N2) at the FAM channel and one sequence-specific for human RNA serving as a human extraction control (HEC, RNaseP) at the HEX/VIC channel. All 2 assays must be tested positive to confirm the sample as SARS-CoV-2-positive.
Additionally, a non-infectious positive control and a negative human extraction control are included. Human Extraction Control (HEC) is needed to ensure appropriate RNA extraction, purification, and reverse transcription and all reagents involved in the reaction. The Human Extraction Control (HEC) master mix contains primers and probes for an endogenous human target, which is extracted from the swab during the extraction step. We don’t put an external DNA or RNA template as extraction control, since we already get a human target during extraction. The positive control is used to confirm the functionality of the assays and overall PCR performance, the negative human extraction control is included to evaluate the quality of the RNA isolation independently from the SARS-CoV-2 assays.
Diagnovital Sars-Cov-2 HS Real Time PCR Kit
Diagnovital HS SARS-CoV-2 is a qualitative test for the detection of the 2019 novel coronavirus (SARS-CoV-2) in upper respiratory swab samples collected in Copan Universal Transport Medium System (UTM-RT) or BD Universal Viral Transport System (UVT) and is run on Applied Biosystems QuantStudio 5 in combination with Tianlong Generotex 96 extraction system and Tianlong Viral DNA/RNA Extraction Kit. In addition, the test utilizes external controls (positive control and negative control).
Diagnovital HS SARS-CoV-2 test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection. The test is run on Applied Biosystems QS5. Nucleic acid from patient samples and controls is extracted using the Tianlong Generotex 96 extraction system and Tianlong Viral DNA/RNA Extraction Kit. Nucleic acid is released by the lysis reagent and bound to magnetic beads. Unbound substances and impurities, such as denatured protein, cellular debris, and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted in the elution buffer.
selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers and probes specific to conserved regions of the N1 and N2 genes for SARS-CoV-2.
selective amplification of RNA Internal Control is achieved by the use of non-competitive, sequence-specific forward and reverse primers and a probe that has no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.
Other Infectious Diseases
HBV Real-Time PCR Kit
A1 HBV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantification of Hepatitis B Virus DNA in human serum or plasma. The kit is designed to be used as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory findings.
A1 HBV Real-Time PCR Kit has been validated for use with A1 Viral DNA Isolation Kit or A1 Viral Nucleic Acid Isolation Kit for its best performance.
A1 Real-Time PCR Kits are certified and marked with CE-IVD to meet specific quality and purity requirements in the diagnostic market.
HCV Real-Time PCR Kit
A1 HCV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for quantification of Hepatitis C virus (HCV) RNA in human serum or plasma (EDTA). HCV Real-Time PCR Kit has been validated for use with A1 Viral RNA Isolation Kit or A1 Viral Nucleic Acid Isolation for sample preparation and below listed instruments for amplification. All necessary reagents optimized for reliable HCV RNA detection and quantification.
A1 Real-Time PCR Kits are certified and marked with CE-IVD to meet specific quality and product safety requirements in the diagnostic market.
HIV-1 Real-Time PCR Kit
A1 HIV-1 Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantification of Human Immunodeficiency Virus RNA in human serum or plasma samples. This diagnostic test kit utilizes the reverse transcription-polymerase chain reaction (RT-PCR).
A1 HIV-1 Real-Time PCR Kit has been validated with A1 Viral Nucleic Acid Isolation Kit for use with below-listed instruments for amplification.
A1 Real-Time PCR Kits are certified and marked with CE-IVD to meet specific quality and product safety requirements in the diagnostic market.
HCV Genotyping qPCR Kit
A1 HCV Genotyping qPCR Kit is an in vitro nucleic acid amplification assay for the identification of the genotypes of Hepatitis C virus (HCV) RNA in human serum or plasma (EDTA). A1 HCV Genotyping real-time Kit detects HCV genotypes 1a, 1b, 2, 3, 4, 5, and 6. A1 HCV Genotyping qPCR Kit is intended for use as an aid in the management of patients with chronic HCV infection and creating a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings.A1 HCV Genotyping qPCR Kit provides you everything needed for a reliable and efficient identification:
- The very high sensitivity of identification of HCV genotypes in 4 different tubes.
- Highly precise discrimination of 1a vs. 1b subtypes.
- Highly compatible results with sequencing (> 99 %).
- The whole process check by adding the internal control during extraction.
Nucleic acid extraction is a decisive step prior to real-time since; providing high yields of nucleic acid and removal of PCR inhibitors, in turn, improve the amplification efficiency and critical for avoiding false-negative PCR results.
A1 HCV Genotyping qPCR PCR Kit has been validated for use with A1 Viral RNA Isolation Kit or A1 Viral Nucleic Acid Isolation Kit for its best performance.