HPV

Bosphore HPV Genotyping High Risk Kit v1 detects and characterizes the genotype of Human Papilloma Virus in human biological samples, encompassing high risk group of HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The analytic sensitivity is 1×103 IU/ml (1×103 GEq/ml). Fluorescence detection is accomplished using the FAM, HEX, Texas RED and Cy5 filters. The genotypes 16, 18, 31 and internal control are detected in PCR Master Mix 1; the genotypes 51, 56, 58 and internal control are detected in PCR Master Mix 2, the genotypes 45, 35, 59 and internal control are detected in PCR Master Mix 3, the genotypes, 39, 66, 68 and internal control are detected in PCR Master Mix 4 and the genotypes 33, 52 and internal control are detected in PCR Master Mix 5 with using labeled probes. The five PCR master mixes function in five separate wells/reactions.

Two internal controls have been integrated into the kit in order to check PCR inhibition, DNA extraction and application errors. Internal Control EXT is used in DNA extraction and Internal Control PCR is used in PCR step. Amplification data of the internal control is detected with the Cy5 filter.

Bosphore HPV Genotyping High Risk Kit v4 (Fast Extraction) is a Real-Time PCR based in-vitro diagnostic medical device, IVD CE marked according to 98/79/EC Directive. Bosphore HPV Genotyping High Risk Kit v4 detects and characterizes the genotype of human papilloma virus in human biological samples, encompassing high risk group of HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). Fluorescence detection is accomplished using the FAM, HEX, Texas RED and Cy5 filters.

The genotypes 16, 18, 31 and internal control are detected in PCR Master Mix 1;

The genotypes 51, 56, 58 and internal control are detected in PCR Master Mix 2,

The genotypes 45, 35, 59 and internal control are detected in PCR Master Mix 3,

The genotypes, 39, 66, 68 and internal control are detected in PCR Master Mix 4 and

The genotypes 33, 52 and internal control are detected in PCR Master Mix 5 with using labelled probes. The five PCR master mixes function in five separate wells/reactions.

An internal control has been integrated into the kit in order to check PCR inhibition. The amplification data of the internal control is detected with the Cy5 filter. The internal control is added into the sample at the PCR step. Only a single incubation with the EX-Tract DNA solution is enough to prepare the samples for qPCR. There is no need to apply an external DNA isolation.

Bosphore HPV HR-LR Genotyping Kit v1 detects and characterizes the genotype of human papilloma virus in human biological samples (swab, tissues, biopsy specimen, serum, plasma), encompassing high risk (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and low risk (6, 11, 42, 61, 70) groups of HPV genotypes. Fluorescence detection is accomplished using the FAM, HEX, Texas Red and Cy5 filters.

The genotypes 16, 18, 31 and internal control are detected in PCR Master Mix 1; the genotypes 51, 56, 58 and internal control are detected in PCR Master Mix 2, the genotypes 35, 45, 59 and internal control are detected in PCR Master Mix 3, the genotypes, 39, 66, 68 and internal control are detected in PCR Master Mix 4 and the genotypes 33, 52 and internal control are detected in PCR Master Mix 5, the genotypes 6, 11, 42 and internal control are detected in PCR Master Mix 6, the genotypes 61, 70 and internal control are detected in PCR Master Mix 7 with using labeled probes. Seven PCR master mixes are used in seven separate wells/reactions.

An internal control has been integrated into the kit in order to check DNA extraction and PCR inhibition. The amplification data of the internal control is detected with the Cy5 filter. The internal control can be added either during DNA extraction or PCR step.

Bosphore HPV Genotyping Kit HR-LR v2 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes the genotype of human papilloma virus in human biological samples (swab, tissues, biopsy specimen, serum, plasma), encompassing high risk (16, 18, 31) and low risk (6, 11, 42) groups of HPV genotypes. Fluorescence detection is performed using FAM, HEX, Texas RED, and Cy5 filters.

Two internal controls have been integrated into the kit in order to check PCR inhibition, DNA extraction and application errors.  Internal control EXT is used in DNA extraction and Internal control PCR is used in PCR step. Amplification data of the internal control is detected with the Cy5 filter. The internal control can be added either during DNA extraction or the PCR step.

Bosphore HPV HR-LR-Genotyping Kit v3 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes the genotype of Human Papilloma Virus encompassing high risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 73*, 82) and low risk (6, 11, 40, 42, 43, 44, 54, 61, 70) groups of HPV genotypes. This kit is designed to work with a variety of sample types for comprehensive HPV detection and genotyping. It is compatible with cervical, semen samples, genital swabs from both females and males, as well as tissue biopsies and samples from warts. Fluorescence detection is performed using FAM, HEX, Texas RED, and Cy5 filters.  

*HPV 73 is classified as either an intermediate-risk or probably a high-risk genotype.  

An exogenous internal control has been integrated into the kit to check DNA extraction, PCR inhibition, or application problems. The amplification data of the exogenous internal control is detected with the Cy5 filter of PCR Master Mix 4 and PCR Master Mix 7. Internal Control EXT is used in DNA extraction and Internal Control PCR is used in the PCR step.  

An endogenous internal control based on the detection with the Cy5 filter of human endogenous nucleic acid sequence (GAPDH gene) present in the human genome has been employed in order to check DNA extraction, sampling, or application problems. The amplification data of the endogenous internal control is detected with the Cy5 filter in PCR Master Mix 1.  

Bosphore HPV HR-LR-Genotyping Kit v4 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes the genotype of Human Papilloma Virus encompassing high risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 82) and low risk (6, 11, 42) groups of HPV genotypes. This kit is designed to work with a variety of sample types for comprehensive HPV detection and genotyping. It is compatible with cervical swabs (liquid-based cytology samples including those collected using ThinPrep (Hologic) and SurePath (Becton Dickinson), semen samples, genital swabs from both females and males, as well as tissue biopsies and samples from warts. Fluorescence detection is performed using the FAM, HEX, Texas RED and Cy5 filters.

An exogenous internal control has been integrated into the kit to check DNA extraction, PCR inhibition, or application problems. The amplification data of the exogenous internal control is detected with the Cy5 filter of PCR Master Mix 4 and PCR Master Mix 6.

Internal Control EXT is used in DNA extraction and Internal Control PCR is used in PCR step.

An endogenous internal control based on the detection with the Cy5 filter of human endogenous nucleic acid sequence (GAPDH gene) present in human genome has been employed in order to check DNA extraction, sampling or application problems. The amplification data of the endogenous internal control is detected with the Cy5 filter in PCR Master Mix 1.

Bosphore HPV Screening Kit v1 detects human papillomavirus encompassing the 15 HPV high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) in human biological samples.  Fluorescence detection is accomplished using the FAM, HEX and TEXAS RED filters.

An internal control based on the detection of human endogenous nucleic acid sequence present in the human genome has been integrated into the PCR Mix to check nucleic acid extraction, PCR inhibition and sampling or application errors. The amplification data of the internal control is detected with the Cy5 filter.

Bosphore HPV Screening Kit v2 detects Human Papilloma Virus encompassing the 15 HPV high risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) and 17 HPV low risk and other genotypes (6, 7, 11, 13, 34, 40, 42, 43, 44, 55, 61, 62, 70, 73, 74, 81, 91) found in human biological samples.  Regions within the L1, E1, E2, E6, and E7 genes are amplified, and fluorescence detection is accomplished using the FAM, HEX, Texas Red, and Cy5 filters.

An internal control based on detecting human endogenous nucleic acid sequence in the human genome (GAPDH) has been integrated into the PCR Mix 1 to check nucleic acid extraction, PCR inhibition, and sampling or application errors.

Bosphore HPV Screening Kit v4 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes 15 HPV high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) of E6 and E7 genes. This kit is designed to work with a variety of sample types for comprehensive HPV detection and genotyping. It is compatible with cervical swabs (liquid-based cytology samples, including those collected using ThinPrep (Hologic) and SurePath (Becton Dickinson)), semen samples, genital swabs from both females and males, as well as tissue biopsies and samples from warts.

Fluorescence detection is performed using FAM, HEX, Texas RED, Cy5, and Quasar 705 filters. HPV 16 DNA is amplified, and fluorescence detection is performed using the FAM filter. HPV 18 DNA is amplified, and fluorescence detection is performed using the HEX filter; other high-risk HPV genotypes are amplified, and fluorescence detection is performed using the Texas RED filter; HPV 45 DNA is amplified, and fluorescence detection is performed using the Quasar 705 filter.

An endogenous internal control based on the detection with the Cy5 filter of human endogenous nucleic acid sequence (GAPDH) present in the human genome has been employed to check sampling, extraction, PCR inhibition, and application errors. The endogenous internal control amplification data is detected with the Cy5 filter in PCR Master Mix.

This version of the kit is fully compatible with UNIO 448 System, which performs automated magnetic bead–based nucleic acid extraction, PCR setup, amplification, and fluorescence detection in a closed and contamination-controlled environment.

UNIO 448 software automatically recognizes barcoded reagents and applies the validated assay protocol for Bosphore HPV Screening Kit v4. Before starting the run, the QR code located on the PCR kit must be scanned by the barcode reader of the UNIO 448 System.

Bosphore HPV Screening Kit v5 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes 15 HPV high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 67, 68) of E6, E7, and L1 genes. This kit is designed to work with a variety of sample types for comprehensive HPV detection and genotyping. It is compatible with cervical swabs (liquid-based cytology samples, including those collected using ThinPrep (Hologic) and SurePath (Becton Dickinson)), semen samples, genital swabs from both females and males, as well as tissue biopsies and samples from warts. Fluorescence detection is performed using FAM, HEX, Texas RED, and Cy5 filters. HPV 16 DNA is amplified, and fluorescence detection is performed using the FAM filter, HPV 18/HPV 45 DNAs are amplified, and fluorescence detection is performed using the HEX filter, and other high-risk HPV genotypes are amplified, and fluorescence detection is performed using the Texas RED filter.

An endogenous internal control based on the detection with the Cy5 filter of human endogenous nucleic acid sequence (GAPDH) present in the human genome has been employed to check sampling, extraction, PCR inhibition, and application errors. The endogenous internal control amplification data is detected with the Cy5 filter in PCR Master Mix.

Bosphore HPV Screening Kit v7 is a Real-Time PCR kit for in vitro diagnostics that detects and characterizes the 16 HPV high/possible high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68) of E6, E7, and L1 genes. This kit is designed to work with a variety of sample types for comprehensive HPV detection and genotyping. It is compatible with cervical swabs (liquid-based cytology samples, including those collected using ThinPrep (Hologic) and SurePath (Becton Dickinson)), semen samples, genital swabs from both females and males, as well as tissue biopsies and samples from warts.

For PCR Master Mix 1, fluorescence detection is performed using FAM, HEX, Texas RED, and Cy5 filters. HPV 16 DNA is amplified and fluorescence detection is performed using the FAM filter, HPV 18 DNA is amplified and fluorescence detection is performed using the HEX filter, and other high risk HPV genotypes (31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 67, 68) are amplified and fluorescence detection is performed using the Texas RED filter.

For PCR Master Mix 2, fluorescence detection is performed using FAM, HEX, and Cy5 filters. HPV 45 DNA is amplified, and fluorescence detection is performed using the FAM filter; HPV 53 DNA is amplified, and fluorescence detection is performed using the HEX filter.

An endogenous internal control targeting the human endogenous nucleic acid sequence (GAPDH), detected using the Cy5 filter in PCR Master Mix 1, has been employed to monitor sampling, extraction, PCR inhibition, and application errors.

Exogenous internal control has been integrated into the kit to check DNA extraction, PCR inhibition, or application problems. The amplification data of the exogenous internal control is detected with the Cy5 filter of PCR Master Mix 2. Internal Control EXT is used in DNA extraction, and Internal Control PCR is used in the PCR step.