HPV

Bosphore HPV Detection Kit v4, is a Real-Time PCR based in-vitro diagnostic medical device, IVD CE marked according to 98/79/EC Directive. Bosphore HPV Detection Kit v4 is a qualitative test used to detect human papilloma virus encompassing the 32 most predominant HPV genotypes found in human biological samples (19 high risk HPV genotypes of 16,18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 73 and 13 low risk HPV genotypes of 6, 7, 11, 13, 40, 43, 44, 62, 72, 74, 81, 83, 89).

Fluorescence detection is accomplished using the FAM filter in two separate tubes, with PCR Master Mix 1 and PCR Master Mix 2 respectively. In the first tube, HPV genotypes 6, 11, 16, 18, 26, 31, 33, 35, 40, 43, 44, 53, 56, 58, 62, 66, 67, 68, 69, 72, 73, 81, 83, 89 are detected and in the second tube, HPV genotypes 6,7, 11, 13, 16,18, 26, 31, 33, 35, 39, 45, 51, 52, 59, 68 are detected. The amplification data of the human papilloma virus (HPV) is detected qualitatively with the SYBR Green filter.

Bosphore HPV Genotyping High Risk Basic Kit v1, 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 Basic Kit v1 detects and characterizes the genotype of human papilloma virus in human biological samples, encompassing the basic high risk group of HPV genotypes; 16, 18 and 31. Fluorescence detection is accomplished using the FAM, HEX, Texas Red and Cy5 filters. The genotypes 16, 18, 31 and internal control are detected with PCR Master Mix including labelled probes in the same well/reaction.

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.

Bosphore HPV Genotyping High Risk Kit v1, 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 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). Fluorescence detection is accomplished using the FAM, HEX, Texas Red and Cy5 filters.

Genotypes 16, 18, 31 and internal control are detected in Detection Mix 1; the genotypes 51, 56, 58 and internal control are detected in Detection Mix 2, the genotypes 33, 35, 52, 59 and internal control are detected in Detection Mix 3 and the genotypes, 39, 45, 66, 68 and internal control are detected in Detection Mix 4 with using labelled probes. The four PCR master mixes function in four 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.

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 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.