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write down comparative analysis between BD HPV onclarity assay v/s Qiagen careHPV test for cervical cancer....

write down comparative analysis between BD HPV onclarity assay v/s Qiagen careHPV test for cervical cancer. in which includes Explanation and methodology of both test?
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Expert Solution

BD HPV ONCLARITY ASSAY -

The Becton Dickinson (BD) Onclarity HPV Assay is an automated laboratory test used on the BD Viper LT system. This test detects DNA (deoxyribonucleic acid) from 14 high risk human papillomavirus (HPV) types that are associated with cervical cancer. The test specifically identifies HPV types 16, 18 and 45 while concurrently detecting types 31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68.

Human papillomaviruses (HPVs) are a group of over 150 related viruses. Each HPV virus in this large group is given a number which is called its HPV type. Some HPV types can lead to cancer. HPV is transmitted through intimate skin-to-skin contact.

How it works :

Specimens containing cervical cells are collected during a Pap test and loaded onto the Viper LT system. DNA is then separated from those cells, and the device determines the presence or absence of high risk HPV DNA.

Why do we use :

HPV test is done to collect information regarding a woman's risk for cervical cancer. An HPV test is used in conjunction with the physician's assessment and professional guidelines to guide patient management.

What does the test result mean :

Test results can provide the information regarding a woman's risk for developing cervical cancer. A negative test result is useful in ruling out a potentially cancer causing infection. Positive results can guide different follow-up procedures for the patient depending on which HPV type is detected.

HPV negative cancers of the cervix do occur in rare circumstances. Also, no cancer screening test is 100% sensitive.

Note :The use of this test has not been evaluated for women with prior ablative or excisional therapy or who are pregnant.

QIAGEN CARE HPV TEST :

The care HPV Test utilizes the same Hybrid Capture 2 (HC2) technology developed for QIAGEN digene HC2 High-Risk HPV DNA Test (HC2 Test).

The care HPV Test detects the presence of the high-risk carcinogenic HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 using full genome probes complementary to HPV DNA, specific antibodies, signal amplification and chemiluminescent detection. The careHPV Test is used with the careHPV Test system to analyze HPV DNA high risk groups in cervical and vaginal specimens collected with a careBrush and careHPV Collection Medium.

How do we use :

The careHPV Test and careHPV Test System detect the presence of 14 high-risk carcinogenic HPV types using full genome RNA probes complementary to the HPV DNA specific antibodies and chemiluminescent detection. The target DNA combines with specific RNA probes, creating RNA: DNA hybrids. Then, the RNA:DNA hybrids are captured onto a solid phase coated with universal capture antibodies specific for RNA:DNA hybrids. The specimen matrix is washed from the captured hybrids to remove inhibitors.The results are automatically interpreted by the careHPV Test System and are displayed graphically on the careHPV Test Controller screen.

The careHPV Test does not cross-react with microorganisms likely to be found in human cervical or vaginal specimens. The careHPV Test does not cross-react with human genomic DNA. There are no overlapping, cross-reactive DNA sequences in HIV, HBV, EBV, CMV, Adenovirus 2 and Neisseria meningitides.

Substances that may be found in cervical or vaginal specimens were tested for impact on the performance of the careHPV Test. False-positive results were observed with anti-fungal cream but no false positive results were observed with any of the other substances at any concentration tested.

Comparison between BD HPV onclarity assay and QIAGEN CAREHPV TEST : the maximum comparison regarding methodology is covered in the above descriptions.

the BD Onclarity assay is an accurate HPV assay for the detection and genotyping of HR HPV infections.

One interesting point is that, differently from other recently introduced systems, Onclarity is a PCR-based assay in which the target region is within the E6 and E7 regions of the HR HPV genome.


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