Launch of the first FDA-approved technology in Iran to diagnose HPV (updated)

Launch of the first FDA-approved technology in Iran to diagnose HPV (updated)


Nilou Laboratory hereby announces the launch of Cobas HPV DNA Testing technology as the first FDA (FDA approved) technology in Iran to detect HPV in vaginal and cervical secretions.

Notes

- Cervical cancer is the second leading cause of death from cancer in women.

In 2006, about 500,000 new cases of cervical cancer were reported, of which about 280,000 died.

Most of these patients live in developing countries, such as Africa, Central America, and South America.

- According to the Cancer Institute's report on cancer registration, the prevalence of uterine and cervical cancer is about 6-7%.

- This cancer generally occurs between the ages of 30 and 55, but recently there have been several reports of it in young women.

Since 2000, the HPV virus has been identified as an etiological cause of cervical cancer, and cervical cancer is the only solid cancer with a specific cause of viral infection in women.

The virus is involved in 30% of oropharyngeal cancers, 45 to 95% of anal cancers, 60 to 65% of vaginal cancers and 40 to 60% of Volvo cancers.

- This technology is based on the latest ASCCP guideline (American Society for Colposcopy and Cervical Pathology), for clinical use of HPV testing with Pap smear or double-co-testing (Co-testing) to track abnormal cytological results.

- Based on this guideline, follow-up based on HPV results will lead to the desired result when reliable methods are used to test HPV. that's mean

- Methods that are analytically and clinically valid and reproducibility, clinical sensitivity, positive and negative predictive properties and value to prove the existence of CIN 2+ based on the document provided by the FDA Proven and approved.

Based on this guideline, vaginal discharge genotypes that cause genital warts and its diagnosis does not change the treatment strategy of warts should be avoided in the case of vaginal discharge (due to the possibility of over-treatment or overtreatment).

- This technology is performed fully automatically from the DNA extraction stage to the final interpretation and report.

- This technology prevents many errors between laboratories that exist in methods without FDA approval. These errors can severely affect the strategies for tracking abnormal results and lead to misleading actions.

- Combining a Pap smear test with an FDA-approved HPV test can increase the sensitivity of cervical cancer detection by 87 to 100%.

- The results of this test are reported in four modes: Negative, Positive for HPV 16, Positive for HPV 18 and Positive for other hr HPV.

- The answer is given within 4 working days after the patients come to the laboratory.

- In case of sending a sample of partner laboratories, the answer must be attached to the laboratory report with the letterhead of Nilo Laboratory, and otherwise Nilo Laboratory has no obligation to verify the test in the above method.