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Rapid diagnostic test for hepatitis C approved by WHO

Dec 16, 2016 | Failure to Diagnose

Many people in New York suffer from hepatitis C, and an early diagnosis of the disease may lead to a better patient outcome. In developing countries where medical resources are scarce, diagnosis of hepatitis C can be difficult. A rapid diagnostic test for the disease that was developed in November 2016 may make diagnosis easier, even in places where there is no electricity.

On Dec. 5, the World Health Organization announced that it had prequalified a diagnostic test called SD BIOLINE HCV. The test is the first rapid diagnostic test for hepatitis C that has been approved by WHO. Other tests that have already been on the market were not approved by WHO because they were too expensive or lacked quality. By prequalifying the test, WHO has cleared the way for the test to be used by the United Nations.

The SD BIOLINE HCV test can provide readable results in about five to 20 minutes. The test requires a sample of human serum, plasma or blood to be taken, but extensive training is not needed to perform the test. When WHO announced that it was prequalifying the diagnostic test, WHO said that the test came at an opportune time when developing countries have greater access to effective antiviral drugs.

While rapid diagnostic tests may help many people, these tests may also produce some false positives. If a doctor does not perform follow-up tests to make sure that a patient does have the disease that they tested positive for, the patient could be harmed by a misdiagnosis. People who have been affected by this type of negligent medical treatment may want to discuss their situations with a medical malpractice attorney.