A Medical Device Daily
New Jersey Gov. Richard Codey has signed legislation requiring healthcare providers to test pregnant women for HIV as part of routine prenatal care. The bill also requires testing of newborns whose mother’s HIV status is either positive or unknown at the time of delivery.
According to the Kaiser Foundation, New Jersey is the first state to push HIV testing for both pregnant women and newborns.
“Since the early 1990s, we’ve made great strides in reducing the HIV transmission rate to newborns. But even one infected baby is one too many,” said Codey. “Today, New Jersey becomes the first state to require universal opt-out HIV testing for pregnant women, a move that has the potential to dramatically reduce the transmission of HIV from a pregnant mother to her newborn.”
Codey sponsored the bill as the Senate president. He was acting governor while Gov. Jon Corzine was out of the country for the holidays.
The Centers for Disease Control and Prevention (Atlanta) estimates that perinatal transmission rates can be reduced to less than 2% with universal screening of pregnant women in combination with prophylactic administration of antiretroviral drugs, a Cesarean delivery and avoidance of breast feeding.
The legislation requires that all pregnant women be tested for HIV as early as possible in their pregnancy and again during their third trimester. In addition, each birthing facility in the state is now required to test any newborn whose mother’s HIV status is either positive or unknown at the time of delivery.
“Early detection is the key to helping people living with HIV/AIDS to live longer with a better quality of life. Currently we have the treatment available to help prevent the transmission of HIV from mothers to their babies,” said Sen. Loretta Weinberg (D–Bergen), a primary sponsor of the bill. “This measure is a huge step forward in terms of protecting all babies while helping to educate mothers.”
The measure moves New Jersey from “opt in” status to “opt out” status, meaning women will automatically be tested unless they choose not to be. Physicians and healthcare practitioners now are required to provide women with information about HIV and AIDS, the benefits of being tested, the medical treatment available to treat HIV infection, and the reduced rate of transmission to a fetus if an HIV-infected pregnant woman receives treatment.
Arkansas, Michigan, Tennessee and Texas require health care providers to test a mother for HIV, unless the mother asks not to be tested, while Connecticut, Illinois and New York test all newborns for HIV.
The Commissioner of the Department of Health and Senior Services is responsible for adopting regulations to carry out the testing requirements, as well as guidelines for the information that physicians must provide their patients on testing, treatment and counseling.
In 2005, a task force of the Agency for Healthcare Research and Quality (Rockville, Maryland) issued a recommendation suggesting that all pregnant women – not just those identified as at risk for contracting HIV – be screened for the infectious disease. (Medical Device Daily, July 6, 2005).
Some of the companies that produce HIV tests include:
• Calypte Biomedical (Lake Oswego, Oregon), which markets Aware HIV-1/2 OMT oral fluid rapid test.
• OraSure Technologies (Bethlehem, Pennsylvania), which makes the OraQuick Advance Rapid HIV-1/2 Antibody Test.
• Laboratory Corporation of America Holdings (Burlington, North Carolina), which has introduced an enhanced HIV Screening Assay to identify individuals with primary HIV infection.
A Canadian provider of rapid HIV testing in the U.S. has previously supported this type of recommendation.
Giles Crouch, VP of global sales and marketing for MedMira (Halifax, Nova Scotia), which makes the MiraWell Rapid HIV Test, said, “The CDC gives one direction that’s very useful, but you need more than one [recommendation]. It’s sort of a second seal of approval for healthcare providers. Rapid testing in maternity settings is still quite new, and now the tests that are out there are proven reliable.” (MDD, July 6, 2005).