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FDA Donor Testing

Our Tests are FDA Certified for Egg & Sperm Donors

*The FDA requires that all HCT/P donors must be screened for relevant communicable disease agents or diseases (RCDADs) to ensure that the donor is healthy and the patient receives a safe product.​

Our FDA Test Offerings

Stringent screening and testing protocols to safeguard the Health of Recipients

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Female Donor

  1. CT/NG NAT

  2. HBcAb, Total w/ reflex to IgM

  3. HBsAg w/ reflex to HBV DNA Quant

  4. HCV Ab w/ rfx to HCV RNA Quant

  5. HIV-1/HCV/HBV Ultrio NAT 

  6. HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant

  7. T. pallidum, IgG (Syphilis) 

  8. West Nile Virus, RNA 

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Male Donor

  1. CMV, Total w/ reflex to IgM/IgG

  2. CT/NG NAT

  3. HBcAb, Total w/ reflex to IgM

  4. HBsAg w/ reflex to HBV DNA Quant

  5. HCV Ab w/ rfx to HCV RNA Quant

  6. HIV-1/HCV/HBV Ultrio NAT 

  7. HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant

  8. HTLV I/II Ab

  9. T. pallidum, IgG (Syphilis) 

  10. West Nile Virus, RNA 

Pink Petals

Download our FDA Binder

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CMV, Total w/ reflex to IgM/IgG: This test checks for the presence of Cytomegalovirus (CMV), a common virus that can cause symptoms like a fever or sore throat. If the test is positive, it'll automatically be followed by two more tests (IgM and IgG) to figure out if the infection is new or old.

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CT/NG NAT: This is a test for two sexually transmitted infections: chlamydia (CT) and gonorrhea (NG). The NAT part means it looks for the actual genetic material of the bacteria.

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HBcAb, Total w/ reflex to IgM: This checks for antibodies to the hepatitis B virus. If positive, an additional test (IgM) will be done to see if the infection is recent.

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HBsAg w/ reflex to HBV DNA Quant: This test looks for a specific protein that's present if you have a hepatitis B infection. If positive, another test will be done to measure the amount of hepatitis B virus DNA in your blood.

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HCV Ab w/ rfx to HCV RNA Quant: This test looks for antibodies to the hepatitis C virus. If positive, it'll be followed by another test that measures the amount of the virus's genetic material (RNA) in your blood.

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HIV-1/HCV/HBV Ultrio NAT: This test checks for three viral infections: HIV-1, hepatitis C (HCV), and hepatitis B (HBV). Like the CT/NG NAT test, this one also checks for the actual genetic material of the viruses.

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HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant: This test checks for HIV infection. If positive, an additional test is done to measure the amount of HIV in the blood.

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HTLV I/II Ab: This test checks for infection with Human T-cell Lymphotropic Virus types I and II, which can cause certain types of cancer and neurological disease.

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T. pallidum, IgG (Syphilis): This is a test for syphilis, a sexually transmitted infection. It's looking for IgG antibodies that are made by your body to fight the bacteria.

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West Nile Virus, RNA: This test checks for the West Nile Virus by looking for its genetic material in your blood. This virus is often spread by mosquito bites.

Our Mission for Accessibility

Commitment to Quality and Patient Care

IHDLab is committed to making fertility services more affordable and accessible by offering cost-effective solutions, comprehensive support, and collaborating with various organizations and advocacy groups. We are also continuously investing in research and technology to streamline processes and reduce costs.

Why use IHDLab for you FDA Testing?

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  • Leverage our all-inclusive in-house donor testing portfolio, accessible five days a week.

  • Highly skilled quality assurance team is backed by years of experience and dedicated to ensuring precision in every result.

  • Devoted customer service personnel, along with readily available technical consultation, support seamless client interactions.

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​To learn more about Donor Eligibility please see the FDA Guidelines.​

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