Who is FidaLab? 
 
FidaLab is a privately owned diagnostic laboratory based in Seattle Washington. Specializing in DNA-based molecular testing that is both accurate and timely, our mission is to empower people to take control of their health. With a name inspired by the Latin word for faithfulness, loyalty, and trust, we strive to build trust with healthcare providers and at-risk individuals alike. Utilizing cutting-edge technologies, we are committed to improving lives by assisting with early detection, prevention, and intervention for various diseases. 

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Fidalab is CLIA certified, meaning that our laboratory complies with the Clinical Laboratory Improvement Amendments (CLIA) regulations. These regulations, enforced by the Centers for Medicare & Medicaid Services (CMS), establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA certification demonstrates that Fidalab meets these rigorous standards and is dedicated to providing the highest quality testing services to our clients. 

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Why should I get tested? 

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At-home testing offers several benefits that can help you take control of your health and make informed decisions, including: 

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• Early detection: Many STIs can be asymptomatic or have mild symptoms that are easily overlooked. Early detection through testing can help prevent complications and reduce the risk of transmission to others. 

• Peace of mind: Knowing your STI status can provide peace of mind, especially if you're sexually active or have multiple partners. 

• Timely treatment: Prompt diagnosis and treatment of STIs can help prevent long-term health problems, such as infertility, chronic pain, or increased risk for certain types of cancer. 

• Protecting your partner(s): Regular STI testing can help you protect your sexual partner(s) from potential infections and maintain a healthy relationship. 

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How do the tests work? 

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Our At-Home tests utilize q-PCR (quantitative Polymerase Chain Reaction) methods, a form of NAAT (Nucleic Acid Amplification Test) to detect organisms, such as bacteria or viruses, associated with specific conditions like STIs and UTIs. This process involves extraction of nucleic acid from samples, followed by amplification of specific nucleic acid sequences that are unique to the target organism. This highly sensitive technique allows for accurate detection and identification of even small amounts of the target organism's genetic material. Once the analysis is complete, you'll receive a detailed report outlining the test results, which can help you and your healthcare provider make informed decisions about your health and treatment options. 

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How accurate are the tests? 

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q-PCR testing is considered one of the most accurate diagnostic methods for detecting and quantifying specific genetic material from organisms, such as bacteria or viruses. q-PCR testing has a high sensitivity and specificity, which means it can accurately identify the presence or absence of the target organism with a low rate of false-positive or false-negative results. Sensitivity and specificity rates for q-PCR tests can vary depending on the specific test and organism but typically range from 95% to 99% or higher. 

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However, it's important to note that the accuracy of q-PCR testing can be influenced by various factors, such as the timing of sample collection, proper sample handling, and the presence of inhibitors that might interfere with the test's performance. To achieve the best possible results, it's crucial to follow the sample collection and handling instructions provided with your at-home test kit. 

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How easy is it to collect a sample? 

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Using our At-Home STD and UTI kits is extremely easy! Each kit includes a pop-out silicone cup for convenient urine collection, as well as a pipette to transfer the specimen into an industry-standard specimen transport tube. The tube is designed with a stabilizing agent to maintain the sample's integrity during shipping, ensuring accurate and reliable test results. 

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Do I need to register my kit? 

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Kit registration is required for sample processing. To register your kit, please use the button on our homepage or visit secure.athome.fidalabus.com/register before sending your at-home kit back to us. Unregistered kits that arrive at the lab will not be processed until the registration process is completed. 

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Do you offer discreet shipping? 

 

All FidaLab At-Home test kits are delivered in discreet, unmarked plastic mailer paks. A similarly plain mailer is also included for returning your sample, ensuring privacy throughout the entire process. 

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What is the shipping process? 

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Kits are sent to you using FedEx Express, typically arriving within 1-2 days. For return shipping, we provide a prepaid USPS Priority Mail label. To return your sample, you can either schedule a pickup on the USPS website, leave the package in your mailbox, or drop it off at your nearest USPS drop-off location. Priority Mail delivery times vary from 1-3 days, depending on your distance from our lab in Seattle. The kit price includes shipping costs for both delivery to you and return to our lab, with no additional fees. For a full breakdown, see our Shipping Policy. 

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How long does it take to get my results? 

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Once the sample arrives at our lab, results will be processed and available within 1-2 days. However, please be aware that delays may occur due to unforeseen circumstances. If any issues arise while processing your sample, we will promptly reach out to you. 

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How private are my results? 

 

At FidaLab, we prioritize the privacy of our clients' personal data. We maintain strict confidentiality and do not disclose or sell your information to any third party under any circumstances. As a certified lab under the Clinical Laboratory Improvement Amendments (CLIA), we adhere to stringent privacy guidelines and comply with the regulations of the Health Insurance Portability and Accountability Act (HIPAA) with regard to Protected Health Information (PHI). For detailed information, please see our official Privacy Policy. 

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What do I do if I test positive? 

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Positive results will be reviewed by our in-house physician, who will provide recommended treatment notes. However, as a clinical laboratory, we cannot prescribe treatment. We advise taking our lab-certified results to your healthcare provider for further guidance. In the meantime, there's no need to panic, as most STIs can be easily managed or cured with appropriate treatment. However, it's best to refrain from sexual activity until speaking with a healthcare professional. 

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Does a negative result mean I don’t have a STI? 

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A negative result indicates that no specific nucleic acid sequences associated with organisms that cause the listed STIs were found in your specimen. However, STIs can have varying incubation periods, and you may test negative if it has been too close to your last possible exposure, and the present amount of organisms are below the detection limit. This is why regular testing is crucial for an accurate assessment of your health status. For more information about STI incubation periods, see this Center for Disease Control (CDC) information page.

 

Why should I choose your at-home test instead of going directly to a clinic or my healthcare provider? 

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Our at-home test offers discretion and convenience, eliminating the need for appointments, phone calls, or in-person visits. Additionally, most healthcare providers require sample collection at their facility and then wait for their lab results before prescribing treatment, which can take longer than our test due to reliance on large national laboratories. By using our at-home kit, you can decide to see your provider only if you test positive, bringing our lab-certified results for immediate treatment. This approach can potentially reduce insurance and co-pay costs by decreasing the number of provider visits and avoiding insurance-inflated lab testing fees. 

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Do you accept insurance? 

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At present, FidaLab At-Home kits are only available for purchase without insurance. We may consider accepting insurance in the future, but for now, we have made this decision based on several factors: 

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• Medical Necessity: Insurance companies often require proof of medical necessity for test coverage, meaning that a current physician's order would be needed for testing. 

• Privacy: If we were to bill insurance, we would need to report your test results to your insurance company, which would then become part of your medical record. 

• Pricing: Insurance billing involves additional processing time and complex billing practices. By not accepting insurance, we can maintain lower kit prices compared to conventional testing methods offered by other national laboratories. 

 

We understand that some individuals may require financial assistance in covering the costs of testing, and we are exploring options to make this possible while balancing the trade-offs involved. We will keep you updated on any future developments regarding insurance coverage.

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