The PlusLife COVID-19 test is a high-accuracy, at-home molecular testing device designed to provide rapid results comparable to laboratory-based polymerase chain reaction (PCR) tests. Unlike many widely available rapid tests that detect viral proteins, the PlusLife system detects the virus’s genetic material, offering a level of precision generally associated with clinical settings. This device informs users of their current infection status, enabling timely decisions regarding isolation and care.
How the Molecular Test Works
The PlusLife test operates as a nucleic acid rapid test, looking for the genetic signature of the SARS-CoV-2 virus rather than its surface proteins. This system utilizes a proprietary thermostatic amplification technique called RNase Hybridization-Assisted Amplification (RHAM). RHAM is a form of isothermal amplification, which works similarly to PCR but without the complex, rapid temperature cycling required by laboratory equipment.
Once the sample is loaded, RHAM technology quickly and exponentially multiplies the target viral RNA sequences if they are present. The test specifically looks for the N gene and the ORF1ab gene of SARS-CoV-2. This amplification makes even very small amounts of the virus detectable, making molecular tests more sensitive than traditional antigen tests. The process occurs within a small, portable Mini Dock device, providing a lab-quality result faster than standard PCR.
Preparing and Running the Test
The testing process begins with the collection of an anterior nasal swab sample. Gently insert the swab approximately 1.5 to 2 centimeters into one nostril, pressing it against the inner nasal wall and rotating five times for about 10 seconds. Repeat this process in the second nostril using the same swab. Perform the test at room temperature and avoid getting mucus on the swab.
After collection, place the swab into the tube containing the nucleic acid releasing agent, where it is rotated and squeezed multiple times to mix the sample with the liquid. Transfer the liquid into the reaction card until it rests between the two marked level lines. Once the cap is screwed onto the card, wait about 15 seconds for the liquid to settle before pressing the button on the cap, which helps fill the reaction chambers and prevents air bubbles.
Insert the reaction card into the Mini Dock device and close the lid to begin the test run. The test can be started either by pressing the button on the device or through a connected application. The total time required from sample preparation to receiving the result is typically between 10 and 38 minutes. Starting the test immediately after the card is inserted is important for maintaining accuracy.
Clinical Performance Metrics
The accuracy of the PlusLife test is measured using standard clinical performance metrics, primarily comparing its results to the gold-standard laboratory RT-qPCR test. In clinical studies, the test demonstrated very high reliability when samples were tested immediately. The test’s overall sensitivity, its ability to correctly identify positive cases, was approximately 98.3%. Specificity, its ability to correctly identify negative cases, was about 99.3%.
The test’s limit of detection (LOD), the minimum concentration of virus it can detect, is specified at 400 copies/mL, a level comparable to laboratory PCR tests. In one comparative study, the PlusLife Mini Dock demonstrated a Positive Percent Agreement (PPA) of 99.00% and a Negative Percent Agreement (NPA) of 100.00% against RT-PCR confirmed samples. This performance is comparable to other molecular point-of-care devices reviewed.
While the test has received various international approvals, consumers should be aware that the PlusLife SARS-CoV-2 Card has been subject to a Class 2 Device Recall in the United States due to distribution without required FDA premarket authorization.
Understanding Your Results and Next Steps
The result of the PlusLife test is displayed on the Mini Dock device or through an accompanying application. The device provides a simple binary result, indicating either “Positive” or “Negative.” If the device fails to detect the internal control (a human housekeeping gene sequence), the result will be reported as “Invalid,” suggesting a problem with sample collection or the test process.
A positive result means that the SARS-CoV-2 genetic material was detected in the sample, indicating an active infection. Following a positive test, public health guidance generally advises the individual to begin isolation immediately to prevent further transmission. A negative result means the virus was not detected above the test’s limit of detection, but retesting may be recommended if symptoms are present or exposure is recent.
If the result is invalid, the test should be repeated entirely with a new sample and a new test card. Regardless of the result, individuals should follow local health authority guidelines and may consider reporting their results to a healthcare provider or public health authorities as required in their region.