12/2/2023 0 Comments Colossal cave picturesIf you’ve never played the Colossal Cave Adventure and you’re curious what it was like, here’s a simulation sponsored by the AMC-TV show Halt and Catch Fire. It spawned a long line of imitations that continues to this day, though you might not recognize most of its descendants based on the text screen reproduced above. The Colossal Cave Adventure looks deceptively simple - you type in one- or two-word commands to move around in and interact with a world described purely through text - yet it created a remarkably large, surprisingly open world and went on to become one of the most influential computer games ever written. Here’s what it looked like running on a DEC PDP-10:Ĭolossal Cave Adventure: All those words add up to a lot of game. Although it was too large to be played on most microcomputers of the period, it was widely available on mainframe and minicomputer systems. In 1976, a Stanford University graduate student named Don Woods expanded Adventure with Crowther’s permission into what became known as The Colossal Cave Adventure. By all reports Crowther’s version was fairly rudimentary compared to later versions, but it caught on and spread from computer system to computer system. He wrote the game in part so that his daughters could play it and in part to indulge his love for Dungeons & Dragons. It was set in a huge cave not unlike Mammoth Cave in Kentucky, which Crowther had explored. In the early to mid 1970s, when microcomputers were still barely a blip on the computer hobbyist horizon, mainframe programmer and part-time spelunker Will Crowther logged on to a DEC PDP-10 and used his FORTRAN skills to write a computer game called, simply, Adventure. And it’s possible they’re more popular than ever. But after four decades, they’re still here. They’ve fallen in and out of fashion, they’ve gone through multiple visual and gameplay styles, and there have been periods when they’ve nearly disappeared altogether. Telltale Game’s Tales from the Borderlands: What adventure games look like in 2015.Īdventure games have gone through many permutations over the last 40 years.
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12/2/2023 0 Comments Directions to benchmark therapyThe expert panel of the 2018 ACC/AHA/MS Guidelines (Grundy et al., 2019) defines recommended intensity of statin therapy on the basis of the average expected LDL-C response to specific statin and dose. Intensity of statin therapy in primary and secondary prevention: It may not be appropriate to prescribe statin therapy for some patients (see exceptions and exclusions for the complete list). Adherence to statin therapy is not calculated in this measure. There is only one performance rate calculated for this measure: the weighted average of the three populations. Patients with an allowable denominator exception should be removed from the denominator of the measure and reported as a valid exception. Patients who meet the denominator criteria for inclusion, but are not prescribed or using statin therapy, will NOT meet performance for this measure unless they have an allowable denominator exception. Statin medication "samples" provided to patients can be documented as "current statin therapy" if documented in the medication list in health/medical record. Prescription or order does NOT need to be linked to an encounter or visit it may be called to the pharmacy. ONLY statin therapy meets the measure Numerator criteria (NOT other cholesterol lowering medications). Current statin therapy use must be documented in the patient's current medication list or ordered during the measurement period. If a patient has ANY previous laboratory result of LDL-C >= 190 mg/dL, report the highest value >= 190 mg/dL. The measure can be reported for all patients with a documented LDL-C level recorded as follows: In order for the patient to be included in the Initial Population, the patient must have ONE initial population-eligible visit, defined as follows: outpatient visit, initial or established office visit, face-to-face interaction, preventive care services, or annual wellness visit Initial Population Guidance for Encounter: If NO, patient does NOT meet Initial Population criteria and is NOT eligible for measure inclusion If YES, meets Initial Population 3 risk category Patients aged 40 to 75 years at the beginning of the measurement period with an active diagnosis of Type 1 or Type 2 diabetes at any time during the measurement period If YES, meets Initial Population 2 risk category Patients aged >= 20 years at the beginning of the measurement period who have ever had a laboratory test result of LDL-C >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia If YES, meets Initial Population 1 risk category Use the following process to prevent counting patients more than once.Īll patients who were previously diagnosed with or currently have an active diagnosis of clinical ASCVD, including an ASCVD procedure, before the end of the measurement period The initial population covers three distinct populations. Patients with end-stage renal disease (ESRD)Ĭenters for Medicare & Medicaid Services (CMS) Patients with active liver disease or hepatic disease or insufficiency Patients who are receiving palliative or hospice care Patients with statin-associated muscle symptoms or an allergy to statin medication Patients who have a diagnosis of rhabdomyolysis at any time during the measurement period Patients who are breastfeeding at any time during the measurement period Patients who have a diagnosis of pregnancy at any time during the measurement period Patients who are actively using or who receive an order (prescription) for statin therapy at any time during the measurement period Patients aged 40 to 75 years at the beginning of the measurement period with Type 1 or Type 2 diabetes Patients aged >= 20 years at the beginning of the measurement period who have ever had a laboratory result of LDL-C >=190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia *Patients aged 40-75 years with a diagnosis of diabetesĪll patients who were previously diagnosed with or currently have an active diagnosis of clinical ASCVD, including an ASCVD procedure *Patients aged >= 20 years who have ever had a low-density lipoprotein cholesterol (LDL-C) level >= 190 mg/dL or were previously diagnosed with or currently have an active diagnosis of familial hypercholesterolemia OR *All patients who were previously diagnosed with or currently have an active diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), including an ASCVD procedure OR Percentage of the following patients - all considered at high risk of cardiovascular events - who were prescribed or were on statin therapy during the measurement period: 12/2/2023 0 Comments Cookie places near meThough an easy-to-make dessert that’s delectable straight out of the oven, cookies are a treat that sometimes can’t always be shared with your loved ones in person. What’s the sweetest treat someone can receive on Valentine’s Day? Maybe a smooch from a loved one ranks at number one, but cookies are a close second. Nearly half of Americans would avoid stores without drive-thrus: pollĭomino’s customers can soon order pizzas on Uber Eats, Postmatesįood delivery apps to block driver wage hike: lawsuit Our delectable gourmet cookies or Logo cookies enable you to delight or thank prospects and customers as well as help you celebrate your employees.86ed! NYC to begin cutting back on ketchup, napkins in takeout orders Need a gift for your client or someone in the office? Cookies by Design has a variety of delicious corporate gifts to help you market your company in a truly unique and memorable way. We have dozens of cookie designs to satisfy your Christmas, Mother's Day, Fathers Day, and Valentine's Day gift basket needs, just to name a few! Corporate Gifts Cookies by Design makes it easy for you to send a truly special and memorable gift.īesides special occasions, we offer creative holiday cookie arrangements for those special days throughout the year. Our baskets, bouquets and trays are great for anyone, whether you are looking for a gift for her, a gift for him or for a very special child in your life. Whether you call it a cookie bouquet, a cookie gift or a cookie gram, we have arrangements that will brighten someones day no matter what the occasion! From wedding gift baskets and cookie favors to birthday gifts and thank you gift baskets to get well cookie gifts, we have the perfect gift ideas all in one place. Send a personal and creative gift today with a cookie delivery of delicious treats they will love! Cookie Gifts For All Occasions & Holidays In most areas we provide hand delivery of your gift to enhance the WOW factor! Need a last minute gift? We also offer same day gift delivery on many of our hand decorated cookie arrangements. Cookie Deliveryīrowse our wide selection of gourmet gifts and you will see we have cookies for any occasion. Create the perfect party gift with our custom cookie favors that are the same cookies as in our bouquets, only smaller. To make the gift extra special, we have the ability to create photo cookies with pictures of your loved ones or add a Build-A-Bear keepsake teddy bear to a bouquet. From cookie gift basket to cookie cakes, gourmet brownies or chocolate brownie truffles all of our delicious treats are made by hand to create a delectable gourmet gift that satisfies any sweet tooth. While cookie bouquets are our specialty, we also offer a range of other gourmet gifts. With over 30 years of experience baking the perfect cookie and creating our unique velvet smooth icing using our special recipes and quality ingredients, we have a gift that tastes as good as it looks! Our cookie arrangements can be customized for any occasion and can always be personalized with a name or special message. As the original cookie bouquet company we pride ourselves in preparing arrangements of fresh baked, hand decorated sugar cookies that are suitable for any holiday or occasion. During her pregnancy, Rowland attracted a lot of attention, especially after releasing nude photos. According to Rowland, Weatherspoon chose the boy’s name, and it has to do with family. The Destinys Child singer Instagrammed a sweet snap of 7-week-old Titan Jewell Weatherspoon sharing a sweet moment with his daddy Tim Weatherspoon.In. The Motivation singer tells PEOPLE her 2-year-old son, Titan. Kelly Rowland and her husband, Tim Weatherspoon, welcomed their first child together, Titan Jewell, on November 4, 2014. Kelly Rowlands little boy is just too cute. Set to the tune of Jay Z and Kanye West’s “New Day” from their Watch The Throne album, Weatherspoon taps Hov’s lyrics for a message to his son, which he wrote out in the accompanying caption: “I just wanna take ya to a barber Bondin’ on charters, all the sh*t that I never did Teach ya good values, so you cherish it Took me some 26 years to find my path My only job is cuttin’ the time in half So at 13 we’ll have our first drink together Black bar mitzvahs, mazel tov, mogul talk Look a man dead in his eyes So he know you talk truth when you speak it, give your word, keep it………….” #WeatherspoonMen #WeatherNotWither #TitanJewell#TitanDad #BabyTyTy #TJW #MeAndMyGuy #MamasBoy #ButHeLikesHanginWithDad #WishMyDadWasHere #YesThatsAWarholOnMyWall Baby Ty was born last Tuesday (Nov. He’s awesome and I’m so blessed to have him, she says, adding that husband Tim Weatherspoon is an excellent dad. Kelly Rowland’s husband Tim Weatherspoon posted the couple’s first photo of their son, Titan Jewell Weatherspoon, to Instagram on Friday (Nov. 'On the 21st day, of the 21st year, of the 21st Century, Noah Jon Weatherspoon greeted us,' Rowland, 39, wrote on social media alongside a photo of her newborn and her 6-year-old son, Titan Jewell. In the image, Titan appeared crouched down and wearing a green camo shirt, similar pants, and dark green shoes while looking directly at the camera with a serious. A video posted by Tim Spoon on at 5:03pm PST On November 4, Tim Weatherspoon took to Instagram to upload a photo of his and Kelly Rowland’s son, Titan Jewell, as a way to commemorate the boys’ 6th birthday. Updated on Decem11:44PM EST Jason Merritt/Getty Just call it destiny: Kelly Rowland is a mama The singer welcomed her first child with husband Tim Weatherspoon on Tuesday, Nov. 12/2/2023 0 Comments Iphone hacked remotelyConclusionĪlthough it is possible to hack an iPhone, you can keep it secure by following the security measures highlighted in this article. It can also open the door to malware and cyber-attacks. Jailbreaking is a process to remove Apple’s security restrictions on an iPhone to provide more freedom for customization. Are Jailbroken iPhones More Vulnerable to Hacking? If you’re confident an app has malware, uninstall it and report it to Apple. To spot such apps, you can check for any irregularities in battery usage, iPhone storage, and access permissions. How to Spot and Uninstall Apps with Malware?Īlthough the App Store is strictly monitored, sometimes a legitimate-looking app that contains malware might fall through the cracks. Here are two common questions related to iPhone security. Want more advice from Apple on how you can keep your iPhone secure? Check this page for tips on maximizing the security of your Apple ID and this page for additional tips to protect your iPhone. Check this article to learn more about Find My iPhone. Beyond just helping you track your iPhone, you can also use it to remotely wipe your iPhone’s data to ensure that it doesn’t fall into the wrong hands.Īlthough it’s enabled by default, to double-check it, open Settings, tap your name, Find My, Find My iPhone, and ensure that Find My network is toggled on. Tip #3: Enable the ‘Find my iPhone’ Featureįind my iPhone can come in handy in many cases. Visit this page to learn more about your iPhone’s security features. If you want to double-check who you share your data with, you can also look into Safety Check in the Privacy & Security page in Settings. Here, toggle on Block Popups, Prevent Cross-Site Tracking, and Fraudulent Website Warning. To get security recommendations from iOS, open the Settings app and go to Passwords. So, it has many built-in security features that you can use. IOS has been developed from the ground up with security and privacy in mind. Tip #2: Enable Built-In Security Features If you stay mindful of these tips, you’re already much ahead of most people in securing your iPhone and online data. To do this, open Settings, go to General and tap on VPN & Device Management. Remove bogus configuration profiles from your iPhone.Only use trusted WiFi networks and charging stations (use a VPN if possible).The same also extends to your other online accounts. Change your Apple ID password every six months and enable two-factor authentication.Also, don’t write your passwords on post-it notes. Never share security details with anyone, like your Apple ID credentials or login passcode.Never tap on any unrecognized links sent via text messages or email.Most cyber security threats can be avoided if you maintain digital hygiene. Even if your iPhone has been hacked once, follow these to ensure it doesn’t get hacked again. Here are three proven tips for securing your iPhone and its data. Follow the steps in the above section and read on for more security tips. Apps opening and closing automatically: Unless there’s the ghost touch issue on your iPhone, apps opening and closing automatically also indicate that your iPhone might be hacked.ĭid you notice any of these signs on your iPhone? If yes, your iPhone might be hacked or infected with malware.If you see any unrecognized purchases, your Apple ID might be hacked. Unrecognized purchases made using your Apple ID: Go to this page and check your purchase history.Unusual system, battery, and mobile data usage: If your iPhone has malware, it might use an unusually high system resource level.Unless you are using an app that legitimately requires them, this might indicate the presence of spyware. Unexpected orange or green indicator: iOS shows an indicator on the screen when an app uses the microphone (orange) or camera (green).If you see any unrecognized devices, tap on them and choose Remove from Account. Unrecognized devices in Apple ID: Open Settings, tap your Apple ID name, and scroll down to view devices.Here are some signs you should keep an eye out for. It’s much more subtle than most people think. It’s not always easy to tell when your iPhone might be hacked. Once done, you can contact Apple Support for further instructions. This mode will limit certain features on your iPhone to reduce the attack surface. Open Settings, go to Privacy & Security, and Lockdown Mode. Restart your iPhone ( force restart if necessary).If you think your iPhone has been hacked, don’t panic. Are Jailbroken iPhones More Vulnerable to Hacking?įirst Steps to Follow If You Think Your iPhone Has Been Hacked.How to Spot and Uninstall Apps with Malware?. Tip #3: Enable the ‘Find my iPhone’ Feature.Tip #2: Enable Built-In Security Features.First Steps to Follow If You Think Your iPhone Has Been Hacked. 12/2/2023 0 Comments Velocity stacks r1Available now for your 2009-2014 Yamaha R1. Yamaha R1 Velocity Stack Kit for the 2002-2003 AB003 - 93.95 : Starcycle USA, The Exhaust King Pro Circuit Pro Design Pro Filter Pro Grip Pro Moto Billet Pro Pad Pro-One Perform. These stacks were specifically developed on the Graves Yamaha Superbike give our riders the drivability needed to win races. The shorter than stock lower stacks feed the R1’s appetite for big air when the upper stacks raise improving top end power. The staggered tops allow the cylinders to share the available volume of air in the R1’s air-box evenly at low and mid range RPMs. This stack kit improves power throughout the entire RPM range. Made-to-Order Timeline All new motorcycle part orders are fulfilled in 1-2 weeks All new Onewheel bumpers are fulfilled in 1-2 weeks Thank you for your. The upper stacks must be used with either our flashed ECU with the appropriate settings, or a YEC ECU and correct setting will be supplied to customer upon purchase.ĭeveloped by Graves for your Cross Plane Crank Yamaha R1. See below for full details and restrictions on these parts when used with stock pieces. This "Upper" or "Top" velocity stack is sold seperately from the lower billet machined piece shown in picture ( Lower Part # ABY-09R1-REVB). MWR-VS-960 : Completely new velocity stacks for the new 2020 R1, lower stacks / upper stacks & bolts.Graves Motorsports Yamaha R1 Top Velocity Stacks for the 2009-2013 models. MWR-VS-900: Finally it is done, We to be sure it would be better than the competition!!! They have been tested them on track by World Supersport 600 teams to let them compare the new MWR VS against the YEC and all of them choose for these configuration.No power curves are available yet because our development was based on track data and feedback from the teams and comparison against others Due to the construction of the stacks it is quite well possible you need to leaner the fuel from the upper injectors (high revs) of the to two outside cylinders (less fuel blown away so more effective …. Just put the TOCE exhaust on it and love it. I got tired of tuners destroying my engine, therefore I build the engine myself every single piece. The installation instructions are also included, which is also included with each set. Has any put aftermarket velocity stacks on their r1 Thinking about it for my 07. The spec for the engine is given to me by Pete Beale from UK, and I have promised not to disclose it. Only the YEC stacks are very difficult to obtain and cost around € 2500,. The first tests have already been done by WSBK & BSB teams showing that the MWR stacks deliver the same power as the official YEC stacks…. MWR-VS-960 : Completely new velocity stacks for the new 2020 R1, lower stacks / upper stacks & bolts. Charging up the projectile increases the initial launch velocity of the. I have an 05 R1 as my trackbike and the Graves stacks did make a noticeable. Once the cooldown period is finished, all stacks are recharged at once. Triumph Daytona 675 / Street Triple 675 There is a Ten Kate set on ebay at the moment Velocity Stacks John.Jofama 2019 Range of Motorcycle Clothing Clearance.Lindstrands Range of Motorcycle Clothing.Halvarssons Range of Motorcycle Clothing MWR Velocity Stacks for Yamaha R1 (15-19) was Special Price 899.99.Bonamici Chain Adjusters, Paddock stands and Bobbins.EVR Overbore Kit for Ducati 748 to 853cc.Introducing the new Weather Protector Seat cover Graves Motorsports Yamaha R1 Velocity Stack Kit for the 2002-2003 model sport bikes.LUIMOTO SEAT COVERS & TANK LEAF PRODUCTS.Aprilia RS660 HIGH PERFORMANCE VELOCITY STACKS.Speedycom Performance Ltd > Yamaha Velocity stacks > High Performance Yamaha Velocity Stacks 12/2/2023 0 Comments Samsara panic buttonVerizon will also tie you into a three-year contract. You can also create service plan templates to calculate maintenance costs and how often you should do them. In case of a faulty system, it will automatically sync this information to your records and suggest the nearest maintenance centers. Speaking of, your fleet maintenance records are all intact with Verizon’s system. If you ever miss a check-up or scheduled maintenance, it will automatically reflect on your fleet maintenance records. So, if a faulty system lights up, you can receive vehicle diagnostic reports in a snap! Moreover, it sends automatic alerts if it detects any damage. It helps you schedule maintenance checks regularly to ensure all your vehicles are in tip-top shape before setting off. Verizon has an impressive 4.7/5 score in our research, and it very much deserves the best overall title. However, active trackers are more expensive than passive trackers as it typically includes a monthly fee on top of transmission and real-time data fees. Plus, deliveries and stolen or missing vehicles can be tracked. The pros of an active tracker is that you receive real-time data so fleet managers can plan better routes at short notice and monitor risky driver behaviour. Transmission time will depend on each system but some of the better systems will transmit every 60 seconds. Active trackingĪn active GPS tracker can record, store, and transmit information about a vehicle in real-time. However, a passive tracker cannot provide instant feedback or stats, you can't monitor a driver or vehicle in real-time and you can't track a stolen or missing truck. The pros of a passive tracking system include providing exact records of vehicle location, monthly reports, and its cheaper as you don't need a subscription fee. With passive systems there is no transmitter to send information back to the system while the vehicle is on the road. Passive trackers stores the GPS data which is then downloaded once the vehicle returns to the office or base. There are two main types of GPS tracking for trucks: passive and active. What are the different types of GPS tracking systems for trucks? Browse our collection of minimalist wallpapers today and embrace the beauty of less being more. Let our collection inspire you to create a space that exudes simplicity, elegance, and timeless style. For a dynamic, modern living room, a design with a splash of car-inspired black or a hint of blue could make a bold statement. A simplistic design with subtle hues, like sage green or white, might be the perfect fit for a peaceful bedroom. The array of available colors, from the stylish and calming sage green and blue to the timeless black and white, offers many styling possibilities.Ĭhoosing a suitable minimalist wallpaper involves balancing your personal style and the aesthetics of the space. Aesthetic Halloween Pumpkin October Wallpapers. Bundle of Four Simple Autumn iPhone Wallpapers. 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Minimalist wallpaper allows for a powerful transformation of your interiors, elevating the space with its simple yet sophisticated design aesthetics. 12/2/2023 0 Comments Postman console outputLogs from console.log(), (), console.warn() and console.error() and asynchronous requests from test or pre-request scripts.The network information such as IP addresses, ciphers, and protocols used.The proxy configuration and certificates used for the request.The raw response sent by the server before it is processed by Postman.The primary request that was sent, including all underlying request headers, variable values, redirects, etc.The Postman console logs the following information: Using the consoleĮvery request sent via Postman is logged in the console, so you can view the detail of what happened when you sent a request. If you think the issue may be with Postman itself, the DevTools console provides internal debugging information you can also check out. The Postman console helps debug your requests when an API is not behaving as you expect. Postman supports TLS version 1.2 or higher, which may not be supported if you are using an older browser or operating system. If your server sends incorrect response encoding errors, or invalid headers, Postman may fail to interpret the response.Try increasing the timeout to avoid this issue. If you configure a very short timeout in Postman, the request could be timing out before completion, resulting in an error.If you believe this is happening, get in touch with the Postman team on the GitHub issue tracker. You can confirm this by checking your server logs (if available). It is possible that Postman might be making invalid requests to your API server.Check whether you're accidentally using instead of in your URL (or vice versa).Unresolved request variables can result in invalid server addresses. If you are using variables or path parameters with your request, make sure the final address is structure correctly by opening the Console, which will display the URL your request was sent to when it executed.You can add a client certificate in the Postman Settings. Client certificates may be required for your API server.Use the Postman Console to ensure that the correct SSL certificate is being sent to the server. If that does not help, your server might be using a client-side SSL connection, which you can configure in Postman Settings. You can turn off SSL verification in the Postman Settings. You may experience issues using HTTPS connections.The Postman Console will provide debugging information regarding proxy servers. By default, Postman uses the proxy settings configured in your operating system's network settings. If you are using a proxy server to make requests, check your configuration.If this happens you will need to contact your network administrators for Postman to work. Some firewalls may be configured to block non-browser connections. Check your connection by attempting to open a page in your web browser.
12/2/2023 0 Comments Same day pcr covid test atlantaFour days later, he returned to the ED with encephalopathy, progressive generalized weakness, and inadequate oral intake requiring admission to the inpatient medical ward. He was discharged from the ED with oral antibiotics to his assisted living facility (ALF). He did not initially undergo a NP RT-PCR for SARS-CoV-2 on admission due to restrictions on testing at that time. He was diagnosed with a possible urinary tract infection owing to an otherwise negative workup including a computed tomography (CT) head and chest radiograph (CXR). Ī 90-year-old male with hypertension (HTN), well-controlled type 2 diabetes mellitus (DM2), hyperlipidemia (HLD), coronary artery disease, mild Alzheimer's dementia, and chronic kidney disease (CKD) stage 3 presented to the emergency department (ED) with generalized weakness and recurrent falls for the past few days. The following case is of an elderly male who presented with metabolic encephalopathy and failure to thrive that was found to have persistently positive NP RT-PCR for SARS-CoV-2 over several weeks despite a lack of symptoms typically attributed to SARS-CoV-2 infection. We hope a deeper understanding of testing validation, and results will improve our medical communities' ability to make a true diagnosis of clinically significant COVID-19 disease or lack thereof and open up future research of more validated tests. In an effort to guide clinicians through this unparalleled time, we present three case reports to support detailed and individualized interpretations of patient presentations in the context of both positive and negative RT-PCR tests for SARS-CoV-2. We advocate a thorough assessment of a patient's clinical picture without isolated interpretation of RT-PCR test results for SARS-CoV-2. This article brings forth the potential for misinformation and misinterpretation that could lead to undesired patient outcomes. It is important for all providers to understand these constraints and the potentially misleading test results in the clinical context of their patients. Paramount to this topic is the often misquoted “sensitivity and specificity” of the RT-PCR detection assays, a nonexistent test property for SARS-CoV-2 due to the lack of a gold standard for verification and validation. We aim to lay an intellectual framework for the rapid expansion of SARS-CoV-2 testing via EUA FDA “authorized” studies and emphasize the limitations of rapid bedside interpretation. In an unprecedented world of SARS-CoV-2 infection, a medley of non-FDA-approved tests has been thrust upon providers who are now challenged with their complex and potentially inconsistent interpretation. Here we present three challenging cases requiring cautious interpretation of the newest generation of RT-PCR molecular detection assays, highlighting the major challenges faced by providers treating patients potentially infected with SARS-CoV-2. These tests therefore do not have clinically applicable sensitivity and specificity because they lack a “gold standard” for diagnosis. Despite the exceptionally high rates of agreement, caution is advised as the RT-PCR tests approved under the COVID-19 EUA are in vitro analyses developed with samples artificially doped with SARS-CoV-2 RNA. These newly developed and approved SARS-CoV-2 RT-PCR tests boast impressive positive and negative agreement rates nearing 100%. Expectantly, the development and deployment of SARS-CoV-2 testing including RT-PCR expanded rapidly in the weeks following the EUA expansion. Unfortunately, effective mitigation efforts were thwarted early in the outbreak resulting in an expansion of the initial EUA on February 29, 2020, to improve accessibility to in vitro diagnostic testing. On February 2, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that the public health emergency justified the development and emergency use of “in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19” by activating the Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act. The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is estimated to have affected 6.2 million people in the United States and 27.5 million people worldwide as of September 9, 2020. |
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