Tag: 1/11/21

Categories : COVID Lab Tests and ImagingTags :

COVID Variants May Increase False Negative Results, FDA Warns

On By ModernMedia

The UK variant of the SARS-CoV-2 virus, known as B.1.1.7 could affect the accuracy of certain molecular COVID tests, causing increased false negative results, the US Food and Drug Administration (FDA) has warned.

A false negative from the UK variant could happen if the variant’s mutation happened to be in a part of the virus’ genome that was assessed by that test. However, genetic tests that target multiple parts of the virus genome are less likely to be affected by the new variants, the FDA advises.

Although the possibility of false negative results are to be expected from almost all tests, the effect of the COVID variants could impact the ability to properly monitor the disease, as well as complicating diagnosis.  

The FDA issued an alert on Friday, saying that they monitor tests which have received an Emergency Use Authorisation (EUA). They highlight three tests as being affected, with potentially less sensitivity to the mutations:

  • Accula SARS-Cov-2 Test, from Mesa Biotech
  • TaqPath COVID-19 Combo Kit, from Thermo Fisher Scientific)
  • Linea COVID-19 Assay Kit, from Applied DNA Sciences

However, the warning for Accula test was a result of “an abundance of caution”, and the latter two assess multiple genetic targets, so they are not likely to be impacted. The FDA issued recommendations for the users of these devices.The FDA’s warning was prompted by computer simulations showing reduced efficacy in certain tests for the virus variant.

In their press release, the FDA did not specifically mention whether any tests may be affected by mutations in the South African virus variant.

Source: MedPage Today

Categories : Allergies Uncategorized UrogenitalTags :

New Research Links Bladder Pain Flare-ups to Pollen

On By ModernMedia

High pollen counts have long been associated with allergic rhinitis with its well known symptoms such as itching eyes, running nose and sneezing, but now new research suggests that it may be aggravating a completely unexpected condition: chronic bladder pain.

In the United States, more than 10 million people are believed to suffer from urologic chronic pelvic pain syndrome (UCPPS) – a mysterious cluster of problems which include bladder pain syndrome and interstitial cystitis in women, chronic pelvic pain syndrome, and in men, chronic prostatitis.

Researchers regard it as “one of the most frustrating urologic conditions to understand and manage”, requiring a multidisciplinary and multimodal approach to management. However, it has been known to be associated with flare-ups of allergies, prompting Washington University epidemiologist Siobhan Sutcliffe to lead a team to investigate a possible connection. Their study recruited 290 participants diagnosed with UCPPS, and tracked pollen levels from three days before and on the day against UCPPS symptoms. Daily pollen counts did not correlate with UCPPS symptoms, but in participants with when pollen count was medium or high, there was a significant association with symptoms. The mast cell activation involved in pollen allergies release histamines which may be a contributing factor in UCPPS. Evidence for this comes from animal studies which have shown that exposure to histamine makes the bladder hypersensitive. Histamines also stays resident in the bladder longer than in the bloodstream as they are excreted via urine.

Sutcliffe said: “Our study provides evidence to suggest increased pollen counts may trigger symptom flares in people living with UCPPS.”This research may bring an avenue for some now forms of relief to UCPPS sufferers, but further research is needed to eliminate confounding factors, such as environmental factors associated with high pollen counts – strong levels of wind and thunderstorms may trigger pollen allergies but also exert some other kind of separate influence.

“Patients may benefit from taking antihistamines on days with high pollen levels, or from allergy testing and immunotherapy,” concluded Sutcliffe.

Source: Science Alert

Journal information: Javed I, Yu T, Li J et al. Does Pollen Trigger Urologic Chronic Pelvic Pain Syndrome Flares? A Case-Crossover Analysis in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network. Journal of Urology. 2020. doi:10.1097/ju.0000000000001482