UK medicines agency seizes HIV home-test kits over false result risk. More than 100 Hightop brand kits, which have not met EU regulations, seized as agency warns consumers against using them

More than 100 HIV home-testing kits have been seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) amid fears over their reliability.

The agency believes it has seized all stock of the Hightop HIV/Aids home-test kit from UK suppliers but is warning consumers against purchasing the product online or using it, if already purchased, because of the potential for false results.

People are advised to always check before using a HIV kit that it carries a CE mark, which indicates that it complies with EU safety, health and environmental requirements.

The Hightop tests, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark, meaning they have not met a number of regulatory requirements concerning test performance, labelling and instructions for use.Advertisement

MHRA’s director of devices, John Wilkinson, said: “People who buy a self-test kit online or from the high street should know what they are buying is safe and reliable. Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.

“If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional.

“We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.”

The MHRA seized 114 of the products in question from two UK-based suppliers and all sales of the tests into the UK market have been stopped by the manufacturer.

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It says consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with MHRA. In the UK online pharmacies must be registered with MHRA and display the European common logo on every page of their website.

Qingdao Hightop Biotech, which specialises in medical tests and equipment, stopped supplying its HIV kit to the UK market after being contacted by the MHRA. According to the Chinese company’s website, its annual revenues amount to between $5m and $10m (£4m-£8m).

The UK and Europe would not appear to be key markets for Qingdao Hightop Biotech: it states that 88% of its business is domestic, with its next biggest markets the Middle East (4%) and Africa (2.5%)

It is unclear why the HIV test did not carry a CE mark as many of its other kits, including tests for pregnancy, fertility, malaria, other sexually transmitted diseases and recreational drugs, do carry the standard.

HIV self-testing kits sold and advertised for sale in England Scotland and Wales must be CE-marked.

Cary James, the head of health promotion at the Terrence Higgins Trust (THT), said: “Home self-test kits for HIV and STIs have many benefits, including letting people test in their own space, in their own time, on their terms. However, we are extremely concerned to see unregulated produce on the market and urge anyone considering a test to only use those with a CE mark. Anyone taking a test without a CE mark risks their own health and that of others.”

The first legally approved HIV self-testing kit, the BioSure HIV Self Test, went on sale in the UK in 2015. It has a 99.7% accuracy rate. Home kits have been hailed as a way of increasing early diagnosis. In the UK, 39% of people living with HIV are diagnosed late, leaving them with shorter life expectancies, according to the National Aids Trust.

The THT says there are more than 100,000 people living with HIV in the UK and about a quarter of them do not know they are HIV positive, meaning they are not receiving treatment.

Dr Kirsty Foster, a consultant in STIs and blood-borne viruses at Public Health England, said: “HIV tests are free and testing through a sexual health clinic is strictly confidential. We would encourage anyone who thinks they may have been at risk of HIV to get tested as soon as possible, as early diagnosis and treatment are highly effective in helping people with HIV remain in good health long term and reduce the risk of passing the virus on.”

人在马来西亚,需要检测某某是否吸毒?没问题。

如果你的公司要聘请新雇员,而新雇员那行工作大多数人服毒的话,你需要检验他人是否服毒
若你自己有服用毒品的习惯(比如吸大麻),公司要检查你,看看你有没有吸毒,那我建议你查查看自己的尿液会不会出卖你

尿液毒品检测纸

对,就是用毒品检测纸来判断!只需十分钟。

十分钟内可以知道人家有没有服用毒品,十分钟内可以知道你的尿液含有没有毒品的痕迹。

我们有卖几种。一下这个是六合一尿液毒品检测纸,就是可以测试人家是否有服用这六种毒品,卡式的。用法很简单:用杯子收集尿液,然后用开测试卡的盖子,把测试纸的部分浸泡在尿液里。三分钟后,你就会看到有线条出现。

另一个更简单,杯式的。这款可以检测大致上所有在马来西亚的毒品。用户只需要转开盖子,尿尿在杯子,等五分钟,检测结果就揭晓了。方便,快速,又简单。

如果你只需要检测某种毒品。可以用一下这种。只需把它浸泡在尿液里五秒钟就行了。

我们人在马来西亚的吉隆玻,检测纸有现货。有询问可以联络我们!

9 symptoms that you may be infected with AIDS

1. Fatigue and night sweats: After HIV infection, patients often feel fatigue and night sweats. They usually have no strength and sleep at night, which indicates that there is a problem in the human body.

2, rash: rash is one of the most important symptoms of early HIV infection.

3, lymph node enlargement: diameter 0.5cm or more, slowly increase, tough, slidable round hard core, the most common neck.

4, oral Candida infection: commonly known as thrush, thrush is the most common AIDS opportunistic infection, also known as Xuekou disease.

5, rapid weight loss: rapid weight loss is a common problem after HIV infection. If you don’t lose weight, a rapid weight loss is a serious problem.

6, diarrhea: diarrhea is one of the most annoying AIDS symptoms, because diarrhea can lead to dehydration and electrolyte imbalance, opportunistic infection into the intestines may occur diarrhea.

7, fat metabolism disorders and lactic acidosis: the side effects of AIDS drugs is no secret, the side effects of drugs are fat metabolism disorders. After taking AIDS drugs for a period of time, in addition to typical symptoms such as nausea and diarrhea, patients may experience muscle pain, fatigue, increased nausea and vomiting, abdominal pain and other symptoms. These symptoms mean that patients are likely to have symptoms. Lactic acidosis has occurred.

8. Depression and headache: The dual causes of psychology and physiology will cause nervous system problems in people living with HIV, psychological stress caused by HIV infection, and damage to brain cells by HIV.

9. Peripheral neuropathy: Peripheral neuropathy is a common symptom after HIV infection. Peripheral neuropathy can cause damage to the hands, feet, mouth and lips, but this damage may not only be the result of HIV, most In the case, it is caused by side effects of some AIDS drugs.

What are the Signs Of HIV In The Mouth

The signs of HIV in the mouth are as below:

Dry Mouth and Tooth Decay
Candidiasis (thrush)
Canker sores (apthous ulcers)


Cold sores (herpes simplex)
Gum disease (periodontitis)
Hairy leukoplakia
Kaposi’s Sarcoma
Enlarged saliva glands
Shingles (herpes zoster)
Oral warts (human papillomavirus):

Other than that you will notice:

Swollen lymph nodes on the side of the neck or under jaw: Swollen lymph nodes on the side of the neck or under jaw are the most common. They may represent an infection around that area, such as a tooth infection or abscess, throat infection, viral illness, or upper respiratory infection

 

 

Oraquick HIV Saliva Test Kit Malaysia

Oraquick the only saliva HIV Test Kit you can perform in home. It’s USFDA certified perfectly safe and accurate for those who don’t prefer blood testing.

According to The Centers for Disease Control and Prevention (CDC), at least one in seven Americans living with HIV don’t even know it! This is quite alarming since such individuals are likely to transmit the virus to other partners without knowing. Besides, it is necessary to find out one’s HIV status to allow for earlier treatment to extend life expectancy as well as protect their loved ones from contracting the infection.

A recommendation by the same institution is that everybody between the age of 13 and 64 must get tested at least once in their lifetime. Regular testing is, however, recommendable especially when indulges in unprotected sex with multiple partners or uses drug injections.

It is not surprising that many people fear to present themselves to the voluntary counseling and testing centers for privacy reasons. However, this should never be an excuse to not getting tested and knowing your status. Currently, home HIV tests are available. The two common home HIV tests are the Home Access HIV-1 Test System and OraQuick In-Home HIV test. These are available online and locally available in chemists and hospitals.

If you choose to order your home test online through phone, always ensure that the HIV test is FDA approved beforehand to ensure safety and accuracy are guaranteed.

Home Access HIV-1 Test System

This is a home collection kit which allows you to do a personal test on your blood sample and getting it delivered to a licensed lab where you will call to get your results after a day or so. The amazing fact about this test is that it is anonymous and follow up test can be performed immediately if the result turns out to be positive. After the process, the manufacturer offers confidential counseling and referral treatment. This type of test on a sample of blood collected at home finds infection later than tests undertaken at the lab using blood from the veins but much earlier compared to test conducted on oral fluids.

An excellent place to order this type of HIV test kit is Amazon among other reputable sites. However, Home Access Health Corporation has strongly come out as among the best places to seek the HIV-1 test system and be guaranteed over 99.9 percent accuracy within a day. They have been FDA approved and offer phone counseling. This type of test has been evaluated in various multi-center clinical studies in the US and proven to be as accurate as tests done by doctors and hospitals.

Mylan signs HIV test commercialization deal with Atomo Diagnostics

Firstly, i would like to congratulate both Atomo Diagnostics and Mylan for forming these powerful alliance to help the lower income people to have access to these HIV test kit.

And another congratulations to Atomo Diagnostics for secured the European CE-Mark in October last year. The test is a qualitative immunoassay designed to detect antibodies to HIV type 1 and type 2 in human whole blood.

For those who do not know, Atomo HIV Test kit is indeed “very canggih” unique i would say, because personally i like Atomo HIV test kit design, thanks to the Founder and CEO John Kelly.

Mylan received exclusive rights for commercialisation of in-vitro HIV rapid diagnostic tests in more than 100 countries across Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America.

HIV testing rates have improved but expanding access to the tests is still a challenge in certain countries.

Mylan noted that offering point-of-care self-tests in community-based settings can increase the proportion of people aware of their HIV status, in turn enabling treatment or prevention.

Through the new partnership, the companies will provide all-in-one test devices, which are designed to deliver better functionality and are easy to use compared to existing multi-component rapid diagnostic tests.

Mylan CEO Heather Bresch said: “Our partnership with Atomo to supply HIV rapid diagnostic tests for self-testing is an important step in our collective goal of preventing HIV infections and expanding treatment.”

HIV Self Test by Atomo Diagnostics secured the European CE-Mark in October last year. The test is a qualitative immunoassay designed to detect antibodies to HIV type 1 and type 2 in human whole blood.

Atomo Diagnostics founder and CEO John Kelly said: “This strategic partnership will mean that the products designed by Atomo can be introduced to more than 100 countries, so that millions of people will have access to award-winning rapid tests.

“We believe that Mylan is the ideal partner to ensure that our HIV self-test products have maximum impact in the fight against HIV/AIDS.”

Mylan intends to globally launch the Mylan HIV Self-Test early next year.

Let me know your comments about Atomo HIV Test kit.

 

Knowledge of the Day 

“Global pharmaceutical company Mylan launch two new HIV treatments, Symfi Lo™ and Cimduo™, which were approved in February by the U.S. Food and Drug Administration (FDA). “

TRUSTline HIV Ab/Ag 4th Generation HIV Test Kit

The TRUSTline HIV-Ab/Ag 4th Gen Rapid Test detects HIV p24 in addition to IgG and IgM enabling HIV infection to be caught as early as 16 days post-infection.

Convenient that allows you to screen for HIV at the comfort & privacy of your home.

Sensitivity: 100 %, Specificity: 99.84 %

Reliable and fast results in 15 minutes

A lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 & 2 virus and HIV-1 p24 antigen in human serum, plasma or whole blood.

  • 4th Generation HIV test to detect p24 in addition to IgG and IgM for early detection of HIV infection
  • HIV 4th Gen test utilizes recombinant gp-120-41, gp36 and anti-p24 antibodies for earlier and more accurate detection of HIV infection
  • Evaluated by NIB
  • Only 20 µL whole blood specimen required or (0.4 drops – 1 drop of whole blood)
  • Results available within 15 min to allow prompt action to be taken at the point of care
  • Performance validated with BBI low titre panel and Chinese FDA HIV Ab Panel
  • Sensitivity: 100 %, Specificity: 99.84 %

 

 

Urit 11G Urine Reagent Strips

For Instrumental used only

For Uritest -50/500/500B, URIT-30/50/180/330/500B/500C urine analyzer

No of strips in box: 100

Much higher reliability with Ascorbic Acid parameter

Unique check block on every strip

Unique check block on every strip

URIT 10G/11G: used for URIT-50,URIT-180,URIT-500B,URIT-500C and URIT-30 urine analyzer

  • Leukocyctes
  • Ketone
  • Nitrite
  • Urobilinogen
  • Billirubin
  • Protein
  • Glucose
  • Specific Gravity
  • Blood
  • pH
  • Ascorbic Acid

 

 

Urit 10G Urine Reagent Strips

For Instrumental used only

For Uritest -50/500/500B, URIT-30/50/180/330/500B/500C urine analyzer

No of strips in box: 100

Unique check block on every strip

URIT 10G/11G: used for URIT-50,URIT-180,URIT-500B,URIT-500C and URIT-30 urine analyzer

  • Leukocyctes
  • Ketone
  • Nitrite
  • Urobilinogen
  • Billirubin
  • Protein
  • Glucose
  • Specific Gravity
  • Blood
  • pH