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Product Description  产品简介

Gmate Saliva Antigen Test Kit is a rapid test to detect specific antigens of SARS-CoV-2 present in human saliva. This test kit is user-friendly and non-invasive. It allows self testing of Covid-19 antigen performed anywhere, without needing to get tested at a healthcare facility.

Gmate 唾液抗原快速测试剂盒是一种快速测试,用于检测人类唾液中存在的 SARS-CoV-2 特定抗原。这个检测试剂盒方便使用且非侵入性。让使用者在任何地方都可以进行自我检测,无需在特定的冠病检测地点进行检测。

Product Features 产品特点

  • Made in Korea 韩国制造​

  • Easy to use 容易使用

  • Affordable Price 价格亲民

  • Fast & Convenient 快速方便

  • IMR certified:
    Sensitivity 敏感性: 91%
    Specificity 特异性: 100%

  • MDA approved 大马医疗器械管理局批准

Box contains 盒子里面含有

  1. Test Kit 试剂盒

  2. Reagent Container 试剂容器

  3. Funnel 漏斗

  4. ​Cap 盖子

Gmate Antigen Saliva Self-Test Kit

Gmate Saliva Antigen Test Kit test is registered and approved by the Medical Devices Authority (MDA) which is the medical devices division under the Ministry of Health.

Gmate 唾液抗原快速测试剂盒已获得大马卫生部所属的医疗器材管理局 (MDA) 注册和批准。

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Accuracy  准确性

Gmate Saliva Antigen Test Kit is certified by the Institute of Medical Research (IMR) that is has 96% accuracy based on 91% sensitivity and 100% specificity.

Gmate 唾液抗原快速测试剂盒经由医药研究所认证拥有 91% 的敏感性及 100% 的特异性,整体准确性达 96%。

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How to Use Gmate Saliva Antigen Test Kit
如何使用 Gmate 唾液抗原快速测试剂盒

Gmate Antigen Saliva Self-Test Kit
Gmate Antigen Saliva Self-Test Kit

Interpretation of Test Results  测试结果解释

Gmate Saliva Antigen Test Kit

Positive Result
Two distinct red lines appear in “C” and “T” Region. The lines can be distinct or faint.

  • RT-PCR test is still required for a confirmation of a Covid-19 case.

  • Results shall be reported to KKM on MySejahtera App.
    Open the App>> Press Helpdesk>> Start>> Select F “I am Covid-19 Positive and awaiting call from MOH”

Negative Result

One red line appears in “C”  region and no red line appears on “T” region.

  • You are advised to continue monitoring for symptoms if you suspect you might be exposed to the virus as there is a chance for a false-negative result.

  • Symptomatic people with negative results are advised to do a RT-PCR test as confirmation.

 

Invalid Result
If you do not see any lines, or one line by T, it is an invalid result. The test did not work.

  • Please contact the pharmacy or clinic for your replacement.

** Due to its limitation in detection range and sensitivity, RTK-Antigen test is used as a screening test and RT-PCR is used as confirmatory test to define a Covid-19 case.

结果呈阳性   

控制线 “C” 及测试线 “T” 各别出现红线,无论线条颜色深浅

  • 仍需要 RT-PCR 检测来确认是否感染冠病

  • 需通过 MySejahtera 应用程序向卫生部报告
    打开应用程序 >> 选择 Helpdesk >> 点击 Start >> 选择 F “I am Covid-19 Positive and awaiting call from MOH”

结果呈阴性

控制线 “C” 出现红线,测试线 “T” 没出现红线

  • 如果您怀疑自己可能接触过病毒,建议您继续监测症状,因为有可能出现假阴性结果

  • 建议有症状但出现阴性结果的人再次进行 RT-PCR 检测来确认

 

无效结果

两方都没出现红色线或只有测试线 “T” 出现红线

  • ​联系购买的药剂行或诊所退换,并重新做检测

 

** 由于其检测范围和敏感度有限,因此快速抗原测试只被作为筛查测试,而RT-PCR则作为确诊新冠肺炎病例的测试。

How to Purchase  如何购买

Gmate Saliva Antigen Test Kit is now available at AM PM Pharmacy. Get yours now!

Gmate 唾液抗原快速测试剂盒现已在维康保健西药行内出售。立即购买!

 

Gmate Covid-19 Saliva Antigen Test Kit 

1’s : RM 39.90

6’s : RM 219.60 + Free Gift

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Need Help?
需要帮助吗?

FAQ  常见问题

Is this test approved by the Malaysia Ministry of Health (KKM)?
Yes, this test is registered and approved by the Medical Devices Authority (MDA) which is the medical devices division under the Ministry of Health.

Is this test accurate?

Gmate Saliva Antigen Test Kit is certified by the Institute of Medical Research (IMR) that is has 96% accuracy based on 91% sensitivity and 100% specificity.

 

When should I use the test kit?
There there is no right time to use the test as you generally do not know when you are exposed to the Covid-19 virus. As the Covid-19 viral load in your saliva/nasopharyngeal peaks during the 5th day onwards, you could use the test on the 5th day of the infection. You can also test when you have been in high-risk area, if you have developed symptoms such as cough, flu, fever, difficulty breathing, tastelessness, and any symptoms pertaining to the Covid-19 virus, or if you just want a precaution and peace of mind.

I accidentally spit too much saliva into the saliva collection kit, will it affect the accuracy?
No, it will not affect the accuracy. However, do not spit lesser than the required amount into the saliva collection kit.

What is the recommended way to dispose the used test kits?
It is recommended that you put all the used items into the test kit box and tie up with a plastic bag before disposing it into the rubbish bin.

How likely would the results be false positive?
The chances of the kit showing a false positive is 0%, according to the IMR.

Other than drinking, smoking, eating 30 minutes before test, is there any other medical condition that can affect the test results?
No, there is not.

Can this be used by children?
Yes, it can be used by children of all ages who can perform the spitting procedure required.

Gmate is using saliva instead of deep throat saliva, is there a difference in the accuracy?
According to the American Journal of Infection Control, deep throat saliva samples has a sensitivity of 82% while saliva sample has a sensitivity of 83%. Therefore, both samples should show similar accuracy.

Can the test be done, right after brushing my teeth or usage of oral products?
No, you cannot. It needs to be 30 minutes after brushing the teeth or usage of oral products such as mouth wash.

If I am recently vaccinated, will my results show as positive?
No, vaccine would not cause a positive test result for PCR or antigen test. However, if you are infected even if you are vaccinated, you will be tested as positive.

I have accidentally exposed the test kit to high heat in my car, will the kit still be accurate?
The kit needs to be stored between 20°C to 30°C. High heat will affect the accuracy of the test. If this happens, please purchase a new kit.

Should I store the test kit in the fridge?
No, just store it in a cool place at home where it is around 20°C to 30°C.

Could other throat infection cause a false positive?
No, a throat infections that is not due to Covid-19 infection will not cause a false positive.

Would the bubbles formed from saliva affect the result?
No. However, the bubbles might hinder the tidal flow of the test kit due to insufficient sample. Hence, we recommend that you wait for 5 minutes before dropping the mixed samples.

Does the test kit detect different variants?
Yes, antigen kits detect the nucleocapside protein of the virus, and mutations happen on the spike protein. Hence, it does not affect the kit's ability to detect accurately.

此测试盒是否获得马来西亚卫生部(KKM)的批准?

是的,此唾液抗原快速测试剂盒已获得大马卫生部属下的医疗器材管理局 (MDA) 注册和批准。

 

这个检测准确吗?

Gmate 唾液抗原快速测试剂盒经由医药研究所认证拥有 91% 的敏感性及 100% 的特异性,整体准确性达 96%。

 

我应该在什么时候进行检测?

并没有最适合的检测时间,因为我们不会知道自己什么时候会接触到新冠病毒。由于唾液或鼻咽中的新冠病毒数量会在第 5 天达到最高,因此您可以在感染的第 5 天进行检测。如果有出现咳嗽、感冒、发烧、呼吸困难、无味或任何与新冠病毒有关的症状、到过高风险地区或作为预防措施,都可以进行检测让自己安心。

 

不小心往唾液采集盒里吐了太多的唾液,这会影响准确性吗?

不会,它不会影响准确性。不要吐少于所需的唾液量就行了。

 

使用过的测试盒要怎么处理?

建议将所有用过的物品放入盒子内,用塑料袋封好后再丢入垃圾桶。

 

结果是假阳性的可能性有多大?

根据医药研究所(IMR),试剂盒出现假阳性的几率为 0%。

 

检测前 30 分钟,除了饮酒、吸烟、进食外,是否还有其他身体状况会影响结果?

没有。

这个适合小孩使用吗?

是的。所有年龄段的孩子都可以使用,只要他们可以进行吐口水的动作。

 

Gmate是用唾液代替深喉唾液,准确率有区别吗?

根据美国感染控制杂志,深喉唾液样本的敏感度为 82%,而唾液样本的敏感度为 83%。因此,两个样本将显示出相似的准确度。

 

可以在刷牙或使用口腔产品后立即进行检测吗?

不能。刷牙或使用漱口水等口腔产品后需要等30分钟再进行检测。

 

如果我最近接种了疫苗,我的结果会显示为阳性吗?

不会,接种疫苗后不会导致您的检测出现阳性结果。但如果被感染了,您的检测结果会出现阳性,即使您接种了疫苗。

 

我不小心将测试剂盒放在车内,在高温下测试剂盒仍然准确吗?

测试剂盒需要储存在 20°C 至 30°C 之间。高温会影响测试的准确性。如果发生这种情况,请购买新的测试剂盒。

 

我应该将试剂盒存放在冰箱中吗?

不。只需将其存放在家中阴凉处,温度约 20°C 至 30°C。

其他喉咙感染会导致检测出现假阳性吗?

不会。不是由新冠病毒感染引起的喉咙感染不会导致检测出现假阳性。

 

口水形成的泡泡会影响结果吗?

不会。但由于样品不足,泡泡可能会阻碍试剂盒进行工作。因此,我们建议您等待 5 分钟后再滴入混合样品到试剂盒。

 

试剂盒是否能检测到不同的变异病毒?

是的,抗原试剂盒能检测病毒的核衣壳蛋白和在突刺蛋白上发生的变异。因此,它不会影响试剂盒的检测能力。