The LYHER® antigen test kit (Colloidal Gold) for the novel coronavirus (SARS-CoV-2) is a diagnostic test used as an aid in the rapid diagnosis of infection with SARS-CoV-2. The test is used for the direct and qualitative detection of viral protein (the antigen: N protein) of SARS-CoV-2 in nasal mucus.
The test has been approved by the Ministry of Health(MOH) and Medical Device Authority of Malaysia and evaluation by Makmal Kesihatan Awam Kebangsaan (MKAK) shows that it is highly accurate with:
Sensitivity 93.1%
Specificity 100.0%
Positive Result :
If you see two red lines by C and T regions, it is a positive result. The lines can be distinct or faint. You are tested Covid-19 positive. RT-PCR test is still required for a confirmation of a Covid-19 case. You are advised to seek medical attention immediately even though you might have no symptoms
Do follow the current SOP given
Negative Result:
If you see one red line by C, and no line by T, it is a negative result. You probably do not have Covid-19. However, 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 If you develop symptoms later on, you 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 You will need to do another test with a new test kit.
- This test can only detect SARS-CoV-2 antigen in human saliva only, not other specimen.
- If the procedure is done incorrectly, it may cause inaccurate results.
- False negative results happen if: The concentration of antigen in a specimen is below the detection limit of the test. The specimen was not collected or transported properly.
- Positive results do not rule out co-infections with other pathogens. Therefore, 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.
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新型冠状病毒（SARS-COV-2）的Lyher®抗原测试试剂盒（胶体黄金）是一种诊断测试，用作SARS-COV-2快速诊断感染的帮助。 该测试用于鼻粘液中SARS-COV-2的病毒蛋白（抗原：N蛋白）的直接和定性检测。
该测试已获得马来西亚卫生部（MOH）和医疗设备授权的批准，Makmal Kesihatan Awam Kebangsaan（MKAK）批准了该测试，这表明它非常准确：
灵敏度93.1％
特异性100.0％
积极结果：
如果您看到C和T区域的两条红线，那是一个积极的结果。 线可能是独特的或微弱的。 您对COVID-19阳性进行了测试。 确认COVID-19病例仍然需要RT-PCR测试。 建议您即使您可能没有症状，也要立即寻求医疗护理
确实遵循当前给定的SOP
负结果：
如果您看到C的一条红线，而无需t线，那是一个负面结果。 您可能没有Covid-19。 但是，如果您怀疑您可能会接触该病毒，建议您继续监测症状
无效结果：
如果您看不到任何行或一行t，则是无效的结果。 测试无法使用，您需要使用新的测试套件进行另一个测试。
- 该测试只能在人类唾液中检测SARS-COV-2抗原，而不是其他标本。
- 如果过程不正确，则可能导致结果不正确。
- 如果：样品中抗原浓度的浓度低于测试的检测极限。 标本未正确收集或运输。
- 阳性结果不排除与其他病原体的共同感染。 因此，由于其在检测范围和灵敏度方面的限制，RTK抗原测试被用作筛选测试，RT-PCR用作定义COVID-19病例的验证性测试。
