Healgen Rapid Swab Test

Certification

Approved by the UK government and Public Health England, the Healgen Rapid COVID-19 Antigen Test (Swab) is a lateral flow test designed to detect large numbers of SARS-CoV-2 infectious cases in a short space of time to prevent further onward transmission. The Rapid Swab Test is CE certified and MHRA registered.

Reliability

RELATIVE SPECIFICITY: 99.22%

Specificity is the proportion of patients without disease who have a negative test or true negative rate. These terms describe the operating characteristics of a test and can be used to gauge the credibility of a test result. 

ACCURACY: 99%

Accuracy is a measure of how close and corrects a stated value is to the actual real value being described. 99%

RELATIVE SENSITIVITY: 96.72%

Sensitivity is the proportion of patients with the disease who have a positive test, or the true positive rate. There are two types of sensitivity.

– If someone has the virus (or remnants of the virus) in their system, diagnostic sensitivity is the probability that a test will detect it.

– If someone is contagious with the virus, contagiousness sensitivity is the probability that a test will detect the virus.

Iris/VivaDiag Swab, Saliva and Antibody Tests

Certification

Alpha Pharma’s tests have been developed with safety and accuracy as paramount. Each test has undergone rigorous testing. The VivaDiag SARS-CoV-2Ag rapid test (swab test) and Iris VivaDiag COVID-19 IgM IgG rapid test (antibodies test) are manufactured in compliance with CE and WHO directives.

• Manufactured in compliance with CE directives
• Manufactured in compliance with WHO directives
• Registered with Italian Ministry of Health
• EUA (emergency use authorisation) granted by US Food & Drug Administration

Reliability

• 100% for negative patients
• Accuracy of up to 98% for positive patients, dependent on duration of infection
• Relative specificity: 100%
• Relative sensitivity (4 to 10 days of lgG and lgM infection time): 81.25%
• Relative sensitivity (11 to 24 days of lgG and lgM infection time): 97.1%
• Accuracy (4 to 10 days of lgG and lgM infection time): 88.25%
• Accuracy (11 to 24 days of lgG and lgM infection time): 98.3%