CALTH - AllCheck COVID-19 IgG/IgMAllCheck COVID-19 IgG/IgM

Is a rapid immunochromatographic test for the qualitative detection of IgM and IgG Antibodies to the SARS-CoV-2 in human serum, plasma, venous or capillary whole blood. Results from the AllCheck COVID-19 IgG/IgM should not be used as the sole basis for diagnosis.

    Features

  • Rapid testing for SARS-CoV-2 antibodies within 10 minutes
  • Just 10㎕ of specimen : serum, plasma or whole blood
  • Suitable for Point-of-Care testing
  • No need for extra equipment
  • ※ Material provided : Device, Sample diluent
CALTH - AllCheck COVID-19 IgG/IgM

Test Procedure & Result Interpretation

  • Test Procedure

    AllCheck COVID-19 IgG/IgM
  • Result Interpretation

    CALTH - AllCheck COVID-19 IgG/IgM Result Interpretation
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Clinical Evaluation

For the Clinical sensitivity,
31 positive serum samples were collected from individuals who tested positive with a RT- PCR method for SARS-CoV-2 infection and were collected within 8-40 days after onset of symptoms. 29 of 31 were found be reactive with AllCheck COVID-19 IgG/IgM.

The day of collection relative to the onset of illness was recorded.

Time post symptoms onset Date of Symptoms onset Confirmation test date Blood collection date Days after onset AllCheck COVID-19 IgG/IgM
IgM IgG Result
8-14 days Apr. 09, 2020 Apr. 14, 2020 Apr. 22, 2020 11 POS POS POS
Apr. 12, 2020 Apr. 12, 2020 Apr. 19, 2020 8 NEG NEG NEG
Apr. 09, 2020 Apr. 11, 2020 Apr. 21, 2020 11 NEG POS POS
No symptom Apr. 12, 2020 Apr. 19, 2020 8 NEG POS POS
Mar. 14, 2020 Feb. 24, 2020 Mar. 24, 2020 10 POS POS POS
15-21 days Apr. 09, 2020 Apr. 12, 2020 Apr. 28, 2020 19 POS POS POS
No symptom Apr. 16, 2020 May. 04, 2020 18 POS POS POS
Apr. 04, 2020 Mar. 20, 2020 Apr. 28, 2020 16 POS POS POS
Apr. 14, 2020 Apr. 13, 2020 Apr. 28, 2020 14 POS POS POS
Apr. 04, 2020 Apr. 07, 2020 Apr. 20, 2020 16 NEG POS POS
Mar. 06, 2020 Mar. 09. 2020 Mar. 25, 2020 19 POS POS POS
Feb. 24, 2020 Feb. 27, 2020 Mar. 15, 2020 20 NEG POS POS
Mar. 14, 2020 Feb. 24, 2020 Apr. 01, 2020 18 POS POS POS
22-40 days Apr. 06, 2020 Apr. 08, 2020 May. 01, 2020 25 POS POS POS
Mar. 30, 2020 Apr. 02, 2020 May. 02, 2020 33 NEG POS POS
Mar. 30, 2020 Apr. 02, 2020 May. 02, 2020 33 POS POS POS
Apr. 12, 2020 Apr. 12, 2020 May. 04, 2020 22 NEG POS POS
Apr. 08, 2020 Apr. 13, 2020 May. 04, 2020 26 NEG POS POS
Mar. 27, 2020 Mar. 28, 2020 May. 04, 2020 38 POS POS POS
No symptom Apr. 01, 2020 May. 04, 2020 33 NEG POS POS
Mar. 19, 2020 Mar. 19, 2020 Apr.20, 2020 32 POS POS POS
No symptom Apr. 02, 2020 May. 04, 2020 32 POS POS POS
Mar. 27, 2020 Mar. 28, 2020 Apr.20, 2020 24 NEG POS POS
Mar. 18, 2020 Apr. 01, 2020 Apr.20, 2020 33 POS POS POS
No symptom Mar. 27, 2020 May. 06, 2020 40 NEG NEG NEG
No symptom Mar. 28, 2020 May. 06, 2020 39 NEG POS POS
Mar. 14, 2020 Mar. 28, 2020 Apr.20, 2020 37 NEG POS POS
No symptom Mar. 29, 2020 Apr.20, 2020 22 POS POS POS
Mar. 27, 2020 Mar. 31, 2020 Apr.20, 2020 24 POS POS POS
Mar. 28, 2020 Apr. 05, 2020 Apr.20, 2020 23 POS POS POS
Feb. 14, 2020 Feb. 24, 2020 Mar. 15, 2020 30 POS POS POS
Sensitivity (%) = (29/31) = 93.5%

For the Clinical specificity,
40 negative serum samples were collected from individuals who tested negative with a RT-PCR method for SARS-CoV-2 infection, 37 were found to be non-reactive with AllCheck COVID-19 IgG/IgM

Specificity AllCheck COVID-19 IgG/IgM
IgM IgG
RT-PCR
SARS-CoV-2 negative sample
95.0% (38/40) 97.5% (39/40)
Total 92.5%(37/40)

7 positive serum samples collected from asymptomatic patients, which were tested twice with a RT-PCR at early infection and before blood collection

Confirmation test date 2nd test date 2nd test results Blood collection date AllCheck COVID-19 IgG/IgM
IgM IgG Result
Asymptomatic patients Apr. 12, 2020 Apr. 19, 2020 POS Apr. 20, 2020 NEG POS POS
Apr. 16, 2020 May. 04, 2020 NEG May. 04.2020 POS POS POS
Apr. 01, 2020 May. 04, 2020 NEG May. 04.2020 NEG POS POS
Apr. 02, 2020 May. 04, 2020 POS May. 04, 2020 POS POS POS
Mar. 27, 2020 Apr. 18, 2020 NEG May. 06, 2020 NEG NEG NEG
Mar. 28, 2020 May. 05, 2020 POS May. 06, 2020 POS NEG POS
Mar. 29, 2020 Apr. 21, 2020 POS Apr. 20, 2020 POS POS POS
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Ordering information

Cat.No Product Type Pack Size Sample Type Stability Shelf Life
CHR09E AllCheck COVID-19 IgG/IgM Device 25T/Box Serum/
Plasma/
Whole Blood
1~30℃ 12months

Please contact info@thecalth.com

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