Complete diagnostics program

onCOVID-19
Current clinical symptoms screening methods (cough and fever, etc) fail to find the viral
infections during the incubation period. To fully combat COVID-19, LmBio has developed
complementarily four types of diagnostic tests:

• Strongstep® Novel Coronavirus (SARS-CoV-2)

Multiplex Real-Time PCR Kit (detection for three genes,lyophilized)
• Strongstep® SARS-CoV-2 lgM/lgG Antibody Rapid Test
• Strongstep® SARS-CoV-2 Total Antibody Rapid Test
• Strongstep® SARS-CoV-2 Antigen Rapid Test
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Strongstep ®
Novel Coronavirus (SARS-CoV-2)
Multiplex Real-Time PCR Kit Specimen: throat swab/nasopharyngeal swab/sputum

(detection for three genes) Results come out in 2 hours, satisfactory performance done by
clinical trials. room-temperature transportation and storage.

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This kit provides multiplex detections of .I
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SARS-CoV-2's ORF1ab gene, E gene II
and N gene in a single tube. Reduce false :';-
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cycles
negative caused by mutation, At least one
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of the three positives can be used to determine the presence of virus infection.

An internal Control (IC) amplifying human RNase P gene was used to evaluate
extraction of RNA and detect PCR inhibition in PCR.

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Kit Components Package The kit is supplied as lyophilized PCR BEADS, which contains nucleic acid
• Lyophilized qPCR reagents 12x8-Strip Tubes (lyophilized)
amplification enzyme, reaction buffer, specific primers and probes.The kit can
• Positive control 1.5 ml Tube (lyophilized)
• PCR CAP 12x8-Strip Caps be directly put into qPCR instrument after adding sample and water.
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COVID-19 total antibody,

Specimen: Whole Blood/ Serum/Plasma
lgM/lgG Combo Rapid Test Results come out in 15 minutes, proven auxiliary to molecular
tests

Annbo<ly detectiop
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incubation •
fever !

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1)The first-visit suspected patients(no molecular results or molecular negative), if antibody

positive, should be managed as confirmed case; if antibody negative, it suggests to do PCR
again, and test antibody after one week.

-14 7 0 7 14 21 28 35 42
Days after on.set
2)The asymptomatic close contacts or investigation crowd, if antibody positive, no matter
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how the PCR result is, should be managed as carriers; if antibody negative, it suggests to
do PCR firstly and follow up with antibody detection, it can be excluded from COVID infection
if results negative again.

Test Sensitivity Specificity 3) For asymptomatic quarantined-14-days people, if antibody positive, it suggests to do PCR
Total antibody 93.1% 100% again and be kept under observation.
(161/173) (33/33) All test results need to be combined with the patient's clinical symptoms and signs, and
lgG 82.7% 100%
the interpretation of the test results must follow the local diagnostic guidelines in each country.
{143/173) (33/33)
Regerence: Diagnosis and treatment plan for the novel coronavirus disease (COVID-19)
lgM 64.7% 100%
(112/173) (33/33) http://www.nhc.gov.cn/yzygj/s7652m/202003/a31191442e294 74b98bfed5579d5af95.shtml
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Product package Method of operation of kit illustrated

.. an o
"'db o Apply 10µL of serum, plasma or Add 2-3 drops of buffer
whole blood to the sample well.

•
to sample well

Waiting for 15 minutes

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reading result
lgM and lgG Negative
::...=--
Positive

C01-m-H
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lndivdually Packed Test Devices:20

Dilution Buffer: 1 *Sml lgM Positive lgG Positive

Package insert: 1 Note:Control bst'ld fails to appear should be regarded as inYalid results

Apply 3 drops (120-150 µL) of serum, plasma or

whole blood to the sample well.

C T C T C T

cuo· 0 QI
Lf',m,n:.ao Waiting for 15 minutes
�'"'•"""t!•uti reading result positive negative

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Strongstep®
SARS-CoV-2 Antigen Rapid Test Specimen: throat swab/nasopharyngeal swab/sputum
Results come out in 15 minutes, very suitable for mass-screening

Sampling illustration Swab

tonsils

in the area of the

(J)Nasopharyngea/ swab
tonsils
@Oropharyngeal swabs
®Sputum

Product package Method of operation of kit illustrated

Remove the test card from the foil bag

Sample Treatment
Solution 10 drops Add 3 drops of specimen solution to
round sampling hole

Squeeze the tube and

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rotate the swab 15 times C T

positive negative
Waiting for 15 minutes
reading result
C r

Invalid
• lndivdually Packed Test Devices:20
• Extraction Buffer:2*12ml
• Extraction Tubes:20