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MATRIX EQUIVALENCE STUDY

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MATRIX EQUIVALENCE STUDY . ANTIBODY TEST KIT

LYHER® Novel coronavirus (2019-ncov) IgM/IgG Antibody Combo Test Kit Matrix Equivalence Study Study aim: A matrix equivalence study was performed to determine the effects of anticoagulants. Materials: A total number of 60 specimens were tested in this study. 20 specimens (5 negative, 5 high negative, 5 low positive and 5 high positive) were obtained from serum, plasma and whole blood respectively. Each specimen was divided into 4 aliquots: 3 of those were added to 0.3mg/ml of heparin lithium,20 mg/ml of EDTA, 10% of sodium citrate respectively, and 1 aliquot without anticoagulant. Methods: All aliquots were tested with LYHER® Novel coronavirus (2019-ncov) IgM/IgG Antibody Combo Test Kit. Sample preparation and sample testing were done by different laboratory technicians. Specimens were blinded to the testing technician and arranged in random. Results: Abbreviations: N means Negative; HN means High Negative; P means Positive; HP means High positive. IgG test results Specimen No.

HN.Serum-1 HN.Serum-2 HN.Serum-3 HN.Serum-4 HN.Serum-5 HN.plasma-1 HN.plasma-2 HN.plasma-3 HN.plasma-4 HN.plasma-5 HN.w.b.-1 HN.w.b.-2 HN.w.b.-3 HN.w.b.-4 HN.w.b.-5 N.Serum-1 N.Serum-2

Heparin lithium

EDTA

Sodium citrate

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

IgM test results Specimen without anticoag ulants

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Heparin lithium

EDTA

Sodium citrate

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

Specimen without anticoagu lants

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative

N.Serum-3 N.Serum-4 N.Serum-5 N.plasma-1 N.plasma-2 N.plasma-3 N.plasma-4 N.plasma-5 N.w.b.-1 N.w.b.-2 N.w.b.-3 N.w.b.-4 N.w.b.-5 HP.Serum-1 HP.Serum-2 HP.Serum-3 HP.Serum-4 HP.Serum-5 HP.plasma-1 HP.plasma-2 HP.plasma-3 HP.plasma-4 HP.plasma-5 HP.w.b.-1 HP.w.b.-2 HP.w.b.-3 HP.w.b.-4 HP.w.b.-5 P.Serum-1 P.Serum-2 P.Serum-3 P.Serum-4 P.Serum-5 P.plasma-1 P.plasma-2 P.plasma-3 P.plasma-4 P.plasma-5 P.w.b.-1 P.w.b.-2 P.w.b.-3 P.w.b.-4 P.w.b.-5

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Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive

Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive

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